Ser sånn ut ja (litt rart de ikke bare skriver det rett ut):
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Det skrives ingenting om plateuing (i vekttap) i pressemeldinga, men fra presentasjonen:
“Up to 10.7% mean weight loss at week 42 versus 1.7% for placebo; further weight loss expected over time”
Jeg gjetter platå på rundt 15% for petrelintid alene i uke 68/72 for en 50/50 menn/kvinne-populasjon.
Det er faktisk ikke så ille. For dette er (trolig) en drug du kan stå på resten av livet.
Og toleransen er gull i kombo med samarbeidpartneren Roche sin GLP1/GIP CT388
Edit: Bare en liten kommentar om dosene her. ZEAL har gjort et godt arbeid med dosene her. Det er jo pretty obv. at fase III her blir i rommet 3-4 mg / ukentlig. Så Zealand har truffet fint, mens LLY tilsynelatende har klart å sette dosene for reta for høyt / lavt (4mg og 9mg, men sweet spot er trolig et sted i mellom der)
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AbbVie reports Positive Phase 1 Multiple Ascending Dose Results for ABBV-295, a Long-Acting Amylin Analog
2026-03-09 13:23:00
Gubra’s partner AbbVie today announced positive topline results from the 12 and 13-weeks Phase 1 Multiple Ascending Dose (MAD) trial showing that ABBV-295 was well tolerated with a dose-dependent significant and clinically meaningful weight loss, compared to placebo.
- ABBV-295 treatment showed clinically meaningful body weight reduction from -7.75% to -9.79% (least-squares mean) at week 12 (weekly dosing), to -7.86% to -9.73% at week 13 (every other week and monthly dosing after week 5)1
- ABBV-295 demonstrated a favorable tolerability profile at all evaluated dose levels. No serious adverse events were reported1
- Data support continued development of ABBV-295 as a potentially differentiated treatment for chronic weight management, with a non-incretin-based mechanism of action
“We are very encouraged by these clinical results. Obesity continues to be a growing global health challenge, with a well-recognized need for novel treatment options. These data demonstrate the potential of ABBV-295 to deliver meaningful body weight reduction with a favorable tolerability profile, supporting its differentiated positioning within the evolving obesity treatment landscape. We are very pleased with these results and we look forward to seeing AbbVie continue the advancement of the asset,” said Markus Rohrwild, CEO of Gubra.
Results from the trial
The multiple ascending dose (MAD) part of its Phase 1 study evaluated safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous ABBV-295, in adults with a mean body mass index (BMI) of less than 30 kg/m2. ABBV-295 is a long-acting amylin analog that represents a mechanistically distinct class from incretin-based therapies such as GLP-1 and GIP receptor agonists.Study enrollment mostly comprised male participants (88.3%). Different doses (2-14 mg), titrations and dose frequencies were tested in the study. ABBV-295 was generally well tolerated across all dose levels evaluated. The most commonly reported adverse events were gastrointestinal disorders, which were mostly mild, and predominantly occurred during the first 6 weeks of treatment.1
ABBV-295 demonstrated clinically meaningful, dose-dependent reductions in body weight from baseline, over a 12-13-week treatment period. In the ABBV-295 treated groups dose-dependent least-squares (LS) mean percentage change in body weight ranged from -7.75% to -9.79% at week 12 (for weekly dosing groups), to -7.86% to -9.73% at week 13 (for every other week dosing group and monthly dosing group after week 5), compared to -0.26% and -0.25% in the placebo group at week 12 and week 13, respectively.1
“Obesity is a complex, chronic disease that places a substantial burden on patients, healthcare systems and society, and there remains a critical need for therapies that combine efficacy with tolerability and support long-term adherence,” said Primal Kaur, M.D., senior vice president, global development of immunology, neuroscience, eye care and specialty at AbbVie. “We are encouraged by these early results for ABBV-295, which demonstrate meaningful weight loss together with a well-tolerated safety profile. These initial results further reinforce the potential of ABBV-295 as a novel therapeutic option for people living with obesity.”
Results from the single ascending doses (SAD) part and other cohorts from the MAD part of the study were announced previously. Full data from the study will be presented at a future scientific conference.
Summary of Phase 1 MAD Study Key Results 1 (Percent Change from Baseline in Body Weight at Week 12 and Week 13)
Cohort a LS Mean (95% CI) at week 12 b LS Mean (95% CI) at week 13 b All Placebo -0.26 (-1.89, 1.37) -0.25 (-1.88, 1.38) Cohort 3 (weekly dosing) -7.75 (-9.89, -5.61) - Cohort 4 (weekly dosing) -8.70 (-10.75, -6.65) - Cohort 5a (weekly dosing) -9.79 (-11.99, -7.59) - Cohort 5b (every other week dosing) -7.76 (-9.82, -5.70) -9.73 (-11.79, -7.67) Cohort 6 (monthly dosing after week 5) -6.74 (-8.70, -4.79) -7.86 (-9.80, -5.91) a Doses from 2mg to 14mg were tested using different dose escalations and dosing frequencies.
b LS mean estimates were derived using a Mixed Model for Repeated Measures (MMRM). Participants were required to adhere to the dosing plan and those unable to continue treatment were withdrawn from the study with no further efficacy data collected.
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Structure Therapeutics Reports Positive Topline Data from Phase 2 ACCESS II Trial with Once-Daily Oral Small Molecule GLP-1 Receptor Agonist, Aleniglipron
March 16, 2026
Placebo-adjusted mean weight loss of 16.3% (39 lbs) at 180 mg and 16.0% (37 lbs) at 240 mg at 44 weeks with no evidence of weight loss plateau in ACCESS II, demonstrating highest efficacy among oral GLP-1RAs and comparable efficacy to injectable GLP1-RAs
Continued weight loss up to 16.2% (40.5 lbs) observed with 120 mg dose in the ACCESS Open Label Extension (OLE) study at 56 weeks, with no evidence of weight loss plateau
Updated interim data from ACCESS OLE and Body Composition studies continue to support improved tolerability and low (2.0 – 3.4%) study drug discontinuations due to adverse events with the lower 2.5 mg starting dose
End-of-Phase 2 meeting with FDA scheduled in the second quarter of 2026;
Phase 3 initiation remains on track for 2H 2026Company to host conference call today at 8:30 a.m. Eastern Time
SAN FRANCISCO, March 16, 2026 (GLOBE NEWSWIRE) – Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today announced positive topline data from the ACCESS clinical program of aleniglipron for the treatment of people living with obesity and/or overweight with at least one weight related co-morbidity. This includes 44-week data from the Phase 2 ACCESS II study and interim data from the ongoing body composition study and the ACCESS open label extension (OLE) study. Aleniglipron is an investigational orally-available, once-daily, nonpeptide small molecule agonist of the glucagon-like-peptide-1 (GLP-1) receptor designed to address patient needs and accessibility.
In the Phase 2 ACCESS II study, aleniglipron achieved clinically meaningful and statistically significant placebo-adjusted mean weight loss of 16.3% (39 lbs; p<0.0001) at the 180 mg dose and 16.0% (37 lbs; p<0.0001) at the 240 mg dose at 44 weeks. In the ACCESS OLE study, aleniglipron achieved continued weight loss from 36 weeks, up to 16.2% (40.5 lbs) with 120 mg at 56 weeks. Both studies continue to demonstrate no evidence of weight loss plateau.
Aleniglipron continues to demonstrate a tolerability profile that is consistent with the GLP-1 receptor agonist class and a compelling safety profile with no off-target events. In ACCESS II, across all active arms in participants who reached doses 120 mg or higher from 28 to 44 weeks, there was only one (3.7%) adverse event (AE)-related treatment discontinuation.
With a median follow-up of 20 weeks, the tolerability data as of the February 20, 2026 cutoff date from the interim analyses of the OLE and the body composition studies provide further support that the use of 2.5 mg as a lower starting dose very meaningfully reduces the rate of AE-related discontinuations during the titration phase. In the OLE, with a median follow-up of 20 weeks, there was an overall AE-related discontinuation rate of 2%. In the body composition study, with a median follow-up of 20 weeks, there was an overall AE-related discontinuation rate of 3.4% in the aleniglipron arm.
Together, these positive efficacy, tolerability and safety findings continue to support the advancement of aleniglipron into Phase 3 clinical development, with initiation anticipated in the second half of 2026.
“The totality of efficacy and tolerability data across the Phase 2 program continue to demonstrate clear differentiation of aleniglipron, with the highest weight loss observed for an oral GLP-1RA to date and a safety profile appropriate for chronic use in a disease that impacts millions of people,” said Raymond Stevens, Ph.D., CEO of Structure Therapeutics. “The consistent weight loss observed across multiple studies to date reaffirms aleniglipron’s potential to be a best-in-class oral GLP-1, with injectable-like efficacy that could become a backbone oral small molecule therapy for obesity.”
“The weight-lowering data from these ACCESS studies, without apparent plateau by Week 56, are encouraging—particularly the weight loss from baseline of up to -15.3% vs +1.1% at 180mg in ACCESS II that hopefully will be confirmed in larger, longer-term studies,” said Julio Rosenstock, MD, Chair of the ACCESS program Steering Committee and Clinical Professor of Medicine, Univ. of Texas, Southwestern Medical Center. “In addition, the tolerability profile of starting at a low dose of 2.5 mg and the slow titration, positions the program ready for Phase 3 studies.”
ACCESS II Study - Evaluating higher doses up to 240 mg
ACCESS II is a randomized, double-blind, placebo-controlled, clinical study of aleniglipron that enrolled 85 adult participants living with obesity or overweight (defined as a BMI of greater than 25 kg/m2) with at least one weight-related comorbidity. The 44-week study was designed to evaluate two higher doses of aleniglipron. Participants started at 5 mg of aleniglipron (or placebo) and followed a 4-week titration schedule up to target doses of 120 mg, 180 mg and 240 mg.As reported in December 2025, at 36 weeks, each of the three dose cohorts in the ACCESS II study met statistical significance compared to placebo.
Results from the primary efficacy estimandi at 44 weeks are as follows:
Aleniglipron 120 mg Aleniglipron 180 mg Aleniglipron 240 mg Placebo
Mean percent change in body weight at 44 weeks compared to baseline
-13.6 -15.3 -15.0 +1.1
Placebo-adjusted mean percent change in body weight at 44 weeks compared to baseline
-14.7 -16.3 -16.0 -
P-value p<0.0001 p<0.0001 p<0.000Aleniglipron demonstrated a tolerability profile consistent with the GLP-1 receptor agonist class following repeated, once-daily dosing of up to 240 mg. As expected for the GLP-1 receptor agonist drug class, the most common AEs were gastrointestinal (GI)-related, and the two most common AEs in the titration phase were nausea and vomiting.
https://ir.structuretx.com/static-files/c7999175-be7e-40d4-8812-2305346536e3
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Nesten så jeg begynner å lure på om LLY etter hvert kommer til å kjøpe Structure.
Aleniglipron-molekylet funker åpenbart en del bedre enn orforgliporn for vektnedgang
En educated guess herfra blir at orforglipron-molekylet derimot fungerer bedre for blodsukkersenkning. Handler rett og slett om hva man targeter (eller treffer?). Mener å huske at det kommer en fase II med alenigliporn i t2d i løpet av året, så den vil gi en pekepinn.
Poenget her er at LLY da kan hevde at de ikke kjøper ut en konkurrent, men heller bare supplerer pipe overfor amerikanske konkuransemyndigheter.
Og med begge i porteføljen vil de da kunne matche oral wegovy på vektnedgang og trolig også blodsukkerkontroll (orfo slår allerede 14mg oral sema aka rybelsus).
Og begge medikamentene er small molecules, så de koster null og niks å lage vs. oral wegovy.
100000kr spørsmålet her blir om NVO kjenner sin besøkelsestid.
Liten tro på at Structure ikke har inngått partnerskap / ikke blitt kjøpt opp når 2026 runder av.
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Flere små selskaper forsøker å finne en plass i dette økosystemet:
PharmaShell® innesluter aktiva läkemedelssubstanser på atomnivå med en skyddande och extremt tunn beläggning (cirka 30 nm tjock) av långsamt upplösande, icke-toxiska, oorganiska oxider. Plattformen ger exceptionell kontroll över frisättningshastigheten, vilket möjliggör långa, jämna farmakokinetiska profiler med mycket låg kvot mellan maximal och minimal plasmakoncentration.
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Hvis de var villige til å legge 90 milliarder på bordet for Metsera så er vel Structure vel så aktuell. De er priset til oppkjøp, kanskje litt mer å gå på.
Samme vekttap som oral wegovy med en pille som koster brøkdelen å lage + at det ikke er noen restriksjoner på om man må ta den på tom mage. Kan bli en blockbuster det.
Solgte hele posisjonen min oppe på midten av $80-tallet. Da tenkte jeg at oppsiden begynte å bli liten. Vurderer å kjøpe tilbake nå, men makro / geopolitikk får meg til å sitte på gjerdet foreløpig.
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Lilly’s triple agonist, retatrutide, demonstrated significant reductions in A1C and weight in first Phase 3 trial for treatment of type 2 diabetes
March 19, 2026
For the primary endpoint, retatrutide lowered A1C by an average of 1.7% to 2.0% across doses at 40 weeks in TRANSCEND-T2D-1
Participants taking retatrutide 12 mg lost an average of 36.6 lbs (16.8%)
No weight loss plateau was observed with retatrutide, with participants continuing their weight loss trajectory through 40 weeks
INDIANAPOLIS, March 19, 2026 /PRNewswire/ – Eli Lilly and Company (NYSE: LLY) today announced positive topline results from TRANSCEND-T2D-1, a Phase 3 clinical trial evaluating the efficacy and safety of retatrutide, an investigational first-in-class GIP, GLP-1 and glucagon triple hormone receptor agonist, as an adjunct to diet and exercise. The trial enrolled adults diagnosed with type 2 diabetes with inadequate glycemic control with diet and exercise alone, and a mean duration of diabetes of 2.5 years. In the study, retatrutide met the primary and all key secondary endpoints, delivering superior A1C reduction and weight loss at 40 weeks compared to placebo, using both the efficacy and treatment-regimen estimands.1,2 For the primary endpoint, participants taking retatrutide achieved average A1C reductions of up to 2.0%, using the efficacy estimand. For a key secondary endpoint, participants taking retatrutide lost up to an average of 36.6 lbs (16.8%), using the efficacy estimand. Weight loss continued through the end of the treatment period.
“For many people with type 2 diabetes, it is a struggle to achieve both A1C control and weight loss, since obesity has historically been harder to treat for those with type 2 diabetes,” said Kenneth Custer, Ph.D., executive vice president and president, Lilly Cardiometabolic Health. “With triple agonist retatrutide, we set out to make a molecule that could help patients achieve substantial A1C reduction and weight loss. These results support the remarkable potential of this novel molecule for people living with type 2 diabetes, with up to 2% A1C improvement and nearly 17% weight loss in 40 weeks of treatment.”
Retatrutide also showed clinically meaningful improvements from baseline across key cardiovascular risk factors, including non-HDL cholesterol, triglycerides and systolic blood pressure.3
Consistent with the types of adverse events seen in clinical trials for other incretin-based therapies, the most common adverse events among participants treated with retatrutide (4 mg, 9 mg, 12 mg) were nausea (16.4%, 19.5%, 26.5%, respectively vs. 3.7% with placebo), diarrhea (18.7%, 26.3%, 22.8%, respectively vs. 4.5% with placebo) and vomiting (15.7%, 15.0%, 17.6%, respectively vs. 2.2% with placebo), and occurred primarily during dose escalation. Incidence of dysesthesia occurred in 4.5%, 2.3% and 4.4% (4 mg, 9 mg and 12 mg, respectively) of patients treated with retatrutide, compared to 0.0% with placebo. These dysesthesia events were generally mild, with a majority resolving during treatment. Discontinuation rates due to adverse events were 2.2%, 4.5% and 5.1% with retatrutide 4 mg, 9 mg and 12 mg, respectively, compared to 0.0% with placebo.
Detailed TRANSCEND-T2D-1 results will be presented at the American Diabetes Association Scientific Sessions in June and published in a peer-reviewed journal. Additional results from the retatrutide clinical trial program are expected over the next year.
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Zealand Pharma Establishes U.S. Research Hub in Cambridge, Massachusetts to Expand Drug Discovery Capabilities and Accelerate Medicine Creation
2026-03-24 15:00:00
Press release – No. 6 / 2026
Zealand Pharma Establishes U.S. Research Hub in Cambridge, Massachusetts to Expand Drug Discovery Capabilities and Accelerate Medicine Creation
New research hub in Cambridge, Massachusetts, in the greater Boston area, expands global discovery capabilities, combining Zealand Pharma’s more than 25 years of expertise in peptides and metabolic health with Boston’s biotech innovation ecosystem.
Copenhagen, Denmark and Boston, Massachusetts, March 24, 2026 - Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company transforming the future of metabolic health, today announced the establishment of a new research hub in Cambridge, Massachusetts, in the greater Boston area. The facility will serve as Zealand Pharma’s primary U.S. address and is expected to be operational from September 2026.
“The Cambridge hub is a tangible commitment and an important addition to our research footprint – complementing the strong and active research already taking place in Denmark and marking another important step in our ambition to become a leader in obesity and metabolic health,” said Adam Steensberg, President and Chief Executive Officer of Zealand Pharma.
Zealand Pharma’s Cambridge hub is designed to expand the Company’s global research capabilities and strengthen its ability to tap into world-class talent, technologies, and partnerships in one of the world’s leading life science ecosystems. The site will enhance the company’s research platform through AI-driven drug discovery, advanced automation, and next-generation molecule creation, accelerating the translation of scientific insight into innovative medicines.
Cambridge is a premier destination for startups, biotech, and life sciences with over 600 companies and is home to the world’s leading academia and research scholars. Located at 35 CambridgePark Drive, the site is a purpose-built lab property owned by Healthpeak (NYSE: DOC), supporting Zealand Pharma’s growth within the Cambridge innovation ecosystem. The research hub’s strategic location will enable close collaboration with local partners to develop artificial intelligence (AI), machine learning (ML), and automation models that enhance the quality and efficiency of drug design and expand the pharmacological reach of the Company’s research platform. This will expand Zealand Pharma’s research platform beyond its core peptide expertise, adding hybrid modalities for tissue-selective targeting such as antibody-peptide conjugates (APCs) and siRNAs, in support of the Company’s Metabolic Frontier 2030 strategy, and Zealand Pharma is actively recruiting to the site in Cambridge.
“Cambridge, Massachusetts is one of the world’s great engines of biotech innovation, and we are excited to build our research hub where the metabolic expertise of Denmark and multi-modal platform capabilities from Cambridge can come together,” said Utpal Singh, Chief Scientific Officer of Zealand Pharma. “This hub will deepen our discovery capabilities for medicine creation and help us move from idea to clinic faster.”
Founded in Denmark, with research hubs in Søborg, Copenhagen, and Cambridge, Massachusetts, Zealand Pharma is a global biotech built on nearly three decades of expertise in peptide discovery, design, and development, with a strong track record of stabilizing and advancing some of the most challenging peptide therapeutics.
In addition to the research laboratories, Zealand Pharma’s Cambridge site will include office space, meeting rooms, and collaborative areas for colleagues from across the organization, as the company expands its presence in the U.S.
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Foundayo is a prescription medicine available in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg oral tablets.
Ser ut som de også kuttet 36mg som de testet i fase 3
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Foundayo?
Er dette en slags 1. april-spøk fra LLY? I åpningstiden?
Rask ekstrapolering fra 17,2mg som maksdose blir da 10% vekttap på efficacy estimand og 9% på treatment. Over sammen tidsrom. Er vel 72 uker i ATTAIN-1
Au au au au au au au au
Not good
Edit: Se bort fra regnestykket her, 17,2 i tablettform er det samme som 36mg i kapselform, bare jeg som ikke skjønte hvordan dette hang sammen.
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Nei og nei:
Warnings – Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.
Do not use Foundayo if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
Do not use Foundayo if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Do not use Foundayo if you have had a serious allergic reaction to orforglipron or any of the ingredients in Foundayo.
MTC er sjelden, men ikke noe kult å ha på label likevel, er det? Skyldes i en del tilfeller MEN-2 mutasjon ser det ut som.
Spm her er om LLY har gått ned på dosen selv, eller om FDA har tvunget dosen ned.
Bra nytt for Novo og kanskje alle med peptidbaserte piller i pipe.
For Structure? Kanskje bra. Men kanskje dårlig. Vanskelig å si hva som vektlegges mest.
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Stemmer. Huh, så de brukte altså capsules i hele fase III’en, men switcha så til tablets for den godkjente medisinen. Altså, gir jo mening fra et produksjonsperspektiv. Og hvis virkestoffet er det samme, så betyr det vel lite for FDA. Bare stussa fordi Structure jo bytta fra capsules i fase I til tablets i i fase II, så tenkte det betød noe for godkjenning. Men greit å av og til bli minna på at man er en glad amatør! 
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En potensiell rakett. Er dialog med BP om avtale. Blir spennende å følge.
Er opsjonspriset pdd.
Se fra ca 35.00 min hva ledelsen sier om avtale
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ACHIEVE-4, the longest Phase 3 study of Lilly’s Foundayo (orforglipron) to date, reaffirmed its cardiovascular and overall safety profile as well as consistent improvements across key measures of cardiometabolic health
April 16, 2026
In ACHIEVE-4, Foundayo met the primary objective of non-inferiority vs. insulin glargine with a 16% lower risk of MACE-4 events and a 23% lower risk of MACE-3 events
In a pre-planned analysis, the risk of all-cause death was 57% lower for Foundayo vs. insulin glargine, showing the potential for more comprehensive health benefits
With these data, Lilly plans to submit Foundayo for the treatment of type 2 diabetes to the U.S. Food and Drug Administration by the end of Q2
INDIANAPOLIS, April 16, 2026 /PRNewswire/ – Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the Phase 3 ACHIEVE-4 trial evaluating the efficacy and safety of Foundayo (orforglipron), compared to insulin glargine in adults with type 2 diabetes and obesity or overweight at increased cardiovascular risk. ACHIEVE-4, the largest and longest study of Foundayo in type 2 diabetes to date, enrolled more than 2,700 participants across 15 countries. In the trial, Foundayo met the primary endpoint by demonstrating a non-inferior risk of major adverse cardiovascular events (MACE-4), including cardiovascular death, heart attack, stroke or hospitalization for unstable and sudden chest pain, compared to insulin glargine. In addition, Foundayo showed superior improvements in A1C and body weight at 52 weeks vs. insulin glargine, which persisted through 104 weeks of therapy. While not controlled for multiplicity, the risk of all-cause death was significantly lower for Foundayo vs. insulin glargine.
“Across seven Phase 3 studies enrolling more than 11,000 patients, Foundayo has demonstrated a consistent safety and efficacy profile,” said Thomas Seck, M.D., senior vice president of product development, Lilly Cardiometabolic Health. “ACHIEVE-4 adds a new dimension to that evidence — cardiovascular safety and a lower observed risk of all-cause death in patients who carry elevated cardiovascular risk. Together with the simplicity of a once-daily pill that requires no food or water restrictions, we believe Foundayo could be an important new treatment option for people with type 2 diabetes.”
In the trial, the risk of cardiovascular death, heart attack, stroke, or hospitalization for unstable sudden chest pain was 16% lower for Foundayo vs. insulin glargine (hazard ratio: 0.84; 95.0% CI: 0.59 to 1.20), meeting the prespecified criteria for demonstrating non-inferiority (upper limit of 95.0% CI of the hazard ratio < 1.8).1 The risk of all-cause death was 57% lower with Foundayo vs. insulin glargine (hazard ratio: 0.43; 95.0% CI: 0.25 to 0.75; nominal p = 0.002).2 Foundayo also showed clinically meaningful improvements from baseline across several cardiovascular risk factors, including non-HDL cholesterol, systolic blood pressure, triglycerides, and hsCRP.2
The overall safety and tolerability profile of Foundayo in ACHIEVE-4 was generally consistent with previous trials and with the GLP-1 class. The most common adverse events for patients taking Foundayo were nausea, vomiting, diarrhea, decreased appetite, and constipation. During the 52-week minimum treatment period, 10.6% of patients taking Foundayo discontinued treatment due to adverse events. ACHIEVE-4 included a thorough analysis of potential drug-induced liver injury (DILI), and these analyses confirmed there was no hepatic safety signal, consistent with all prior studies in the ACHIEVE and ATTAIN programs.
Lilly will submit Foundayo for the treatment of type 2 diabetes to the U.S. FDA by the end of the second quarter under the Commissioner’s National Priority Review Voucher.
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Zealand Pharma announces Boehringer Ingelheim’s novel glucagon/GLP-1 dual agonist survodutide achieved significant weight loss of 16.6% delivering meaningful metabolic improvement in people with obesity or overweight in Phase 3 trial
Company announcement – No. 10 / 2026
Zealand Pharma announces Boehringer Ingelheim’s novel glucagon/GLP-1 dual agonist survodutide achieved significant weight loss of 16.6% delivering meaningful metabolic improvement in people living with obesity or overweight in Phase 3 trial
- In SYNCHRONIZE-1, participants lost up to an average of 39.2 lb (17.8 kg) from baseline after 76 weeks of treatment with survodutide, a glucagon/GLP-1 receptor dual agonist1
- The trial met both weight loss primary endpoints and its key secondary endpoint evaluating waist circumference, a predictor of cardiometabolic risk, together demonstrating survodutide’s potential to broadly improve metabolic health1
- In addition to these positive results, Boehringer is advancing its broad metabolic health R&D program, exploring multiple pharmaceutical approaches to weight management including oral treatments.
- Survodutide is licensed to Boehringer Ingelheim from Zealand Pharma, with Boehringer Ingelheim solely responsible for the global development and commercialization of survodutide.
Copenhagen, Denmark, April 28, 2026 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company transforming the future of metabolic health, today announced that Boehringer Ingelheim has reported positive topline results from the Phase III SYNCHRONIZE-1 trial, in which survodutide (BI 456906) met the co-primary endpoints using both the efficacy and treatment-regimen estimands.*† Adults living with obesity or overweight, without type 2 diabetes, who were treated with survodutide experienced sustained weight loss of up to an average of 16.6% after 76 weeks using the efficacy estimand, a statistically significant decrease versus 3.2% in the placebo arm (p<0.0001).1 This level of weight loss supports survodutide’s potential as a clinically meaningful treatment option for people living with obesity or overweight.1 Full data from the Phase III trial will be presented at the upcoming American Diabetes Association’s (ADA) 2026 Scientific Sessions in June.
Zealand Pharma is eligible for high single to low double-digit percentage royalties on global sales of survodutide and EUR 315 million in potential outstanding milestone payments.
“We are highly encouraged by the SYNCHRONIZE-1 topline results announced today by Boehringer Ingelheim, supporting the promise of survodutide as a differentiated therapy for people living with overweight or obesity and associated metabolic dysfunction,” said David Kendall, MD, Chief Medical Officer of Zealand Pharma. “We look forward to the planned disclosure of the full data from SYNCHRONIZE-1 and SYNCHRONIZE-MASLD trials at the upcoming ADA 2026 Scientific Congress.”
The trial met its other co-primary endpoint, with up to 85.1% of adults treated with survodutide achieving a body weight reduction of ≥5% after 76 weeks of treatment, using the efficacy estimand, versus 38.8% in the placebo arm (p<0.0001).1 Initial analysis indicates that body weight reduction with survodutide was driven predominantly by loss of fat tissue, with lean mass contributing only a small proportion of total weight.1
In a key secondary endpoint, adults treated with survodutide experienced a statistically significant reduction in waist circumference – a clinical marker closely linked to visceral fat and cardiometabolic risk2 – after 76 weeks versus placebo.1 Excess visceral fat, particularly around the abdomen, is a known contributor to metabolic dysfunction and is closely connected to impaired liver function.3 As a dual glucagon/GLP‑1 receptor agonist,4 survodutide has the potential to address obesity while also supporting liver function, a key regulator of metabolic health.1
“I am encouraged by the data emerging from SYNCHRONIZE-1, which continue to demonstrate survodutide’s potential as a clinically meaningful treatment option for people with the disease of obesity,” said Professor Carel le Roux, M.D., Ph.D., Professor at University College in Dublin, Ireland, and Global Coordinating Investigator of the trial. “There is an urgent need for new therapies that go beyond weight reduction alone to support meaningful improvements in metabolic health. Survodutide’s dual agonism is particularly exciting, as it offers a promising approach to addressing this significant unmet need in care.”
Obesity is a chronic, complex metabolic disease that impacts more than 1 in 8 people worldwide in many different ways, and can have serious long-term consequences.5,6 It is closely linked to serious conditions including liver disease, type 2 diabetes and cardiovascular disease.7,8 Notably, up to 1 in 3 people living with obesity develop a serious liver condition called metabolic dysfunction-associated steatohepatitis (MASH), characterized by inflammation and liver damage.9
“Today’s SYNCHRONIZE-1 topline results strengthen our confidence in survodutide as a treatment candidate capable of addressing obesity and potentially offering targeted weight loss to help address connected conditions including liver disease,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma, Boehringer Ingelheim. “Survodutide has the potential to be the first global glucagon/GLP-1 dual agonist to help the more than 1 billion people living with obesity and MASH.”
Survodutide’s GLP‑1 agonism decreases appetite while increasing fullness and satiety,10 while its glucagon agonism is thought to directly act on the liver to reduce hepatic fat, regulate metabolic function, resolve inflammation, and improve fibrosis.11,12,13
As expected with GLP-1 based therapies, participants in the trial experienced gastrointestinal events, with discontinuations happening more frequently during the dose escalation phase.1 These events were both mild to moderate in severity and temporary, with no new safety concerns observed outside of what is expected for the GLP-1 class.
Survodutide is an investigational agent and has not been approved for use; its efficacy and safety has not been established. SYNCHRONIZE-1 is part of a comprehensive global Phase III obesity program, evaluating survodutide in people living with overweight and obesity, among key sub-populations.14 Additional trial results are expected to read out during 2026. Survodutide is also being studied in two global Phase III clinical trials LIVERAGE and LIVERAGE-Cirrhosis investigating the efficacy and safety of survodutide in adults with MASH and fibrosis stages 2 or 3 and in those with compensated MASH cirrhosis (fibrosis stage 4).15,16
Survodutide is the first in a broader portfolio of therapies being developed for people living with obesity or obesity and connected metabolic health conditions, with multiple approaches under investigation. This includes an investigational, potential first-in-class triple GLP-1, GIP, NPY2 receptor agonist peptide (BI 3034701), which will be entering Phase II in the middle of 2026, as well as additional experimental approaches including oral treatment options.
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Boehringer Ingelheim advances Gubra originated obesity triple agonist peptide into Phase 2 development
2026-04-28 12:46:00
Gubra today notes that its partner Boehringer Ingelheim plans to initiate Phase 2 clinical development in mid‑2026 of BI 3034701, an investigational, potential first‑in‑class triple GLP‑1, GIP and NPY2 receptor agonist peptide being developed for the treatment of obesity and related metabolic diseases based on Gubra‑discovered technology.
BI 3034701 represents a novel mechanism of action designed to address metabolic diseases through multiple complementary satiety pathways involved in body-weight regulation, supporting its potential role in obesity treatment. The planned transition into Phase 2 marks an important milestone and will further evaluate the compounds potential in people living with obesity, as BI 3034701 is the first asset originating from a Gubra research collaboration to advance into Phase 2 clinical development.
Under the collaboration and license agreement, Boehringer Ingelheim is responsible for global clinical development and commercialization of BI 3034701.
“The advancement of BI 3034701 into Phase 2 development is a significant milestone for Gubra. Our ambition is to contribute differentiated peptide therapies that address the underlying biology of obesity and weight management, with the potential to support meaningful and sustainable weight lossover time,” said Markus Rohrwild, CEO of Gubra. “It is the first asset from our research collaborations to reach this stage and reflects the strength of our peptide discovery platform and our focus on developing differentiated, first‑in‑class mechanisms in metabolic disease. We are pleased to see Boehringer Ingelheim continue to progress this program and take responsibility for its further development.
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