Week of Apr 25 – May 1, 2026
Weekly GLP-1 trial and regulatory updates
Read a curated weekly view of trial changes, results, and regulatory events. Three trial drill-downs are free. Deeper trial drill-down is available with Bio1Up Plus. Prefer the newsletter format? Read GLP1 Observer ↗
This Week's Highlights
- Boehringer Ingelheim's survodutide achieves 16.6% weight loss in Phase 3 trial↗News
- FDA proposes excluding semaglutide and tirzepatide from 503B bulk compounding list↗Regulatory
- Zealand Pharma and Roche advance amylin analog petrelintide into Phase 3↗News
- Novo Nordisk initiates Phase 3 AMAZE 2 trial for NNC0487-0111Trial Changes
- Eli Lilly completes enrollment in Phase 3 orforglipron obesity trialTrial Changes
- Health Canada authorizes first generic version of Novo Nordisk's semaglutide↗News
Detailed Updates
otherFDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List
Source ↗The FDA proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list. This action would prevent outsourcing facilities from utilizing bulk drug substances to compound these medications at scale.
Phase 3ENDPOINT METBoehringer Ingelheim's survodutide achieves significant weight loss and metabolic improvement in Phase III SYNCHRONIZE-1 trial
Boehringer Ingelheim reported Phase 3 SYNCHRONIZE-1 topline data showing survodutide met co-primary endpoints in adults with obesity. Participants achieved up to 16.6% average weight reduction, with full data slated for the 2026 ADA Scientific Sessions.
Phase 3A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes
Novo Nordisk A/S
Primary Completion Date: 2026-12-25 → 2027-11-07(+317 days)
Phase 3A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain
Novo Nordisk A/S
Status: NOT_YET_RECRUITING → RECRUITING
Also: PrimaryCompletionDateChanged (+56 days)
Phase 3AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Novo Nordisk A/S
Status: NOT_YET_RECRUITING → RECRUITING
Phase 3A Research Study to See How Semaglutide Helps People With Excess Weight and Type 2 Diabetes Lose Weight
Novo Nordisk A/S
ResultsPosted: False → True
Phase 3A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity
Eli Lilly and Company
Status: RECRUITING → ACTIVE_NOT_RECRUITING
Phase 3A Master Protocol for Orforglipron (LY3502970) in Participants With Obesity or Overweight With and Without Type 2 Diabetes
Eli Lilly and Company
Status: RECRUITING → ACTIVE_NOT_RECRUITING
Phase 2A Study to Evaluate the Efficacy, Safety, and Tolerability of ASC30 Tablets in Participants With Type 2 Diabetes Mellitus
Ascletis Pharma (China) Co., Limited
Status: RECRUITING → ACTIVE_NOT_RECRUITING
Phase 2A Research Study on How Well Different Doses of the Medicine NNC0662-0419 Help People Living With Overweight or Obesity
Novo Nordisk A/S
Status: RECRUITING → ACTIVE_NOT_RECRUITING
Phase 2Aleniglipron Phase 2 in Type 2 Diabetes Mellitus
Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Status: RECRUITING → ACTIVE_NOT_RECRUITING
Also: CompletionDateChanged (-61 days)
Phase 2A Dose-Range Study of Aleniglipron (GSBR-1290) in Participants Living With Obesity or Overweight With at Least One Weight-related Comorbidity
Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Status: ACTIVE_NOT_RECRUITING → COMPLETED
Also: PrimaryCompletionDateChanged (+72 days)
Phase 2A Phase 2b, Dose-range Finding Study of the Efficacy and Safety of Multiple Doses of Aleniglipron (GSBR-1290) in Participants Living With Obesity or Overweight With at Least One Weight-related Comorbidity
Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Primary Completion Date: 2026-07-01 → 2025-10-24(-250 days)
Phase 2Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity
Kailera
Status: NOT_YET_RECRUITING → RECRUITING
Phase 1A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-4729 Injection in Healthy Subjects
Fujian Shengdi Pharmaceutical Co., Ltd.
Status: RECRUITING → COMPLETED
Phase 1A Research Study Looking at How NNC0487-0111 Affects Food Intake, Appetite and Metabolism After Meals in People With Obesity
Novo Nordisk A/S
Status: NOT_YET_RECRUITING → RECRUITING
Phase 1Effect of Maridebart Cafraglutide on How Oral Contraceptives Are Absorbed and Processed in the Body in Postmenopausal Female Participants Living With Overweight or Obesity
Amgen
Status: NOT_YET_RECRUITING → RECRUITING
Phase 1A Study of ABBV-295 Subcutaneous Injections to Assess Pharmacokinetics and Adverse Events in Healthy Adult Women Participants With Overweight or Obesity Taking Oral Contraceptives
AbbVie
Status: RECRUITING → ACTIVE_NOT_RECRUITING
Phase 1A Research Study Looking Into How NNC0662-0419 Works With Birth Control Pills and Emptying of the Stomach in Women Not Able to Become Pregnant With Excess Body Weight
Novo Nordisk A/S
Status: NOT_YET_RECRUITING → RECRUITING
Phase 1Investigating How NNC0487-0111 Regulates Insulin of Adults With Type 2 Diabetes
Novo Nordisk A/S
Status: NOT_YET_RECRUITING → RECRUITING
Novo Nordisk’s Rybelsus officially retired in US as ‘Ozempic pill’ takes branding center stage
Source ↗Novo Nordisk is retiring the Rybelsus brand name in the U.S. and repositioning the oral semaglutide treatment as the 'Ozempic pill' in a smaller tablet formulation with improved bioavailability.
Also covered by: prnewswire_pharma
Generic of Novo’s GLP-1 arrives in Canada, a ‘test case for the world’
Source ↗Health Canada authorized Dr. Reddy's to market the first generic version of semaglutide. This marks the first time a G7 nation has approved a generic competitor to Novo Nordisk's GLP-1 treatments.
Zealand Pharma and Roche to advance petrelintide, an amylin analog, to Phase 3 trials for chronic weight management
Source ↗Zealand Pharma and Roche will advance the long-acting amylin analog petrelintide into Phase 3 chronic weight management trials in H2 2026. A Phase 2 combination trial with enicepatide begins in Q2 2026.
Lilly touts 'encouraging' early days for Foundayo obesity launch, even as GLP-1 pill appears to lag Novo's
Source ↗Eli Lilly reported 20,000 patient starts for its oral GLP-1 Foundayo (orforglipron) since its April 2026 approval. The company is leveraging telehealth and the CMS GLP-1 Bridge program to boost early prescriptions.
Also covered by: biospace
Phase 2A Study of Weekly Oral Dose of Ecnoglutide (VRB-101) for Weight Maintenance in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
Verdiva Bio Dev Limited · 120 participants
Verdiva Bio Dev registered a 120-patient Phase 2 trial evaluating a weekly oral dose of ecnoglutide (VRB-101) for weight maintenance in participants with obesity or overweight.
Phase 1A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity
Novo Nordisk A/S · 120 participants
Novo Nordisk registered a Phase 1 trial to evaluate how cagrilintide influences food intake and appetite in 120 participants with overweight or obesity.
Phase 1A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS9531 Injection in Adolescents With Obesity
Fujian Shengdi Pharmaceutical Co., Ltd. · 48 participants
Fujian Shengdi Pharmaceutical registered a 48-patient Phase 1 trial to assess the safety, tolerability, and pharmacokinetics of HRS9531 injection in adolescents with obesity.
Phase 1A Study of SRSD384 in Overweight or Obese Participants
Sirius Therapeutics Co., Ltd. · 78 participants
Sirius Therapeutics registered a Phase 1 study to evaluate SRSD384 in 78 participants with overweight or obesity.
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 III trial
Source ↗Boehringer Ingelheim's survodutide achieved 16.6% weight loss in the Phase 3 SYNCHRONIZE-1 trial. The company also plans to advance its triple agonist BI 3034701 into Phase 2 trials in mid-2026.
Also covered by: fierce_biotech, stat_news
Structure Therapeutics to Present Aleniglipron, Amylin and Combination Data at the American Diabetes Association 86th Scientific Sessions
Source ↗Structure Therapeutics will present Phase 2b data for oral aleniglipron and amylin agonist ACCG-2671 at the ADA 86th Scientific Sessions. Presentations include preclinical combination data and GI tolerability profiles.
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