berobenatide (PF-08653944) / Amneal, Pfizer - LARVOL DELTA

Pfizer details phase 3 sleep apnea trial for ex-Metsera obesity drug (Korea Biomedical Review) - "The company registered VESPER-OSA 1 (NCT07823608), a phase 3, randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe OSA and overweight or obesity, according to a listing posted to ClinicalTrials.gov on Sept. 16. The study lists an estimated start of Sept. 19 and completion in June 2028....The trial will enroll an estimated 258 adults with a body mass index of 27 or higher who have been diagnosed with OSA and use a breathing machine, known as positive airway pressure (PAP) therapy, to keep their airways open at night."

Trial status • Obesity • Sleep Apnea

A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Use a Breathing Machine (PAP) (VESPER-OSA 1) (clinicaltrials.gov) - P3 | N=258 | Not yet recruiting | Sponsor: Pfizer

New P3 trial • CNS Disorders • Genetic Disorders • Obesity • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Monthly Berobenatide (MET-097, PF-08653944) in Adults with Obesity: VESPER-3 1st Results (OBESITY WEEK 2026) - No abstract available

Clinical • Genetic Disorders • Obesity

APT3711: a potential once-monthly injectable for obesity and type 2 diabetes (EASD 2026) - "Based on this relationship, the projected human half-life of APT3711 is estimated at ~420-450 h, potentially exceeding that of the Phase 2b GLP-1 analog MET-097i... These findings indicate that APT3711 combines potent metabolic activity with significantly prolonged pharmacokinetics in preclinical models. The extended half-life observed across species supports the potential development of APT3711 as a once- monthly injectable therapy for obesity and type 2 diabetes. The PK profile may also enable development of a once-weekly oral formulation, potentially improving patient convenience and adherence compared with current GLP-1 therapies."

Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

SOLIS-1: A Study of PF-08653945 and PF-08653944 in Adults With Overweight or Obesity (clinicaltrials.gov) - P2 | N=940 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Metabolic Disorders • Obesity

Pfizer is also progressing a 10-study Phase 3 program and is targeting a potential berobenatide launch in 2028 (Pulse 2.0)

Launch • New P3 trial • Obesity

A Study to Learn About Safety and Effects of Once-monthly Treatment With Berobenatide in Adults With Obesity Disease in Japan (VESPER-JM) (clinicaltrials.gov) - P3 | N=197 | Not yet recruiting | Sponsor: Pfizer

New P3 trial • Genetic Disorders • Obesity

A Study to Learn About Safety and Effects of Once-weekly Treatment With Berobenatide in Adults With Obesity Disease in Japan (VESPER-JW) (clinicaltrials.gov) - P3 | N=180 | Not yet recruiting | Sponsor: Pfizer

New P3 trial • Genetic Disorders • Obesity

Pfizer Inc. (PFE) has launched VESPER-JM, a Phase 3 study in Japan that tests once-monthly berobenatide in adults with obesity, including some with type 2 diabetes (TipRanks) - "The study tests berobenatide, a once-monthly injection under the skin, against a placebo injection that has no active medicine. Berobenatide, also known as PF-08653944 or MET097, is designed to reduce body weight and improve related health markers for people living with obesity."

Trial status • Obesity • Type 2 Diabetes Mellitus

A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Weekly Compared to Placebo in Chinese Adults With Overweight or Obesity (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Pfizer

New P3 trial • Genetic Disorders • Obesity

A Study to Learn How the Study Medicine Called PF-08653944 is Taken up Into the Blood in Adults With Overweight or Obesity (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

Pfizer has axed two clinical-stage obesity programs, including a GLP-1 receptor agonist that came over in the $10 billion acquisition of Metsera. (FierceBiotech) - "The oral, fully biased, ultra-long-acting GLP-1 drug, dubbed MET-224o, was one of the rewards from Pfizer's successful resolution of the bidding war with Novo Nordisk last year to secure Metsera....The other, called MET-097o, was an oral formulation...The other clinical-stage obesity prospect to be scrapped by Pfizer this morning is PF-07976016...They included PF-07258669, an MC4R antagonist for malnutrition that had already seen its phase 1 study cut short earlier this year for business reasons....The last of Pfizer's abandoned assets was PF-07985631, which was in phase 1 development for nephropathy."

Discontinued • Cachexia • Obesity • Renal Disease

VESPER-5: A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D) (clinicaltrials.gov) - P3 | N=1044 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

VESPER-4: Efficacy and Safety of MET097 Once-Weekly in People With Overweight or Obesity (clinicaltrials.gov) - P3 | N=3578 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

A Study to Learn About the Effect of Study Medicine Called PF-08653944 on How Quickly the Stomach Empties Its Content in Healthy Adults With Overweight or Obesity (clinicaltrials.gov) - P1 | N=22 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity (clinicaltrials.gov) - P3 | N=954 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

A Study of PF-08653945 and PF-08653944 in Adults With Overweight or Obesity (SOLIS-1) (clinicaltrials.gov) - P2 | N=872 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Metabolic Disorders • Obesity

Berobenatide Phase 2b Program Summary (ADA 2026) - No abstract available

Late-breaking abstract • P2b data • Metabolic Disorders

The VESPER-2b Trial of Berobenatide in Adults with Overweight/Obesity and Type 2 Diabetes (ADA 2026) - No abstract available

Clinical • Late-breaking abstract • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Scaling Medical Treatment for Weight Management: Designing Berobenatide (MET-097, PF- 08653944) (ADA 2026) - No abstract available

Late-breaking abstract • Metabolic Disorders

CT-SY25-1.5: Symposium - The VESPER-1 OLE, -2 and -3 Trials of Berobenatide (MET-097, PF-08653944) an Ultra-Long-Acting GLP-1 Receptor Agonist for Weight Management (ADA 2026) - No abstract available

Late-breaking abstract • Metabolic Disorders

Robust Phase 2b Efficacy and Favorable Tolerability Support Monthly Dosing for Pfizer’s GLP-1 RA Berobenatide (Pfizer Press Release) - "The first clinical experience with the top weekly dose for berobenatide is being presented today for the first time. Results from a 32-week exploratory extension (Part B) of the Phase 2b VESPER-1 study showed a non-placebo-adjusted weight loss of 15.9%* with no plateau observed at 32 weeks on berobenatide (Week 60 of the overall study), in participants who escalated from placebo to 2.4 mg weekly berobenatide...Detailed results from the previously reported Phase 2b VESPER-3 study are also being presented today...In addition, data from the Phase 2b VESPER-2 study, which evaluated weekly dosing of berobenatide in adults with obesity or overweight and type 2 diabetes, showed dose dependent reductions from baseline were observed with berobenatide for both body weight and HbA1c."

New P3 trial • P2b data • Obesity • Type 2 Diabetes Mellitus

A Study of MET233 in Combination With MET097 in Individuals With Obesity or Overweight With or Without Diabetes (clinicaltrials.gov) - P1/2 | N=381 | Recruiting | Sponsor: Pfizer | N=132 ➔ 381 | Trial completion date: Mar 2027 ➔ Sep 2026 | Trial primary completion date: Jan 2027 ➔ Sep 2026

Enrollment change • Trial completion date • Trial primary completion date • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

VESPER-1: A Phase 2b Study to Examine the Safety and Efficacy of Once-Weekly MET097 in Adults With Obesity or Overweight (clinicaltrials.gov) - P2 | N=239 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity (clinicaltrials.gov) - P3 | N=954 | Not yet recruiting | Sponsor: Pfizer

New P3 trial • Genetic Disorders • Obesity