PF-07976016 + Danuglipron for Obesity

Recruiting in Anaheim (>99 mi)

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Must not be taking: Prohibited medications

Disqualifiers: Diabetes, Alcohol abuse, Drug use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 18 weeks

21 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to see how two study medicines, PF-07976016 and danuglipron, taken together affect the level of each other in the blood of participants who have overweight or obesity. The total number of weeks of the study is up to approximately 22 weeks (5.5 months).

Will I have to stop taking my current medications?

The trial does not specify exactly which medications you must stop, but it mentions that some medications are prohibited. It's best to discuss your current medications with the study team to see if they are allowed.

What data supports the effectiveness of the drug PF-07976016 + Danuglipron for obesity?

Danuglipron, a component of the treatment, is a glucagon-like peptide-1 receptor agonist (a type of drug that helps control blood sugar and weight) and has shown promise in reducing body weight in studies involving type 2 diabetes patients. Similar drugs targeting incretin receptors, like Retatrutide, have also shown potential in managing obesity. ^{1 2 3 4 5}

Is the treatment with PF-07976016 + Danuglipron generally safe for humans?

Danuglipron, a part of the treatment, has been tested in people with type 2 diabetes and was generally well tolerated. Most side effects were mild, like nausea and vomiting, and there were no serious changes in heart or blood tests. ^{1 2 4 5 6}

What makes the drug PF-07976016 + Danuglipron unique for treating obesity?

The drug PF-07976016 + Danuglipron is unique because it includes danuglipron, an oral small-molecule glucagon-like peptide-1 receptor agonist (GLP-1R agonist), which is typically administered as an injection in other treatments. This oral administration offers a more convenient option for patients compared to injectable GLP-1R agonists. ^{1 2 4 5 6}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for adults who are generally healthy but have overweight or obesity. Specific details about inclusion and exclusion criteria were not provided, so participants should inquire further to determine their eligibility based on other health factors and lifestyle considerations.

Inclusion Criteria

I can stay in a research unit for up to 95 days for the study.

My BMI is between 25 and 40, and I weigh more than 50 kg.

Exclusion Criteria

Presence of specified abnormalities on diagnostic assessments including clinical laboratory tests

History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence

Use of tobacco/nicotine containing products in excess of the equivalent of 5 cigarettes/day or 2 chews of tobacco/day

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive doses of PF-07976016 with and without PF-06882961 to evaluate pharmacokinetic interactions

18 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• PF-06882961
• PF-07976016

Trial Overview The study is testing how the body absorbs two medications, PF-07976016 and danuglipron (PF-06882961), when taken together by individuals with overweight or obesity. It aims to understand if these drugs affect each other's levels in the blood over a period of up to 22 weeks.

Participant Groups

Group I: Period 1 Experimental Treatment 2 Interventions

Participants will receive doses of PF-07976016 with and without PF-06882961

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Findings from Research

Retatrutide, a triple agonist targeting incretin receptors, has shown significant weight loss and reductions in glycated hemoglobin (HbA1c) in phase-2 trials for individuals with type 2 diabetes mellitus (T2DM), as well as substantial weight loss in non-T2DM individuals, although gastrointestinal side effects were noted.

Concerns about cardiovascular safety have emerged due to dose-dependent increases in heart rate and mild to moderate cardiac arrhythmias, highlighting the need for long-term cardiovascular outcome trials to assess its safety in obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retatrutide: a triple incretin receptor agonist for obesity management. Ray, A.[2023]

Sibutramine and orlistat are two FDA-approved medications for long-term obesity treatment, with distinct mechanisms of action: sibutramine acts as a reuptake inhibitor of monoamines, while orlistat inhibits pancreatic lipase to reduce fat absorption.

Dexfenfluramine has been withdrawn from the market due to its association with serious heart valve issues, highlighting the importance of safety monitoring in obesity pharmacotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent progress in obesity pharmacotherapy. Ryan, DH.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Danuglipron (PF-06882961) in type 2 diabetes: a randomized, placebo-controlled, multiple ascending-dose phase 1 trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

A phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of danuglipron (PF-06882961), an oral small-molecule glucagon-like peptide-1 receptor agonist, in Japanese adults with type 2 diabetes mellitus. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Retatrutide: a triple incretin receptor agonist for obesity management. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of the new, oral, small-molecule, GLP-1 receptor agonists orforglipron and danuglipron for the treatment of type 2 diabetes and obesity: systematic review and meta-analysis of randomized controlled trials. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Recent progress in obesity pharmacotherapy. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Discovery of Novel 5,6-Dihydro-1,2,4-triazine Derivatives as Efficacious Glucagon-Like Peptide-1 Receptor Agonists. [2023]