PF-07976016 + Danuglipron for Obesity

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on how two medications, PF-07976016 and danuglipron, interact in the blood when taken together by individuals with overweight or obesity. Researchers aim to determine if these drugs can effectively manage weight. Participants should have a BMI between 25 and 40 and weigh more than 110 pounds. The trial requires a significant commitment, including a stay at a research unit for up to 95 days. As a Phase 1 trial, the research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the study medicine PF-07976016 is still under examination for its effects and safety in treating obesity. Concerns about liver safety with similar treatments led to the discontinuation of a related drug. However, PF-07976016 remains under study.

Danuglipron, in contrast, has undergone testing in several studies. Participants with obesity experienced significant weight loss, but some studies halted due to safety concerns.

Both treatments are in the early testing stages for this use, so detailed safety information remains limited. These early trials primarily focus on participants' tolerance of the treatment. More safety information will become available as further studies conclude. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about PF-07976016 and Danuglipron for treating obesity because these treatments target the condition in a novel way. Unlike traditional options that focus on appetite suppression or metabolic rate enhancement, PF-07976016 and Danuglipron work by potentially modulating specific pathways involved in glucose metabolism and energy balance. This new mechanism of action could offer more effective weight management for patients who struggle with existing treatments. Additionally, the combination of these two drugs might amplify their individual benefits, providing a more comprehensive approach to tackling obesity.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that danuglipron (PF-06882961) may aid in weight loss. In studies, participants taking danuglipron lost between 8% and 13% of their weight over 32 weeks. Other studies over 26 weeks reported weight loss between 5% and 9.5%. These findings suggest that danuglipron could be useful for managing obesity. In this trial, participants will receive doses of PF-07976016 with and without danuglipron to evaluate their combined effects. Less information is available about PF-07976016, so further research is needed to understand its interaction with danuglipron. ^{1 3 4 5 6}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40539310/

Efficacy and safety of danuglipron (PF-06882961) in adults ... Efficacy and safety of danuglipron (PF-06882961) in adults with obesity: A randomized, placebo-controlled, dose-ranging phase 2b study. Diabetes Obes Metab ...

2. pfizer.com pfizer.com/news/press-release/press-release-detail/pfizer-announces-topline-phase-2b-results-oral-glp-1r

Pfizer Announces Topline Phase 2b Results of Oral GLP ... Danuglipron demonstrated mean placebo-adjusted weight reductions ranging from -8% to -13% at 32 weeks and -5% to -9.5% at 26 weeks ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04707313

NCT04707313 | A Study to Evaluate the Efficacy and ... The study will compare the experiences of participants taking the study medicine (PF-06882961) to those of participants who take placebo (a look- alike ...

4. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/abs/10.1111/dom.16534

Efficacy and safety of danuglipron (PF‐06882961) in adults ... Efficacy and safety of danuglipron (PF-06882961) in adults with obesity: A randomized, placebo-controlled, dose-ranging phase 2b study · PEER ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2805054

Efficacy and Safety of Oral Small Molecule Glucagon-Like ... This randomized clinical trial investigates the efficacy, safety, and tolerability of danuglipron treatment for 16 weeks in adults with type ...

6. pfizer.com pfizer.com/news/press-release/press-release-detail/pfizer-provides-update-oral-glp-1-receptor-agonist

Pfizer Provides Update on Oral GLP-1 Receptor Agonist ... Pfizer Inc. (NYSE: PFE) today announced the decision to discontinue development of danuglipron (PF-06882961), an oral glucagon-like peptide-1 (GLP-1) receptor ...