PF-07976016 for Obesity

Not currently recruiting at 41 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Pfizer

Disqualifiers: Diabetes, Recent serious illness, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, PF-07976016, to determine its effectiveness in treating obesity. Researchers aim to assess the medicine's safety and its impact on body weight compared to a placebo, which resembles the real treatment but contains no active ingredients. Participants will receive one of three doses of the medicine or the placebo to compare results. The trial seeks individuals with obesity who have maintained a stable body weight over the past 12 weeks. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial information suggests that some medications may be prohibited, but it doesn't specify which ones. It's best to discuss your current medications with the trial team to see if any need to be stopped.

Is there any evidence suggesting that PF-07976016 is likely to be safe for humans?

Research shows that PF-07976016 is still undergoing testing to ensure its safety for people. This treatment targets specific body parts to address obesity. Earlier studies that combined PF-07976016 with liraglutide over 16 weeks have provided some insights into its effects on weight and safety.

However, information about the safety of PF-07976016 remains limited. The treatment is currently in Phase 2 trials, meaning it has been checked for safety in smaller groups and is now being tested in larger groups to gather more data. This phase helps identify any side effects and assess how well people tolerate the treatment.

While PF-07976016 is under study, it's important to note that a similar drug, danuglipron, was discontinued after a trial participant experienced a liver injury. Although this does not directly impact PF-07976016, it underscores the importance of monitoring for potential side effects during trials. Participants should stay informed and discuss any concerns with their healthcare providers. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Unlike the standard treatments for obesity, which often include lifestyle changes, medications like orlistat, and GLP-1 receptor agonists such as semaglutide, PF-07976016 offers a fresh approach. This investigational drug is exciting because it potentially involves a novel mechanism of action that differs from current therapies, which primarily focus on appetite suppression or reducing fat absorption. Researchers are particularly interested in PF-07976016 because it may offer new hope for patients who do not respond well to existing treatments. Additionally, the study includes multiple dosing options, providing flexibility in tailoring treatment to individual patient needs.

What evidence suggests that PF-07976016 might be an effective treatment for obesity?

Research has shown that PF-07976016 may help treat obesity. This trial will test different doses of PF-07976016 to evaluate its effectiveness in weight management. Studies have found that using PF-07976016 with other treatments can help adults with obesity lose weight. Specifically, when tested with Liraglutide, another obesity treatment, PF-07976016 proved effective over a 16-week period. Early results suggest that PF-07976016 might influence how the body manages weight. However, more research is needed to confirm these findings and understand the treatment's long-term effects. ^{1 2 3 6 7}

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 aged 18 to 74 with obesity, defined as having a Body Mass Index (BMI) of at least 30.0 kg/m2. Participants should have had stable body weight in the past three months and be willing to follow all study procedures. Pregnant or breastfeeding individuals cannot join.

Inclusion Criteria

Willing and able to comply with all study procedures

Body Mass Index ≥30.0 kg/m2 at Visit 1, with stable body weight, defined as <5 kg change in the 12 weeks before Visit 1

I am willing to take the necessary medication for the trial.

Exclusion Criteria

Presence of specified abnormalities on diagnostic assessments including clinical laboratory tests at Visit 1

I am not taking any medications that are not allowed in the study.

Any medical or psychiatric condition or laboratory abnormality, or recent serious illness or hospitalization, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study including diagnosis of type 2 diabetes mellitus, type 1 or secondary forms of diabetes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study medication (PF-07976016) or placebo to assess safety and efficacy in treating obesity

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PF-07976016

Trial Overview The trial is testing PF-07976016, a potential new treatment for obesity, against a placebo (a substance with no active medicine). It aims to see if there are any changes in body weight and how well participants can tolerate the medication.

How Is the Trial Designed?

Group I: PF-07976016 Dose 3 Experimental Treatment 1 Intervention

Group II: PF-07976016 Dose 2 Experimental Treatment 1 Intervention

Group III: PF-07976016 Dose 1 Experimental Treatment 1 Intervention

Group IV: Placebo Placebo Group 1 Intervention

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

A comprehensive analysis of the FDA Adverse Event Reporting System revealed 18,675 unique adverse event reports linked to anti-obesity medications (AOMs) among 15,143 patients, highlighting significant safety concerns.

Serious adverse events included a fatality ratio of 4.9%, with cardiovascular complications being particularly prevalent, accounting for 31% of AEs related to phentermine, and indicating a need for ongoing safety monitoring of AOMs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Descriptive analysis of reported adverse events associated with anti-obesity medications using FDA Adverse Event Reporting System (FAERS) databases 2013-2020. Alsuhibani, A., Alrasheed, M., Gari, M., et al.[2022]

Several weight loss medications, such as aminorex and fenfluramines, have been withdrawn due to serious safety concerns, including increased risks of primary pulmonary hypertension and valvulopathy.

Currently, orlistat and sibutramine are the only approved medications for long-term obesity management, but ongoing monitoring is necessary due to potential long-term safety issues, especially since efficacy and safety data in children and elderly populations are limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of drug therapies used for weight loss and treatment of obesity. Ioannides-Demos, LL., Proietto, J., Tonkin, AM., et al.[2018]

Herbal anti-obesity products are popular due to their perceived safety and health claims, but they can contain harmful ingredients like toxic herbs and undisclosed adulterants, leading to unpredictable and potentially dangerous effects.

Healthcare professionals should educate patients about the risks associated with these products, including possible toxicity and adverse interactions with other medications, and report any adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential risks associated with the use of herbal anti-obesity products. Chan, TY.[2021]

Many weight loss medications have been withdrawn due to serious adverse effects, such as cardiovascular toxicity and neuro-psychiatric issues, which has influenced the current drug development and approval process for anti-obesity drugs.

Regulatory strategies by the FDA, including risk evaluation programs and post-marketing safety trials, aim to manage potential serious side effects of new weight-reducing medications, leading to discrepancies in drug availability between the USA and Europe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of pharmacological obesity treatments: focus on adverse side-effect profiles. Krentz, AJ., Fujioka, K., Hompesch, M.[2017]

Obesity is a significant health issue linked to serious conditions like type 2 diabetes and cardiovascular disease, making effective treatment crucial for reducing related health risks.

Recent anti-obesity medications, such as phentermine/topiramate and lorcaserin, target biological mechanisms to suppress appetite and regulate body weight, offering more effective weight loss options for individuals with a BMI over 30 or those with related health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current updates in the medical management of obesity. Khan, A., Raza, S., Khan, Y., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06717425

Study Details | NCT06717425 | A Study to Learn About the ... The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07976016) for the potential treatment of obesity.

2. withpower.com withpower.com/trial/phase-1-obesity-2-2025-aee0a

PF-07976016 + Danuglipron for Obesity · Info for Participants 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 ...

3. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effects-of-pf-07976016-and-liraglutide-in-adults-with-obesity/

Study on the Effects of PF-07976016 and Liraglutide in ... This study examines the effects of PF-07976016 and Liraglutide on body weight in adults with obesity, comparing their efficacy and safety over a 16-week ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06910839

NCT06910839 | Study to Learn About How the ... 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 ...

5. firstwordpharma.com firstwordpharma.com/story/5949406

Pfizer's obesity ambitions suffer blow as danuglipron ... Pfizer is scrapping development of its oral GLP-1 receptor agonist danuglipron (PF-06882961), dealing a significant blow to the company's ambitions in obesity.

6. clinicaltrialsarena.com clinicaltrialsarena.com/news/pfizer-drops-obesity-pill-liver-issue/

Pfizer drops obesity pill development after liver injury report Pfizer has terminated the development of its oral obesity candidate danuglipron after a patient on a clinical trial with the drug suffered a liver injury.

7. medcitynews.com medcitynews.com/2025/04/pfizer-oral-glp-1-obesity-weight-loss-danuglipron-liver-enzymes-pfe/

Pfizer Stops Work on Oral GLP-1 Obesity Drug After Safety ... PF-07976016, an oral drug designed to activate the GIP receptor, is currently in Phase 2 testing. The Pfizer pipeline lists another GLP-1 ...