PF-07976016 for Obesity

Recruiting at 19 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Pfizer

Disqualifiers: Diabetes, Recent serious illness, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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. The study will compare the experiences of participants taking the study medicine (PF-07976016) to those of participants who take placebo (a lookalike substance that contains no active study medicine). The aim is to measure the body's response to the study medicine, including any changes in participants' body weight and how well they tolerate the study medicine.

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.

What safety information is available for PF-07976016 or similar anti-obesity medications?

Many anti-obesity medications have been linked to serious side effects, including heart and kidney problems, and some have been removed from the market due to safety concerns. It's important to monitor these medications closely to ensure they are safe for patients. ^{1 2 3 4 5}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• PF-07976016 (Other)

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

References

1. Netherlands 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. [2022]

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

Evolution of pharmacological obesity treatments: focus on adverse side-effect profiles. [2017]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Safety of drug therapies used for weight loss and treatment of obesity. [2018]

4. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Current updates in the medical management of obesity. [2019]

5. New Zealand pubmed.ncbi.nlm.nih.gov

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