Investigating PF-07976016 for treating obesity in adults
A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE-RANGING STUDY OF PF-07976016 TO ASSESS SAFETY AND EFFICACY IN ADULT PARTICIPANTS WITH OBESITY
PHASE2 · Pfizer · NCT06717425
This study is testing a new medication called PF-07976016 to see if it can help adults with obesity lose weight safely.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Sponsor | Pfizer (industry) |
| Locations | 20 sites (San Diego, California and 19 other locations) |
| Trial ID | NCT06717425 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effects of a medication called PF-07976016 in adults with obesity. Participants will be divided into two groups, one receiving the active medication and the other receiving a placebo, to compare their experiences and measure changes in body weight and tolerance to the medication. The study will include adults aged 18 to 74 with a Body Mass Index of 30 or higher and stable body weight. The goal is to gather data on how the body responds to PF-07976016.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 74 with a Body Mass Index of 30 or higher and stable body weight.
Not a fit: Patients with type 2 diabetes or other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for individuals struggling with obesity.
How similar studies have performed: Other studies have explored treatments for obesity, but the specific approach with PF-07976016 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Male or non-pregnant, non-breastfeeding female, 18 to 74 years of age at Visit 1 * 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 * Eligible and willing to receive required background medicine * Willing and able to comply with all study procedures Key Exclusion Criteria: * 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. * Use of any prohibited prior or concomitant medication(s) * Presence of specified abnormalities on diagnostic assessments including clinical laboratory tests at Visit 1.
Where this trial is running
San Diego, California and 19 other locations
- Artemis Institute for Clinical Research — San Diego, California, United States (NOT_YET_RECRUITING)
- Westside Center for Clinical Research — Jacksonville, Florida, United States (NOT_YET_RECRUITING)
- New Horizon Research Center — Miami, Florida, United States (NOT_YET_RECRUITING)
- St Johns Center for Clinical Research — Saint Augustine, Florida, United States (NOT_YET_RECRUITING)
- Rophe Adult and Pediatric Medicine/SKYCRNG — Union City, Georgia, United States (RECRUITING)
- East-West Medical Research Institute — Honolulu, Hawaii, United States (NOT_YET_RECRUITING)
- L-MARC Research Center — Louisville, Kentucky, United States (RECRUITING)
- Rochester Clinical Research, LLC — Rochester, New York, United States (NOT_YET_RECRUITING)
- Alliance for Multispecialty Research, LLC — Norman, Oklahoma, United States (NOT_YET_RECRUITING)
- Cornerstone Nutrition and Diabetes — Norman, Oklahoma, United States (NOT_YET_RECRUITING)
- Capital Area Research, LLC — Camp Hill, Pennsylvania, United States (NOT_YET_RECRUITING)
- Elligo Clinical Research Center — Austin, Texas, United States (NOT_YET_RECRUITING)
- Texas Diabetes & Endocrinology, P.A. — Austin, Texas, United States (NOT_YET_RECRUITING)
- Velocity Clinical Research, Dallas — Dallas, Texas, United States (NOT_YET_RECRUITING)
- UT Southwestern Medical Center — Dallas, Texas, United States (NOT_YET_RECRUITING)
- Consano Clinical Research, LLC — Shavano Park, Texas, United States (NOT_YET_RECRUITING)
- Chrysalis Clinical Research — Saint George, Utah, United States (NOT_YET_RECRUITING)
- Southwest Internal Medicine, PC — Saint George, Utah, United States (NOT_YET_RECRUITING)
- Milestone Research Inc. — London, Ontario, Canada (NOT_YET_RECRUITING)
- Canadian Phase Onward — Toronto, Ontario, Canada (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity