ObesityPhase 2NCT06717425
A Study to Learn About the Study Medicine Called PF-07976016 in Adults With Obesity
A Phase 2 study testing PF-07976016 in people with Obesity, run by Pfizer at 38 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Obesity
- What is being tested?
- PF-07976016
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 263 participants
- Where
- 38 sitesin 3 countries
- Study dates
- 9 Dec 2024to 12 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
38 sites in 3 countries.
38 sites in 3 countries
United States28 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Clinical & Translational Research Center
Aurora, Colorado, 80045
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Elligo Clinical Research Center
Austin, Texas, 78704
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78749
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Capital Area Research, LLC
Camp Hill, Pennsylvania, 17011
StudyMetrix Research
City of Saint Peters, Missouri, 63303
Velocity Clinical Research, Dallas
Dallas, Texas, 75230
UT Southwestern Medical Center
Dallas, Texas, 75390
East-West Medical Research Institute
Honolulu, Hawaii, 96814
Westside Center for Clinical Research
Jacksonville, Florida, 32205
L-MARC Research Center
Louisville, Kentucky, 40213
New Horizon Research Center
Miami, Florida, 33165
AMR Clinical
Norman, Oklahoma, 73069
Cornerstone Nutrition and Diabetes
Norman, Oklahoma, 73069
Renstar Medical Research
Ocala, Florida, 34470
Renstar Medical Research
Ocala, Florida, 34471
Rochester Clinical Research, LLC
Rochester, New York, 14609
St Johns Center for Clinical Research
Saint Augustine, Florida, 32086
Artemis Institute for Clinical Research
San Diego, California, 92103
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
Chrysalis Clinical Research
St. George, Utah, 84790
Southwest Internal Medicine, PC
St. George, Utah, 84790
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291
Accellacare - Wilmington
Wilmington, North Carolina, 28401
Selma Medical Associates
Winchester, Virginia, 22601
Canada5 sites
Dawson Clinical Research Inc.
Guelph, Ontario, N1H 1B1
The Wharton Medical Clinic Clinical Trials Inc.
Hamilton, Ontario, L8L 5G8
Milestone Research Inc.
London, Ontario, N5W 6A2
Ocean West Research Clinic
Surrey, British Columbia, V3Z 2N6
Canadian Phase Onward
Toronto, Ontario, M3J 0K2
Poland5 sites
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, 80-546
Centrum Medyczne Pratia Gdynia
Gdynia, Pomeranian Voivodeship, 81-338
Ekamed
Lublin, Lublin Voivodeship, 20-718
Medicome Sp. z o. o.
Oświęcim, Lesser Poland Voivodeship, 32-600
Centrum Zdrowia Metabolicznego Pawel Bogdanski
Poznan, Greater Poland Voivodeship, 60-589
About this study
Official title: 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
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.
- Conditions
- Obesity
- Being tested
- PF-07976016, Placebo
- Keywords
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07976016Drug
Taken once daily
PlaceboDrug
Taken once daily
| Study group | Role | What they receive |
|---|---|---|
| PF-07976016 Dose 1 | Experimental | Not described Receives: Drug: PF-07976016 |
| PF-07976016 Dose 2 | Experimental | Not described Receives: Drug: PF-07976016 |
| PF-07976016 Dose 3 | Experimental | Not described Receives: Drug: PF-07976016 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in body weight
Measured: Baseline to Week 16
Secondary outcomes (1)
Number of participants with treatment emergent adverse events
Measured: From first dose (Day 1) up to 28-35 days after final dose, a total of approximately 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start9 Dec 2024
- Primary completion23 Oct 2025
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blind (investigator and participant), sponsor-open, placebo-controlled study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717425
- Sponsor's protocol ID
- C5541010
- Other IDs
- 2024-513679-42-00
- Status last verified
- Feb 2026
- First submitted
- 2 Dec 2024
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06717425
- Acronym / sponsor ID
- C5541010
- Conditions
- Obesity
- Keywords
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 23 Oct 2025 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- This is a randomized, double-blind (investigator and participant), sponsor-open, placebo-controlled study.
| Arm | Type | Receives |
|---|---|---|
| PF-07976016 Dose 1 | Experimental | Drug: PF-07976016 |
| PF-07976016 Dose 2 | Experimental | Drug: PF-07976016 |
| PF-07976016 Dose 3 | Experimental | Drug: PF-07976016 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-07976016Taken once daily | Drug | PF-07976016 Dose 1, PF-07976016 Dose 2, PF-07976016 Dose 3 |
| PlaceboTaken once daily | Drug | Placebo |
Primary outcome
Percent change from baseline in body weight
Time frame: Baseline to Week 16
1 secondary outcome
Number of participants with treatment emergent adverse events
Time frame: From first dose (Day 1) up to 28-35 days after final dose, a total of approximately 21 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
38 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-07976016 in people with Obesity, run by Pfizer at 38 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Canada, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline in body weight (time frame: Baseline to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026; AzTrials last refreshed its copy on 28 Oct 2026.