OverweightPhase 1NCT06910839
Study to Learn About How the Study Medicines Called PF-07976016 and PF-06882961 Are Taken Up by the Body, and if Either of Them Change How the Body Processes the Other Medicine in Otherwise Healthy Adults With Overweight or Obesity
A Phase 1 study testing PF-07976016 and PF-06882961 in people with Overweight and Obesity, run by Pfizer at 1 site in United States.
Trial summary
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 participants who have overweight or obesity. The total number of weeks of the study is up to approximately 22 weeks (5.5 months). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- PF-07976016 and PF-06882961
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2025to 20 May 2025
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and non-pregnant, non-breastfeeding female, 18 to 65 years of age
- BMI 25 to 40 kg/m2 and a total body weight > 50 kg (110 lb)
- Willing and able to comply with all study procedures including staying a research unit for up to 95 days
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
- A positive urine drug test.
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
About this study
Official title: A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO EVALUATE THE PHARMACOKINETIC INTERACTIONS BETWEEN PF-07976016 AND PF-06882961 IN OTHERWISE HEALTHY ADULT PARTICIPANTS WITH OVERWEIGHT OR OBESITY
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 participants who have overweight or obesity.
The total number of weeks of the study is up to approximately 22 weeks (5.5 months).
- Conditions
- Overweight, Obesity
- Being tested
- PF-07976016, PF-06882961
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07976016Drug
PF-07976016 oral tablets
PF-06882961Drug
PF-06882961 oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Period 1 | Experimental | Participants will receive doses of PF-07976016 with and without PF-06882961 Receives: Drug: PF-07976016; Drug: PF-06882961 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady state area under the concentration-time profile for PF-07976016
Measured: From 0 Hours to 24 Hours following steady-state dose
Steady state maximum observed concentration (Cmax) for PF-07976016
Measured: From 0 Hours to 24 Hours following steady-state dose
Steady state area under the concentration-time profile danuglipron
Measured: From 0 Hours to 24 Hours following steady-state dose
Steady state maximum observed concentration (Cmax) for danuglipron
Measured: From 0 Hours to 24 Hours following steady-state dose
Secondary outcomes (1)
Number of participants with treatment emergent adverse events
Measured: First dose (Day 1) through 28-35 days after final dose (approximately 18 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start13 Mar 2025
- Primary completion1 May 2025
- Study completion20 May 2025
Why it stopped: The sponsor has made the decision to discontinue development of danuglipron (PF-06882961). As such, this study was discontinued prior to PF-06882961 administration.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Fixed Sequence
- Masking
- None (open label)
- Enrolment
- 21 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
- NCT06910839
- Sponsor's protocol ID
- C5541009
- Status last verified
- Aug 2025
- First submitted
- 12 Mar 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO EVALUATE THE PHARMACOKINETIC INTERACTIONS BETWEEN PF-07976016 AND PF-06882961 IN OTHERWISE HEALTHY ADULT PARTICIPANTS WITH OVERWEIGHT OR OBESITY
- ClinicalTrials.gov ID
- NCT06910839
- Acronym / sponsor ID
- C5541009
- Conditions
- Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor has made the decision to discontinue development of danuglipron (PF-06882961). As such, this study was discontinued prior to PF-06882961 administration.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 4 Apr 2025 (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 study is to see how two study medicines, PF-07976016 and danuglipron, taken together affect the level of each other in the blood of participants who have overweight or obesity.
The total number of weeks of the study is up to approximately 22 weeks (5.5 months).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Fixed Sequence
| Arm | Type | Receives |
|---|---|---|
| Period 1 | Experimental | Drug: PF-07976016, Drug: PF-06882961Participants will receive doses of PF-07976016 with and without PF-06882961 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and non-pregnant, non-breastfeeding female, 18 to 65 years of age
- BMI 25 to 40 kg/m2 and a total body weight > 50 kg (110 lb)
- Willing and able to comply with all study procedures including staying a research unit for up to 95 days
Key exclusion criteria (6 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
- A positive urine drug test.
- History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence
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-07976016PF-07976016 oral tablets | Drug | Period 1 |
| PF-06882961PF-06882961 oral tablets | Drug | Period 1 |
Primary outcome
Steady state area under the concentration-time profile for PF-07976016
Time frame: From 0 Hours to 24 Hours following steady-state dose
Steady state maximum observed concentration (Cmax) for PF-07976016
Time frame: From 0 Hours to 24 Hours following steady-state dose
Steady state area under the concentration-time profile danuglipron
Time frame: From 0 Hours to 24 Hours following steady-state dose
Steady state maximum observed concentration (Cmax) for danuglipron
Time frame: From 0 Hours to 24 Hours following steady-state dose
1 secondary outcome
Number of participants with treatment emergent adverse events
Time frame: First dose (Day 1) through 28-35 days after final dose (approximately 18 weeks)
Results and safety
The study was stopped early (reason given: The sponsor has made the decision to discontinue development of danuglipron (PF-06882961). As such, this study was discontinued prior to PF-06882961 administration.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-07976016 and PF-06882961 in people with Overweight and Obesity, run by Pfizer at 1 site in United States.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: The sponsor has made the decision to discontinue development of danuglipron (PF-06882961). As such, this study was discontinued prior to PF-06882961 administration.). Results are not available in the source record.
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?
Steady state area under the concentration-time profile for PF-07976016 (time frame: From 0 Hours to 24 Hours following steady-state dose). The study lists 4 primary outcomes in all. 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 7 Aug 2025.