ObesityPhase 1NCT07508241
A Study to Learn About the Effect of Study Medicine Called PF-08653944 on How Quickly the Stomach Empties Its Content in Healthy Adults With Overweight or Obesity
A Phase 1 study testing PF-08653944 and Acetaminophen in people with Obesity and Overweight and/or Obesity, run by Pfizer at 1 site in United States.
Trial summary
This study looks at how a study medicine called PF-08653944 affects how quickly the stomach empties food after eating. It is being done in adults who are overweight or have obesity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight and/or Obesity, Overweight
- What is being tested?
- PF-08653944 and Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2026to 27 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥18 years at screening, male or female, generally healthy as determined by medical history, physical examination, laboratory tests, and ECG.
- Body mass index (BMI) 27-45 kg/m² and body weight >50 kg (110 lb).
- Participants with overweight or obesity
Who cannot join
- History or presence of clinically significant medical conditions, including but not limited to:
- --Cardiovascular, hepatic, renal, pulmonary, endocrine, hematologic, neurologic, gastrointestinal (including pancreatitis or gallbladder disease), or significant psychiatric disorders.
- Any form of diabetes, HbA1c ≥6.5%, or fasting plasma glucose ≥126 mg/dL.
- Prior exposure to a GLP-1 receptor agonist within 90 days before first dose, or prior participation in a study with PF-08653944.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, 06511
About this study
Official title: A PHASE 1, OPEN-LABEL, MULTIPLE DOSE STUDY TO INVESTIGATE THE IMPACT OF PF 08653944 ON GASTRIC EMPTYING IN ADULT PARTICIPANTS WITH OVERWEIGHT OR OBESITY
This study looks at how a study medicine called PF-08653944 affects how quickly the stomach empties food after eating. It is being done in adults who are overweight or have obesity.
Participants will receive the study medicine for a short period, and doctors will measure how the medicine moves through the stomach and monitor safety. The goal is to better understand how this medicine works in the body and to check for any side effects.
The information from this study may help researchers plan future studies of this medicine.
- Conditions
- Obesity, Overweight and/or Obesity, Overweight, Drug Interaction
- Being tested
- PF-08653944, Acetaminophen
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-08653944Drug
Also called MET097
Subcutaneous Injection
AcetaminophenDrug
Also called paracetamol
Oral suspension
| Study group | Role | What they receive |
|---|---|---|
| Period 1 | Experimental | Participants will receive a single oral dose of acetaminophen. Receives: Drug: Acetaminophen |
| Period 2 | Experimental | Participants will receive SC dose of PF-08653944 and single oral dose of acetaminophen. Receives: Drug: PF-08653944; Drug: Acetaminophen |
| Period 3 | Experimental | Participants will receive SC dose of PF-0865394. Receives: Drug: PF-08653944 |
| Period 4 | Experimental | Participants will receive SC dose of PF-0865394. Receives: Drug: PF-08653944 |
| Period 5 | Experimental | Participants will receive SC dose of PF-08653944 and single oral dose of acetaminophen. Receives: Drug: PF-08653944; Drug: Acetaminophen |
| Period 6 | Experimental | Participants will receive single SC dose of PF-08653944 and single oral dose of acetaminophen. Receives: Drug: PF-08653944; Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acetaminophen Pharmacokinetic (PK) Parameters: Maximum observed plasma concentration (Cmax)
To assess the effect of multiple SC doses of PF-08653944 on the plasma PK profile of acetaminophen, a marker for gastric emptying, in healthy adult participants with overweight or obesity.
Measured: Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
Acetaminophen PK parameters: Area under the plasma concentration (AUC)
To assess the effect of multiple SC doses of PF-08653944 on the plasma PK profile of acetaminophen, a marker for gastric emptying, in healthy adult participants with overweight or obesity.
Measured: Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
Acetaminophen PK parameters: Time to Maximum concentration (Tmax)
Measured: Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
Secondary outcomes (1)
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Measured: First dose through study completion, approximately 11 Weeks post last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start31 Mar 2026
- Primary completion27 Jan 2027 (estimated)
- Study completion27 Jan 2027 (estimated)
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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT07508241
- Sponsor's protocol ID
- C6491010
- Other IDs
- MET097-25-106
- Status last verified
- Jul 2026
- First submitted
- 27 Mar 2026
- Last updated
- 9 Jul 2026
- 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 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, MULTIPLE DOSE STUDY TO INVESTIGATE THE IMPACT OF PF 08653944 ON GASTRIC EMPTYING IN ADULT PARTICIPANTS WITH OVERWEIGHT OR OBESITY
- ClinicalTrials.gov ID
- NCT07508241
- Acronym / sponsor ID
- C6491010
- Conditions
- Obesity, Overweight and/or Obesity, Overweight, Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 27 Jan 2027 (estimated)
- Study completion
- 27 Jan 2027 (estimated)
- First posted
- 2 Apr 2026 (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.
This study looks at how a study medicine called PF-08653944 affects how quickly the stomach empties food after eating. It is being done in adults who are overweight or have obesity.
Participants will receive the study medicine for a short period, and doctors will measure how the medicine moves through the stomach and monitor safety. The goal is to better understand how this medicine works in the body and to check for any side effects.
The information from this study may help researchers plan future studies of this medicine.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Period 1 | Experimental | Drug: AcetaminophenParticipants will receive a single oral dose of acetaminophen. |
| Period 2 | Experimental | Drug: PF-08653944, Drug: AcetaminophenParticipants will receive SC dose of PF-08653944 and single oral dose of acetaminophen. |
| Period 3 | Experimental | Drug: PF-08653944Participants will receive SC dose of PF-0865394. |
| Period 4 | Experimental | Drug: PF-08653944Participants will receive SC dose of PF-0865394. |
| Period 5 | Experimental | Drug: PF-08653944, Drug: AcetaminophenParticipants will receive SC dose of PF-08653944 and single oral dose of acetaminophen. |
| Period 6 | Experimental | Drug: PF-08653944, Drug: AcetaminophenParticipants will receive single SC dose of PF-08653944 and single oral dose of acetaminophen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ≥18 years at screening, male or female, generally healthy as determined by medical history, physical examination, laboratory tests, and ECG.
- Body mass index (BMI) 27-45 kg/m² and body weight >50 kg (110 lb).
- Participants with overweight or obesity
Key exclusion criteria (4 listed)
- History or presence of clinically significant medical conditions, including but not limited to:
- --Cardiovascular, hepatic, renal, pulmonary, endocrine, hematologic, neurologic, gastrointestinal (including pancreatitis or gallbladder disease), or significant psychiatric disorders.
- Any form of diabetes, HbA1c ≥6.5%, or fasting plasma glucose ≥126 mg/dL.
- Prior exposure to a GLP-1 receptor agonist within 90 days before first dose, or prior participation in a study with PF-08653944.
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-08653944Also: MET097Subcutaneous Injection | Drug | Period 2, Period 3, Period 4, Period 5, Period 6 |
| AcetaminophenAlso: paracetamolOral suspension | Drug | Period 1, Period 2, Period 5, Period 6 |
Primary outcome
Acetaminophen Pharmacokinetic (PK) Parameters: Maximum observed plasma concentration (Cmax)
Time frame: Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
To assess the effect of multiple SC doses of PF-08653944 on the plasma PK profile of acetaminophen, a marker for gastric emptying, in healthy adult participants with overweight or obesity.
Acetaminophen PK parameters: Area under the plasma concentration (AUC)
Time frame: Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
To assess the effect of multiple SC doses of PF-08653944 on the plasma PK profile of acetaminophen, a marker for gastric emptying, in healthy adult participants with overweight or obesity.
Acetaminophen PK parameters: Time to Maximum concentration (Tmax)
Time frame: Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
1 secondary outcome
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: First dose through study completion, approximately 11 Weeks post last dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- 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-08653944 and Acetaminophen in people with Obesity and Overweight and/or 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 4 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: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Acetaminophen Pharmacokinetic (PK) Parameters: Maximum observed plasma concentration (Cmax) (time frame: Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.). The study lists 3 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 9 Jul 2026.