OverweightPhase 1NCT07400679
A Study to Learn How the Study Medicine Called PF-08653944 is Taken up Into the Blood in Adults With Overweight or Obesity
A Phase 1 study testing PF-08653944 in people with Overweight and Obesity, run by Pfizer at 1 site in United States.
Trial summary
This study is being done to learn how the study medicine affects the body and how safe it is for people who take it. The researchers will look at a number of health tests, including blood tests such as calcitonin, amylase, and lipase, because similar medicines have sometimes caused changes in these tests. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity, Healthy
- What is being tested?
- PF-08653944
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2026to 8 Jul 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants 18 years of age or older at Screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECGs.
- BMI of 27-45 kg/m2 ; and a total body weight >50 kg (110 lb).
- For Japanese participants only: BMI of 20-45 kg/m2 and a total body weight >50 kg (110 lb) and must have 4 biological Japanese grandparents who were born in Japan.
Who cannot join
- Pregnant or breastfeeding women, or those planning pregnancy during the study.
- Clinically significant medical conditions including hematologic, renal, endocrine, pulmonary, gastrointestinal (including pancreatitis, gallbladder disease, clinically relevant gastric emptying disorders), cardiovascular, hepatic, psychiatric, neurologic, or severe allergic diseases.
- Personal or first-degree family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or suspected MTC.
- Active or recent suicidal ideation in the past year, suicidal behavior within the past 5 years, or any psychiatric condition that increases risk in the investigator's judgment.
- Clinically significant gastric emptying abnormality or chronically taking drugs that directly affect GI motility.
- Acute gastrointestinal symptoms at screening or Day -1.
- Known hypersensitivity to PF-08653944, GLP-1 receptor agonists, or any excipients.
- Prior participation in any study involving PF-08653944 (formerly MET097) with at least one dose received.
Trial locations and contacts
1 site in 1 country.
United States1 site
New Haven Clinical Research Unit
New Haven, Connecticut, 06511
About this study
Official title: A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, PARALLEL GROUP STUDY TO ASSESS RELATIVE BIOAVAILABILITY OF PF-08653944 WHEN ADMINISTERED ACROSS DIFFERENT INJECTION SITES IN ADULTS WITH OVERWEIGHT OR OBESITY
This study is being done to learn how the study medicine affects the body and how safe it is for people who take it. The researchers will look at a number of health tests, including blood tests such as calcitonin, amylase, and lipase, because similar medicines have sometimes caused changes in these tests.
This study is seeking participants who are:
Read more
- Adults who are obese or overweight with weight-related health conditions, and
- Meet health and other checks assessed by the study doctor.
The study team will give a single dose of the study treatment at the clinic to the participants. At each study visit, blood samples will be collected, vital signs will be checked, and the study team will ask about any reactions or health changes. Vital signs are basic measurements that show how well the body is working. They help the study team quickly understand a participant's overall health. These usually include body temperature, heart rate, breathing rate, and blood pressure.
The study involves multiple clinic visits at a study site over the length of the study. The information collected will help researchers understand how the study medicine works and whether it is safe.
- Conditions
- Overweight, Obesity, Healthy
- Being tested
- PF-08653944
- Keywords
- Obesity, Overweight
- 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-08653944Drug
Also called MET097
Solution for injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | Participants will receive a single subcutaneous (SC) dose of PF-08653944 on Day 1 administered to the abdomen. Receives: Drug: PF-08653944 |
| Treatment 2 | Experimental | Participants will receive a single SC dose of PF-08653944 on Day 1 administered to the thigh. Receives: Drug: PF-08653944 |
| Treatment 3 | Experimental | Participants will receive a single SC dose of PF-08653944 on Day 1 administered to the upper arm. Receives: Drug: PF-08653944 |
| Treatment 4 (Optional) | Experimental | Japanese participants will receive a single SC dose of PF-08653944 on Day 1 administered to the abdomen. Receives: Drug: PF-08653944 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of PF-08653944
To assess the relative bioavailability of SC to the thigh or upper arm compared to the abdomen
Measured: Up to 85 days
PK: Maximum Observed Concentration (Cmax) of PF-08653944
To assess the relative bioavailability of SC to the thigh or upper arm compared to the abdomen
Measured: Up to 85 days
Secondary outcomes (1)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 85 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start4 Feb 2026
- Primary completion2 Jul 2026
- Study completion8 Jul 2026
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 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
- NCT07400679
- Sponsor's protocol ID
- C6491016
- Status last verified
- Aug 2026
- First submitted
- 3 Feb 2026
- Last updated
- 17 Aug 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 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, PARALLEL GROUP STUDY TO ASSESS RELATIVE BIOAVAILABILITY OF PF-08653944 WHEN ADMINISTERED ACROSS DIFFERENT INJECTION SITES IN ADULTS WITH OVERWEIGHT OR OBESITY
- ClinicalTrials.gov ID
- NCT07400679
- Acronym / sponsor ID
- C6491016
- Conditions
- Overweight, Obesity, Healthy
- Keywords
- Obesity, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- 2 Jul 2026 (actual)
- Study completion
- 8 Jul 2026 (actual)
- First posted
- 10 Feb 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 is being done to learn how the study medicine affects the body and how safe it is for people who take it. The researchers will look at a number of health tests, including blood tests such as calcitonin, amylase, and lipase, because similar medicines have sometimes caused changes in these tests.
This study is seeking participants who are:
- Adults who are obese or overweight with weight-related health conditions, and
- Meet health and other checks assessed by the study doctor.
The study team will give a single dose of the study treatment at the clinic to the participants. At each study visit, blood samples will be collected, vital signs will be checked, and the study team will ask about any reactions or health changes. Vital signs are basic measurements that show how well the body is working. They help the study team quickly understand a participant's overall health. These usually include body temperature, heart rate, breathing rate, and blood pressure.
The study involves multiple clinic visits at a study site over the length of the study. The information collected will help researchers understand how the study medicine works and whether it is safe.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Drug: PF-08653944Participants will receive a single subcutaneous (SC) dose of PF-08653944 on Day 1 administered to the abdomen. |
| Treatment 2 | Experimental | Drug: PF-08653944Participants will receive a single SC dose of PF-08653944 on Day 1 administered to the thigh. |
| Treatment 3 | Experimental | Drug: PF-08653944Participants will receive a single SC dose of PF-08653944 on Day 1 administered to the upper arm. |
| Treatment 4 (Optional) | Experimental | Drug: PF-08653944Japanese participants will receive a single SC dose of PF-08653944 on Day 1 administered to the abdomen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants 18 years of age or older at Screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECGs.
- BMI of 27-45 kg/m2 ; and a total body weight >50 kg (110 lb).
- For Japanese participants only: BMI of 20-45 kg/m2 and a total body weight >50 kg (110 lb) and must have 4 biological Japanese grandparents who were born in Japan.
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding women, or those planning pregnancy during the study.
- Clinically significant medical conditions including hematologic, renal, endocrine, pulmonary, gastrointestinal (including pancreatitis, gallbladder disease, clinically relevant gastric emptying disorders), cardiovascular, hepatic, psychiatric, neurologic, or severe allergic diseases.
- Personal or first-degree family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or suspected MTC.
- Active or recent suicidal ideation in the past year, suicidal behavior within the past 5 years, or any psychiatric condition that increases risk in the investigator's judgment.
- Clinically significant gastric emptying abnormality or chronically taking drugs that directly affect GI motility.
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: MET097Solution for injection | Drug | Treatment 1, Treatment 2, Treatment 3, Treatment 4 (Optional) |
Primary outcome
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of PF-08653944
Time frame: Up to 85 days
To assess the relative bioavailability of SC to the thigh or upper arm compared to the abdomen
PK: Maximum Observed Concentration (Cmax) of PF-08653944
Time frame: Up to 85 days
To assess the relative bioavailability of SC to the thigh or upper arm compared to the abdomen
1 secondary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 85 Days
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 17 Aug 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 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 8 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 17 Aug 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?
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?
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of PF-08653944 (time frame: Up to 85 days). The study lists 2 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 17 Aug 2026.