ObesityPhase 1NCT07731139
A Study to Learn How Different Amounts of the Study Medicine Called PF-08642534 Are Tolerated and Act in the Body of People Who Have Obesity
A Phase 1 study testing PF-08642534 in people with Obesity, run by Pfizer at 1 site in United States.
Trial summary
This study will look at a study drug called PF-08642534 in people with obesity (have too much body weight) to see: if participants can take different amounts (doses) of the study drug in a safe way and how adults with obesity tolerate it, and how the body handles the study drug (for example, how the study drug is… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- PF-08642534
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2026to 21 Apr 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) ≥30.0 and ≤40.0 kg/m², and with stable body weight prior to screening.
- Participants are generally otherwise healthy but may have mild chronic conditions (eg, dyslipidemia or hypertension)
Who cannot join
- Individuals with diabetes, significant cardiovascular, hepatic, renal, gastrointestinal, or psychiatric disorders, or conditions that may affect drug absorption or metabolism, are not eligible to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Orange County Research Center
Lake Forest, California, 92630
About this study
Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO INVESTIGATE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF MULTIPLE ASCENDING ORAL DOSES OF PF-08642534 IN ADULTS WITH OBESITY
This study will look at a study drug called PF-08642534 in people with obesity (have too much body weight) to see: if participants can take different amounts (doses) of the study drug in a safe way and how adults with obesity tolerate it, and how the body handles the study drug (for example, how the study drug is absorbed and removed from the body).
People who want to join the study will first go through a screening period of up to 4 weeks. Doctors will check if each person meets the study conditions, including age, body weight, and general health. People with certain medical conditions will not be able to take part in the study.
- Conditions
- Obesity
- Being tested
- Placebo, PF-08642534
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Participants will receive matching placebo QD
PF-08642534Drug
Participants will receive PF-08642534 QD
| Study group | Role | What they receive |
|---|---|---|
| PF-08642534 | Experimental | Participants will receive PF-08642534 QD Receives: Drug: PF-08642534 |
| Placebo | Experimental | Participants will receive matching placebo once daily (QD) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events (TEAE)
Measured: Baseline up to 8 weeks after last dose
Secondary outcomes (2)
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-08642534
Measured: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of PF-08642534
Measured: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start28 Jul 2026
- Primary completion21 Apr 2027 (estimated)
- Study completion21 Apr 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
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
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
- NCT07731139
- Sponsor's protocol ID
- C6601003
- Status last verified
- Sep 2026
- First submitted
- 24 Jul 2026
- Last updated
- 23 Sep 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO INVESTIGATE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF MULTIPLE ASCENDING ORAL DOSES OF PF-08642534 IN ADULTS WITH OBESITY
- ClinicalTrials.gov ID
- NCT07731139
- Acronym / sponsor ID
- C6601003
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2026 (actual)
- Primary completion
- 21 Apr 2027 (estimated)
- Study completion
- 21 Apr 2027 (estimated)
- First posted
- 28 Jul 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 will look at a study drug called PF-08642534 in people with obesity (have too much body weight) to see: if participants can take different amounts (doses) of the study drug in a safe way and how adults with obesity tolerate it, and how the body handles the study drug (for example, how the study drug is absorbed and removed from the body).
People who want to join the study will first go through a screening period of up to 4 weeks. Doctors will check if each person meets the study conditions, including age, body weight, and general health. People with certain medical conditions will not be able to take part in the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-08642534 | Experimental | Drug: PF-08642534Participants will receive PF-08642534 QD |
| Placebo | Experimental | Drug: PlaceboParticipants will receive matching placebo once daily (QD) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) ≥30.0 and ≤40.0 kg/m², and with stable body weight prior to screening.
- Participants are generally otherwise healthy but may have mild chronic conditions (eg, dyslipidemia or hypertension)
Key exclusion criteria (1 listed)
- Individuals with diabetes, significant cardiovascular, hepatic, renal, gastrointestinal, or psychiatric disorders, or conditions that may affect drug absorption or metabolism, are not eligible to participate.
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 |
|---|---|---|
| PlaceboParticipants will receive matching placebo QD | Drug | Placebo |
| PF-08642534Participants will receive PF-08642534 QD | Drug | PF-08642534 |
Primary outcome
Incidence of treatment emergent adverse events (TEAE)
Time frame: Baseline up to 8 weeks after last dose
2 secondary outcomes
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-08642534
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of PF-08642534
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24 hours post-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 23 Sep 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.
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-08642534 in people with 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 23 Sep 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?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment emergent adverse events (TEAE) (time frame: Baseline up to 8 weeks after last dose). 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 23 Sep 2026.