Overweight and/or ObesityPhase 1NCT07876518
A Study to Learn How Different Amounts of the Study Medicine Called PF-08656795 Are Tolerated and Act in Adults With Overweight or Obesity
A Phase 1 study testing PF-08656795 in people with Overweight and/or Obesity, run by Pfizer.
Trial summary
This study will look at how different amounts of the study medicine, called PF-08656795, are tolerated and act in adults with overweight or obesity. Doctors will check if each person meets the study conditions, including age, body weight, and general health. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and/or Obesity
- What is being tested?
- PF-08656795
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 16 Nov 2028
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) ≥25 to ≤40 kg/m2; with stable body weight for ≥3 months prior to screening.
- Participants are generally otherwise healthy but may have mild chronic conditions (eg, dyslipidemia or hypertension)
Who cannot join
- Individuals with clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurological, or allergic disease, are not eligible to participate.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: AN INTERVENTIONAL PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO INVESTIGATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE ASCENDING DOSES OF PF-08656795 IN ADULTS WITH OVERWEIGHT OR OBESITY
This study will look at how different amounts of the study medicine, called PF-08656795, are tolerated and act in adults with overweight or obesity.
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.
Read more
The study is seeking participants who are:
- adults, 18 to 70 years of age (inclusive)
- have a body mass index (BMI) equal to, or more than 25 kilograms/meter square (kg/m2) up to 40 kg/m2.
- limited mild, stable long-term medical conditions are allowed as assessed by the study doctor.
People who want to join the study will first go through a screening period of up to 4 weeks. The study will look at how the study medicine is tolerated, including whether participants have any reactions. It will assess how they feel after receiving multiple doses. It will also measure the amounts of study medicine in the blood and urine over time.
Participants will take part in this study for about 24 to 40 weeks including treatment and follow-up period after the final dose. Treatment duration may vary depending on their assigned group.
- Conditions
- Overweight and/or Obesity
- Being tested
- Placebo, PF-08656795
- Keywords
- overweight, obesity
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Given subcutaneously (under the skin).
PF-08656795Drug
Given subcutaneously (under the skin).
| Study group | Role | What they receive |
|---|---|---|
| PF-08656795 | Experimental | Participants will receive PF-08656795 once a month or less frequently Receives: Drug: PF-08656795 |
| Placebo | Experimental | Participants will receive placebo once a month or less frequently 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 (TEAEs)
Measured: Up to 12 weeks after last dose
Secondary outcomes (2)
Area Under the Curve from Time Zero to to time tau (AUCtau)
Measured: 0 (pre-dose), 2, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672 hours post-dose
Maximum Observed Concentration (Cmax)
Measured: 0 (pre-dose), 2, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672 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 posted15 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion16 Nov 2028 (estimated)
- Study completion16 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and/or 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
- 150 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
- NCT07876518
- Sponsor's protocol ID
- C6541002
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 Oct 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN INTERVENTIONAL PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO INVESTIGATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE ASCENDING DOSES OF PF-08656795 IN ADULTS WITH OVERWEIGHT OR OBESITY
- ClinicalTrials.gov ID
- NCT07876518
- Acronym / sponsor ID
- C6541002
- Conditions
- Overweight and/or Obesity
- Keywords
- overweight, obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 16 Nov 2028 (estimated)
- Study completion
- 16 Nov 2028 (estimated)
- First posted
- 15 Oct 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 how different amounts of the study medicine, called PF-08656795, are tolerated and act in adults with overweight or obesity.
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.
The study is seeking participants who are:
- adults, 18 to 70 years of age (inclusive)
- have a body mass index (BMI) equal to, or more than 25 kilograms/meter square (kg/m2) up to 40 kg/m2.
- limited mild, stable long-term medical conditions are allowed as assessed by the study doctor.
People who want to join the study will first go through a screening period of up to 4 weeks. The study will look at how the study medicine is tolerated, including whether participants have any reactions. It will assess how they feel after receiving multiple doses. It will also measure the amounts of study medicine in the blood and urine over time.
Participants will take part in this study for about 24 to 40 weeks including treatment and follow-up period after the final dose. Treatment duration may vary depending on their assigned group.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-08656795 | Experimental | Drug: PF-08656795Participants will receive PF-08656795 once a month or less frequently |
| Placebo | Experimental | Drug: PlaceboParticipants will receive placebo once a month or less frequently |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) ≥25 to ≤40 kg/m2; with stable body weight for ≥3 months 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 clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurological, or allergic disease, 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 |
|---|---|---|
| PlaceboGiven subcutaneously (under the skin). | Drug | Placebo |
| PF-08656795Given subcutaneously (under the skin). | Drug | PF-08656795 |
Primary outcome
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 12 weeks after last dose
2 secondary outcomes
Area Under the Curve from Time Zero to to time tau (AUCtau)
Time frame: 0 (pre-dose), 2, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672 hours post-dose
Maximum Observed Concentration (Cmax)
Time frame: 0 (pre-dose), 2, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672 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 15 Oct 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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-08656795 in people with Overweight and/or Obesity, run by Pfizer.
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: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 (TEAEs) (time frame: Up to 12 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 15 Oct 2026.