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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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

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.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

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.

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 groups in NCT07876518
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.

30 Oct 202616 Nov 2028

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)

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.

Interested in taking part?

Pfizer CT.gov Call Center

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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