OverweightPhase 1NCT07845513
A Study to Learn About the Study Medicine Called PF-08653944 in Otherwise Healthy Chinese 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 China.
Trial summary
The purpose of this study is to learn about: How PF-08653944 is changed and removed from the body after taken Safety of PF-08653944 The extent to which side effects can be tolerated after taking PF- 08653944 for the possible treatment of heart failure This study is seeking participants who: Are healthy Chinese adults… 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 Adults
- 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
- 16 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to 21 Feb 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
- 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 24-45 kg/m2; and a total body weight >50 kg (110 lb).
- Chinese participants are defined as individuals currently residing in mainland China who were born in China and have both parents of Chinese descent.
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 with at least one dose received.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 101100
About this study
Official title: A PHASE 1, OPEN-LABEL STUDY TO INVESTIGATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF PF-08653944 FOLLOWING SINGLE DOSE SUBCUTANEOUS ADMINISTRATION IN OTHERWISE HEALTHY CHINESE ADULT PARTICIPANTS WITH OVERWEIGHT OR OBESITY
The purpose of this study is to learn about:
- How PF-08653944 is changed and removed from the body after taken
- Safety of PF-08653944
- The extent to which side effects can be tolerated after taking PF- 08653944 for the possible treatment of heart failure
Read more
This study is seeking participants who:
- Are healthy Chinese adults who are aged 18 years and older
- Have body mass index of 24 - 45 kilograms/meter2
- Have a total body weight of equal to or more than 50 kilograms (110 pounds)
- Do not have prior significant medical conditions, history of drug or alcohol abuse
All participants in this study will receive a single dose of PF-08653944 at the study clinic.
The experiences of the participants receiving the study medicine will be looked at. This will help to see if the study medicine is safe.
Participants will take part in this study for around 16 weeks. During this time, they will have 6 study visits at the study clinic.
- Conditions
- Overweight, Obesity, Healthy Adults
- Being tested
- PF-08653944
- 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.
PF-08653944Drug
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. 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
Measured: Up to 85 days
PK: Maximum Observed Concentration (Cmax) of PF-08653944
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 posted29 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion21 Feb 2027 (estimated)
- Study completion21 Feb 2027 (estimated)
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
- Single group
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT07845513
- Sponsor's protocol ID
- C6491019
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 13 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL STUDY TO INVESTIGATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF PF-08653944 FOLLOWING SINGLE DOSE SUBCUTANEOUS ADMINISTRATION IN OTHERWISE HEALTHY CHINESE ADULT PARTICIPANTS WITH OVERWEIGHT OR OBESITY
- ClinicalTrials.gov ID
- NCT07845513
- Acronym / sponsor ID
- C6491019
- Conditions
- Overweight, Obesity, Healthy Adults
- Keywords
- Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 21 Feb 2027 (estimated)
- Study completion
- 21 Feb 2027 (estimated)
- First posted
- 29 Sep 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.
The purpose of this study is to learn about:
- How PF-08653944 is changed and removed from the body after taken
- Safety of PF-08653944
- The extent to which side effects can be tolerated after taking PF- 08653944 for the possible treatment of heart failure
This study is seeking participants who:
- Are healthy Chinese adults who are aged 18 years and older
- Have body mass index of 24 - 45 kilograms/meter2
- Have a total body weight of equal to or more than 50 kilograms (110 pounds)
- Do not have prior significant medical conditions, history of drug or alcohol abuse
All participants in this study will receive a single dose of PF-08653944 at the study clinic.
The experiences of the participants receiving the study medicine will be looked at. This will help to see if the study medicine is safe.
Participants will take part in this study for around 16 weeks. During this time, they will have 6 study visits at the study clinic.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Drug: PF-08653944Participants will receive a single subcutaneous (SC) dose of PF-08653944 on Day 1. |
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 24-45 kg/m2; and a total body weight >50 kg (110 lb).
- Chinese participants are defined as individuals currently residing in mainland China who were born in China and have both parents of Chinese descent.
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-08653944Solution for injection | Drug | Treatment 1 |
Primary outcome
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of PF-08653944
Time frame: Up to 85 days
PK: Maximum Observed Concentration (Cmax) of PF-08653944
Time frame: Up to 85 days
1 secondary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 85 days
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 13 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
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 China.
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: opening soon, as of the sponsor's last update on 13 Oct 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 China. 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?
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 13 Oct 2026.