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Not yet recruitingNCT07845513Updated Sep 29, 2026

A Study to Learn About the Study Medicine Called PF-08653944 in Otherwise Healthy Chinese Adults With Overweight or Obesity

A Phase 1 interventional study of PF-08653944 in Overweight, Obesity and Healthy Adults, sponsored by Pfizer. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Overweight
  • Obesity
  • Healthy Adults

Keywords

  • Overweight
  • Obesity
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    Treatment 1

    Participants will receive a single subcutaneous (SC) dose of PF-08653944 on Day 1.

    Drug: PF-08653944

Interventions

  • DrugPF-08653944

    Solution for injection

05

What researchers measure

Primary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of PF-08653944

    Time frame: Up to 85 days

  2. PK: Maximum Observed Concentration (Cmax) of PF-08653944

    Time frame: Up to 85 days

Secondary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 85 days

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: 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.

08

Registry details

Key details

Study ID
NCT07845513
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Sep 29, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Feb 21, 2027 (estimated)
Completion
Feb 21, 2027 (estimated)
Last update
Sep 29, 2026

Study contacts

Pfizer CT.gov Call Center
Contact
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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