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

NCT07845513 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: C6491019
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Overweight; Obesity; Healthy Adults

Keywords

Overweight; Obesity

Outcome Measures

Primary Outcomes (2)

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

  Up to 85 days

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

  Up to 85 days

Secondary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  Up to 85 days

Study Arms (1)

Treatment 1

EXPERIMENTAL

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

Drug: PF-08653944

Interventions

PF-08653944 DRUG

Solution for injection

Treatment 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 29, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): February 21, 2027
• Study Completion (Estimated): February 21, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share