A Study to Learn How the Study Medicine Called PF-08653945 is Taken up Into the Blood in Adults With Overweight or Obesity

NCT07725809 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: C65010032026-526334-67-00
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to learn how the study medicine affects the body. It will also assess how safe it is for people who take it. The researchers will use blood tests to measure how much medicine is in the blood. This study is seeking adults who are:

• obese or overweight with weight-related health conditions, and
• Meet health and other checks assessed by the study doctor. The study team will give a single dose of the study treatment at the clinic to the participants. At each study visit, blood samples will be collected and vital signs will be checked. The study team will also ask about any reactions or health changes. Vital signs are basic measurements that show how well the body is working. They help the study team quickly understand a participant's overall health. These usually include body temperature, heart rate, breathing rate, and blood pressure. The study involves multiple clinic visits at a study site over the length of the study. The information collected will help researchers understand how the study medicine works and whether it is safe.

Conditions

Overweight; Obesity; Healthy

Keywords

obesity; overweight; biological availability; pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK): Area Under the Curve (AUC) of PF-08653945

  AUC is a measure of the plasma concentration of the study drug over time. It is used to characterize absorption of the drug.

  Up to 57 days post-dose

• Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of PF-08653945

  Cmax refers to the maximum observed serum concentration of the study drug.

  Up to 57 days post-dose

Secondary Outcomes (1)

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

  Up to 57 days

Study Arms (4)

Treatment A (Cohort 1)

EXPERIMENTAL

Participants will receive a single SC dose of PF 08653945 on Period 1 Day 1 administered to the abdomen.

Drug: PF-08653945

Treatment B (Cohort 1)

EXPERIMENTAL

Participants will receive a single SC dose of PF 08653945 on Period 1 Day 1 administered to the thigh.

Drug: PF-08653945

Treatment C (Cohort 1)

EXPERIMENTAL

Participants will receive a single SC dose of PF 08653945 on Period 1 Day 1 administered to the upper arm.

Drug: PF-08653945

Treatment A (Optional Cohort 2)

EXPERIMENTAL

Japanese participants will receive a single SC dose of PF 08653945 on Period 1 Day 1 administered to the abdomen.

Drug: PF-08653945

Interventions

PF-08653945 DRUG

Subcutaneous Injection

Treatment A (Cohort 1); Treatment A (Optional Cohort 2); Treatment B (Cohort 1); Treatment C (Cohort 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 27-45 kg/m2; and a total body weight \>50 kg (110 lb).
• For Japanese participants (Optional Cohort 2) only: BMI of 22-45 kg/m2 and a total body weight \>50 kg (110 lb). NOTE: Participants enrolling as Japanese must have 4 biological Japanese grandparents who were born in Japan.

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-08653945, amylin or calcitonin agonists, or any excipients.
• Prior participation in any study involving PF-08653945 (formerly MET233) with at least one dose received.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Location

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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: July 23, 2026
• Primary Completion (Estimated): January 13, 2027
• Study Completion (Estimated): January 13, 2027
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)