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NCT07725809

Overview

NCT ID: NCT07725809
Lead Sponsor: PfizerINDUSTRY
Official Title: A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, PARALLEL GROUP STUDY TO ASSESS RELATIVE BIOAVAILABILITY OF PF-08653945 WHEN ADMINISTERED ACROSS DIFFERENT INJECTION SITES IN ADULTS WITH OVERWEIGHT OR OBESITY
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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 24, 2026Actual
Start Date: Jul 23, 2026Estimated
Primary Completion Date: Jan 13, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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 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.

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-08653945, amylin or calcitonin agonists, or any excipients.

Prior participation in any study involving PF-08653945 (formerly MET233) with at least one dose received.

Study Plan

Study Type: Interventional
Phase: Phase 1
Enrollment: 57Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Pfizer CT.gov Call CenterContact
ClinicalTrials.gov_Inquiries@pfizer.com

Similar Studies

Participant Group/Arms

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