A Study of MET233 in Individuals With Obesity or Overweight

NCT07022977 | Completed Phase 1 FDA Drug

• 2 other identifiers: MET233-24-101C6501001
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-weekly subcutaneous injections of MET233 in otherwise healthy adults with overweight or obesity. This study will be conducted in four parts:

• Part A will evaluate single ascending doses of MET233 or placebo.
• Part B will evaluate multiple ascending doses, with participants receiving five once-weekly doses of MET233 or placebo.
• Part C will evaluate once-weekly dosing of MET233 or placebo for 12 weeks, followed by a single higher, potential monthly dose.
• Part D will evaluate a longer dosing schedule, in which participants will receive twelve once-weekly doses, followed by three monthly doses of MET233 or placebo. Participants in this part will be followed for 14 weeks after the final dose.

Conditions

Obesity and Overweight

Outcome Measures

Primary Outcomes (1)

• Occurrence of Treatment Emergent Adverse Events

  Part A (Baseline to Day 85), Part B (Baseline to Day 113), Part C (Baseline to Day 162), Part D (Baseline to Day 239)

Secondary Outcomes (6)

• Area under the concentration versus time curve extrapolated to infinity (AUCinf)

  Part A (Baseline to Day 85)

• Area under the concentration versus time curve during the dosing interval (AUCtau)

  Part B (Baseline to Day 113), Part C (Baseline to Day 162), Part D (Baseline to Day 239)

• Maximum observed concentration (Cmax)

  Part A (Baseline to Day 85), Part B (Baseline to Day 113), Part C (Baseline to Day 162), Part D (Baseline to Day 239)

• Time to maximum observed concentration (Tmax)

  Part A (Baseline to Day 85), Part B (Baseline to Day 113), Part C (Baseline to Day 162), Part D (Baseline to Day 239)

• Elimination half-life (t1/2)

  Part A (Baseline to Day 85), Part B (Baseline to Day 113), Part C (Baseline to Day 162), Part D (Baseline to Day 239)

Study Arms (8)

(Part A) MET233

EXPERIMENTAL

Participants will receive a single dose of MET233 at up to 5 dose levels

Biological: MET233

(Part A) Placebo

PLACEBO COMPARATOR

Participants will receive a single dose of placebo

Biological: Placebo

(Part B) MET233

EXPERIMENTAL

Participants will receive five weekly doses of MET233 at up to 4 dose levels

Biological: MET233

(Part B) Placebo

PLACEBO COMPARATOR

Participants will receive five weekly doses of placebo

Biological: Placebo

(Part C) MET233

EXPERIMENTAL

Participants will receive twelve weekly doses of MET233 at up to 4 dose levels, followed by a 13th potential monthly dose

Biological: MET233

(Part C) Placebo

PLACEBO COMPARATOR

Participants will receive twelve weekly doses of placebo, followed by a 13th potential monthly dose

Biological: Placebo

(Part D) MET233

EXPERIMENTAL

Participants will receive twelve weekly doses of MET233, followed by three monthly doses.

Biological: MET233

(Part D) Placebo

PLACEBO COMPARATOR

Participants will receive twelve weekly doses of placebo, followed by three monthly doses.

Biological: Placebo

Interventions

Placebo BIOLOGICAL

Sterile 0.9% (w/v) saline for subcutaneous administration

(Part A) Placebo; (Part B) Placebo; (Part C) Placebo; (Part D) Placebo

MET233 BIOLOGICAL

For subcutaneous administration

(Part A) MET233; (Part B) MET233; (Part C) MET233; (Part D) MET233

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥18 to ≤70 years) male and female participants with obesity or overweight (BMI 27.0 kg/m2 to 38.0 kg/m2, inclusive) but otherwise healthy.

You may not qualify if:

• Female who is lactating or who is pregnant according to the pregnancy test at the Screening visit or prior to the first study drug administration
• Seated blood pressure higher than 160/95 mmHg at the Screening visit
• Elevated resting pulse greater than 100 beats per minute at Screening visit
• Presence of clinically significant ECG abnormalities
• Diagnosis of diabetes (type 1 or type 2)
• Participation in a weight loss program with or without pharmacotherapy during the 3 months prior to study administration
• Obesity induced by endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., Melanocortin 4 Receptor deficiency or Prader-Willi Syndrome).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Altasciences Clinical Los Angeles, Inc.

Cypress, California, 90630, United States

Location

Related Links

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

MeSH Terms

Conditions

Obesity; Overweight

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 15, 2025
• Study Start: November 6, 2024
• Primary Completion: April 21, 2026
• Study Completion: April 21, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)