A Study of MET233 in Individuals With Obesity or Overweight

NCT07022977 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: MET233-24-101C6501001
• Study Type: interventional
• Target: 120
• 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. The trial will be conducted in three parts. Part A consists of single ascending dose (SAD) cohorts of MET233 or placebo. Part B consists of multiple ascending dose (MAD) cohorts, with participants treated with five once-weekly doses of MET233 or placebo. In Part C, participants will receive once-weekly doses of MET233 or placebo for 12 weeks, followed by a single higher, potential monthly dose.

Conditions

Obesity and Overweight

Outcome Measures

Primary Outcomes (1)

• Occurrence of Treatment Emergent Adverse Events

  Part A - Baseline (Day 0) to Day 89 Part B - Baseline (Day 0) to Day 113 Part C - Baseline (Day 0) to Day 162

Secondary Outcomes (5)

• Area under the concentration versus time curve during the dosing interval (AUC(0-τ))

  Part A: Baseline (Day 0) to Day 85 Part B: Baseline (Day 0) to Day 113 Part C: Baseline (Day 0) to Day 162

• Maximum observed concentration (Cmax)

  Part A: Baseline (Day 0) to Day 85 Part B: Baseline (Day 0) to Day 113 Part C: Baseline (Day 0) to Day 162

• Time to maximum observed concentration (Tmax)

  Part A: Baseline (Day 0) to Day 85 Part B: Baseline (Day 0) to Day 113 Part C: Baseline (Day 0) to Day 162

• Elimination half-life (t1/2)

  Part A: Baseline (Day 0) to Day 85 Part B: Baseline (Day 0) to Day 113 Part C: Baseline (Day 0) to Day 162

• Percent change from baseline in body weight at the protocol-specified weekly post-baseline measurements

  Part A: Baseline (Day 0) to Day 85 Part B: Baseline (Day 0) to Day 113 Part C: Baseline (Day 0) to Day 162

Study Arms (6)

(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

Interventions

Placebo BIOLOGICAL

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

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

MET233 BIOLOGICAL

For subcutaneous administration

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

• Metsera, a wholly owned subsidiary of Pfizer: lead

Study Sites (1)

MET233 Research Site 001

Cypress, California, 90630, United States

Location

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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A (40 participants), Part B (40 participants), Part C (40 participants)

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 15, 2025
• Study Start: November 20, 2024
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-01

Locations

US (1)