A Study of MET233 in Individuals With Obesity or Overweight

Metsera, a wholly owned subsidiary of Pfizer

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Obesity and Overweight

Treatments: Biological: MET233; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07022977

MET233-24-101

Details and patient eligibility

About

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.

Full description

This is a randomized, placebo-controlled, double-blind study designed to investigate the safety, tolerability, PK and pharmacodynamic (PD) of single and multiple ascending subcutaneous (SC) doses of MET233 in otherwise healthy adult participants with obesity or overweight (body mass index [BMI] 27.0 kg/m2 to 38.0 kg/m2, inclusive).

In Part A, approximately 40 participants will receive a single dose of MET233 at up to 5 dose levels. In Part B, approximately 40 participants will receive five weekly doses of MET233 at up to 4 dose levels. In Part C, up to 4 cohorts of 10 participants each will receive 12 weekly doses. These doses may include titration. For all cohorts in Part C, the 13th dose of MET233 administered on Day 85 may be a monthly-equivalent dose to allow evaluation of a potential to switch to a monthly dosing regimen.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 6 patient groups, including a placebo group

(Part A) MET233

Experimental group

Description:

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

Treatment:

Biological: MET233

(Part A) Placebo

Placebo Comparator group

Description:

Participants will receive a single dose of placebo

Treatment:

Biological: Placebo

(Part B) MET233

Experimental group

Description:

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

Treatment:

Biological: MET233

(Part B) Placebo

Placebo Comparator group

Description:

Participants will receive five weekly doses of placebo

Treatment:

Biological: Placebo

(Part C) MET233

Experimental group

Description:

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

Treatment:

Biological: MET233

(Part C) Placebo

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo