RECRUITING

A Study of MET233 in Individuals With Obesity or Overweight

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized, Double-blind, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MET233 in Otherwise Healthy Adult Participants With Obesity or Overweight

Quick Facts

Study Start:2024-11-20
Study Completion:2026-01-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07022977

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  1. * 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
  2. * Seated blood pressure higher than 160/95 mmHg at the Screening visit
  3. * Elevated resting pulse greater than 100 beats per minute at Screening visit
  4. * Presence of clinically significant ECG abnormalities
  5. * Diagnosis of diabetes (type 1 or type 2)
  6. * Participation in a weight loss program with or without pharmacotherapy during the 3 months prior to study administration
  7. * 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).

Contacts and Locations

Study Contact

Metsera Recruiting
CONTACT
888-746-7403
clinicaltrials@metsera.com

Study Locations (Sites)

MET233 Research Site 001
Cypress, California, 90630
United States

Collaborators and Investigators

Sponsor: Metsera

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-20
Study Completion Date2026-01-03

Study Record Updates

Study Start Date2024-11-20
Study Completion Date2026-01-03

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity and Overweight