RECRUITING

A Study of MET233 in Combination With MET097 in Individuals With Obesity or Overweight With or Without Diabetes

Conditions

Obesity and Obesity-related Medical Conditions GLP-1 Metsera

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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

This study is designed to test how well the combination of MET233 with MET097 works to treat individuals with obesity or overweight with or without diabetes.

Official Title

A Phase 1 Randomized, Double-Blind, Placebo Controlled. Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MET233 Co-administered With MET097 in Adult Participants With Obesity or Overweight Including Participants With Type 2 Diabetes Mellitus

Quick Facts

Study Start:2025-03-03

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06924320

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 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* BMI ≥27 kg/m2 and ≤38.0 kg/m2 (inclusive) at screening * For participants in Part A and B, no history of clinically significant diseases or clinically significant findings from the physical examination. For participants in Part C, no clinically significant diseases except T2DM, well controlled hypertension, and/or dyslipidemia. * For participants in Part C, diagnosed with T2DM for at least 3 months before screening. * For participants in Part C, T2DM includes glycated hemoglobin (HbA1c) value ≤10.5% at Screening and treated with stable therapy for at least 30 days prior to Screening/Visit 1.	* Female who is lactating or who is pregnant according to the pregnancy test at Screening or on Day 1. * Seated blood pressure higher than 160/100 mmHg at the Screening visit or prior to the first study drug administration. * Elevated resting pulse greater than 100 beats per minute at Screening visit or prior to the first study drug administration. * Estimated glomerular filtration rate (eGFR) \<80 mL/min at the Screening visit. * Diagnosis of Type 1 diabetes. * For Part A and Part B: Diagnosis of T2DM or glycated hemoglobin (HbA1c) \> 6.4% or fasting plasma glucose \>126 mg/dL at the Screening visit or history of taking any medications to lower glucose. * For Part A and Part B: Participant reported weight-related comorbidity, including sleep apnea and cardiovascular disease. * History of bariatric or weight loss surgeries. * Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome. * Lifetime history of acute or chronic pancreatitis or pancreatic cancer. * Participation in a weight loss program with or without pharmacotherapy during the 3 months prior to study administration or plans to do so.

Inclusion Criteria

Exclusion Criteria

* BMI ≥27 kg/m2 and ≤38.0 kg/m2 (inclusive) at screening
* For participants in Part A and B, no history of clinically significant diseases or clinically significant findings from the physical examination. For participants in Part C, no clinically significant diseases except T2DM, well controlled hypertension, and/or dyslipidemia.
* For participants in Part C, diagnosed with T2DM for at least 3 months before screening.
* For participants in Part C, T2DM includes glycated hemoglobin (HbA1c) value ≤10.5% at Screening and treated with stable therapy for at least 30 days prior to Screening/Visit 1.

* Female who is lactating or who is pregnant according to the pregnancy test at Screening or on Day 1.
* Seated blood pressure higher than 160/100 mmHg at the Screening visit or prior to the first study drug administration.
* Elevated resting pulse greater than 100 beats per minute at Screening visit or prior to the first study drug administration.
* Estimated glomerular filtration rate (eGFR) \<80 mL/min at the Screening visit.
* Diagnosis of Type 1 diabetes.
* For Part A and Part B: Diagnosis of T2DM or glycated hemoglobin (HbA1c) \> 6.4% or fasting plasma glucose \>126 mg/dL at the Screening visit or history of taking any medications to lower glucose.
* For Part A and Part B: Participant reported weight-related comorbidity, including sleep apnea and cardiovascular disease.
* History of bariatric or weight loss surgeries.
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome.
* Lifetime history of acute or chronic pancreatitis or pancreatic cancer.
* Participation in a weight loss program with or without pharmacotherapy during the 3 months prior to study administration or plans to do so.

Contacts and Locations

Study Contact

Metsera Recruiting

CONTACT

888-746-7403

clinicaltrials@metsera.com

Study Locations (Sites)

Research Site MET233/097 24-101-001

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 Date2025-03-03

Study Completion Date2026-01

Study Record Updates

Study Start Date2025-03-03

Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

GLP-1
Metsera

Additional Relevant MeSH Terms

Obesity and Obesity-related Medical Conditions