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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion 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. Exclusion Criteria: * 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.

Treatments Being Tested

DRUG

MET233 and MET097

For subcutaneous administration

DRUG

Placebo

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

DRUG

MET233

For subcutaneous administration

Locations (1)

Research Site MET233/097 24-101-001
Cypress, California, United States