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.
This is a randomized, placebo-controlled, double-blind, double-dummy study to investigate the safety, tolerability, PK, and PD of subcutaneous (SC) doses of MET233 co-administered with MET097 in adult participants with a BMI of 27 to 38 kg/m2, including some participants with T2DM. For Part A, after the up to 4-week screening period, the study includes 1 dose and a 12-week safety follow-up after administration. For Part B and Part C, after the up to 4-week screening period, the study includes 12 once-weekly doses and an approximately 11-week safety follow-up after the last administration. Parts A and B will include only participants with overweight or obesity without type 2 diabetes. Part C will include participants with overweight or obesity who also have type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
132
Research Site MET233/097 24-101-001
Cypress, California, United States
RECRUITINGPart A: Occurrence of treatment-emergent adverse events (TEAEs)
Time frame: Baseline (Week 0) to Day 85 (Week 12)
Part B: Occurrence of treatment-emergent adverse events (TEAEs)
Time frame: Baseline (Week 0) to Day 155 (Week 22)
Part C: Occurrence of treatment-emergent adverse events (TEAEs)
Time frame: Baseline (Week 0) to Day 155 (Week 22)
Part A: Maximum observed concentration (Cmax)
Time frame: Baseline (Week 0 ) through Day 85 (Week 12)
Part B: Maximum observed concentration (Cmax)
Time frame: Baseline (Week 0 ) through Day 155 (Week 22)
Part C: Maximum observed concentration (Cmax)
Time frame: Baseline (Week 0 ) through Day 155 (Week 22)
Part A: Area under the concentration versus time curve (AUC)
Time frame: Baseline (Week 0 ) through Day 85 (Week 12)
Part B: Area under the concentration versus time curve (AUC)
Time frame: Baseline (Week 0 ) through Day 155 (Week 22)
Part C: Area under the concentration versus time curve (AUC)
Time frame: Baseline (Week 0 ) through Day 155 (Week 22)
Part A: Time to maximum observed concentration (Tmax)
Time frame: Baseline (Week 0 ) through Day 85 (Week 12)
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Part B: Time to maximum observed concentration (Tmax)
Time frame: Baseline (Week 0 ) through Day 155 (Week 22)
Part C: Time to maximum observed concentration (Tmax)
Time frame: Baseline (Week 0 ) through Day 155 (Week 22)
Part A: Minimum observed concentration (Cmin)
Time frame: Baseline (Week 0 ) through Day 85 (Week 12)
Part B: Minimum observed concentration (Cmin)
Time frame: Baseline (Week 0 ) through Day 155 (Week 22)
Part C: Minimum observed concentration (Cmin)
Time frame: Baseline (Week 0 ) through Day 155 (Week 22)
Part A: Percent change from baseline in body weight
Time frame: Weekly post-baseline up to Day 85 (Week 12)
Part B: Percent change from baseline in body weight
Time frame: Weekly post-baseline up to Day 155 (Week 22)
Part C: Percent change from baseline in body weight
Time frame: Weekly post-baseline up to Day 155 (Week 22)