The goal of this Phase 1/2 clinical trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of once-weekly subcutaneous injections of MET097 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 MET097 or placebo. Part B consists of multiple ascending dose (MAD) cohorts, with participants treated with five once-weekly doses of MET097 or placebo. In Part C, participants will receive once-weekly doses of MET097 or placebo for 12 weeks, followed by a single dose at 2X or 4X to explore the potential for once-monthly dosing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Participants will receive 13 once-weekly subcutaneous injections of MET097 as follows: * 12 once-weekly doses of 0.6mg followed by a 13th dose of 1.2mg * 12 once-weekly doses of 0.6mg followed by a 13th dose of 2.4 mg * 12 once-weekly doses of 0.8 mg followed by a 13th dose of 1.6 mg * 12 once-weekly doses of 0.8 mg followed by a 13th dose of 3.2 mg * 12 once-weekly doses of 1.0 mg followed by a 13th dose of 2.0 mg * 12 once-weekly doses of 1.0 mg followed by a 13th dose of 4.0 mg * 12 once-weekly doses of 1.2 mg followed by a 13th dose of 2.4 mg * 12 once-weekly doses of 1.2 mg followed by a 13th dose of 4.8 mg * Titration regimen of 0.4mg/0.8mg/1.2mg with 4 doses at each dose-level, followed by a 13th dose of 2.4mg * Titration regimen of 0.4mg/0.8mg/1.2mg with 4 doses at each dose-level, followed by a 13th dose of 4.8mg
Participants will receive 13 once-weekly subcutaneous injections of matching placebo
Research Site MET097 23-101-002
Anaheim, California, United States
Research Site MET097 23-101-003
Cypress, California, United States
Research Site MET097 23-101-001
Overland Park, Kansas, United States
(Part C) Percent change from baseline in body weight at Week 12 (Day 85).
Time frame: Day 1 (Week 0) to Day 85 (Week 12)
(Part C) To characterize the maximum observed concentration (Cmax).
Time frame: Day 1 (Week 0) to Day 160 (Week 31)
(Part C) To characterize the time of maximum observed concentration (Tmax).
Time frame: Day 1 (Week 0) to Day 160 (Week 31)
(Part C) To characterize the area under the concentration versus time curve (AUC).
Time frame: Day 1 (Week 0) to Day 160 (Week 31)
(Part C) To characterize the elimination half-life (t1/2).
Time frame: Day 1 (Week 0) to Day 160 (Week 31)
(Part C) Occurrence of treatment-emergent adverse events (TEAEs) through Week 12.
Time frame: Day 1 (Week 0) to Day 85 (Week 12)
(Part C) Occurrence of TEAEs following the 13th dose.
Time frame: Day 85 (Week 12) to Day 160 (Week 31)
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