This study is designed to test how well MET097, an active drug, works to treat individuals with obesity or overweight when compared to placebo. MET097 or placebo will be given to individuals weekly for 28 weeks. If an individual is assigned to MET097 they will receive one of four different dose levels. Participants who have completed the first 28 weeks may participate in an exploratory extension study.
This is a multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of four different dose levels of MET097 vs. placebo for body weight loss in adult participants with obesity or overweight (body mass index \[BMI\] 27 to 50 kg/m2, aged 18 to 70), after 28 weeks with once weekly dosing. Participants who have completed the first 28 weeks may participate in an exploratory extension study that includes less frequent dosing regimens. After the dosing period, there is an additional post-treatment follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
225
Research Site MET097 24-201-001
Anaheim, California, United States
Research Site MET097 24-201-002
Hollywood, Florida, United States
Percent change from baseline in body weight at Week 28
Evaluate the efficacy of once-weekly MET097 on body weight after 28 once-weekly doses compared to placebo.
Time frame: Baseline (Week 0) through Week 28 (Day 197)
Weight reduction (weight loss) from baseline that is ≥ 5%
Time frame: Baseline (Week 0) through Week 28 (Day 197)
Weight reduction (weight loss) from baseline that is ≥ 10%
Time frame: Baseline (Week 0) through Week 28 (Day 197)
Weight reduction (weight loss) from baseline that is ≥ 15%
Time frame: Baseline (Week 0) through Week 28 (Day 197)
Change from baseline in body weight (kg)
Time frame: Baseline (Week 0) through Week 28 (Day 197)
Change from baseline in body mass index (BMI)
Time frame: Baseline (Week 0) through Week 28 (Day 197)
Change from baseline in waist circumference
Time frame: Baseline (Week 0) through Week 28 (Day 197)
Occurrence of treatment emergent adverse events (TEAEs)
Treatment emergent adverse events include adverse events of clinical interest as well as abnormal clinical significant physical exams, laboratory findings, and 12-lead ECG measurements that meet the definition for an AE.
Time frame: Baseline (Week 0) through Week 37 (Day 265)
Minimum observed concentration (Cmin)
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Time frame: Baseline (Week 0) through Week 28 (Day 197)
Area under the concentration versus time curve during the dosing interval (AUC(0-τ))
Time frame: Baseline (Week 0) through Week 31 (Day 220)
Maximum observed concentration (Cmax)
Time frame: Baseline (Week 0) through Week 31 (Day 220)
Time to maximum concentration (Tmax)
Time frame: Baseline (Week 0) through Week 31 (Day 220)
Percent change from baseline in body weight at all protocol-specified post-baseline measurements during the exploratory extension study
Time frame: Week 28 to Week 60
Occurrence of treatment emergent adverse events (TEAEs) during the exploratory extension study
Week 28 to Week 60
Time frame: Week 28 to Week 60