This study is designed to test the weight loss effects, safety, and tolerability of multiple monthly doses of MET097 after 12 weekly doses, compared to placebo. Participants are eligible if they have overweight or obesity and do not have type 2 diabetes.
This is a multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and tolerability of multiple once monthly (QM) dose levels of MET097 after 12 once weekly (QW) doses, compared to placebo. The study will include adult participants with obesity or overweight. Participants will initially receive once weekly MET097 with or without titration or placebo for 12 weeks. Participants will then transition to a four-fold higher monthly dose for a total of 13 monthly doses. The primary endpoint is at Week 28, four weeks after the fourth monthly dose. All participants will be followed for \~5 half-lives after administration of the last dose for safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
250
Research Centers of America
Hollywood, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
CenExel iResearch, LLC
Decatur, Georgia, United States
CenExel iResearch, LLC
Savannah, Georgia, United States
Percent change from baseline in body weight at Week 28
Evaluate the efficacy at Week 28 of four dose regimens of QW MET097 switching to QM compared to placebo.
Time frame: Baseline (Week 0) through Week 28 (Day 197)
Percent change from baseline in body weight at Week 64
Time frame: Baseline (Week 0) through Week 64 (Day 449)
Percent change from baseline in body weight at all other post-baseline weight measurements up to Week 64 other than Week 28
Time frame: Baseline (Week 0) through Week 24 (Day 169); Week 32 (Day 225) through Week 64 (Day 449)
Change from baseline in absolute bodyweight (in kg) at all protocol-specified weekly and monthly post-baseline measurements
Time frame: Baseline (Week 0) through Week 64 (Day 449)
Change from baseline in body mass index (BMI) at all protocol-specified weekly and monthly post-baseline measurements
Time frame: Baseline (Week 0) through Week 64 (Day 449)
Change from baseline in waist circumference (in cm) at all protocol-specified weekly and monthly post-baseline measurements
Time frame: Baseline (Week 0) through Week 64 (Day 449)
Percent change from baseline in body weight at post-treatment follow-up
Time frame: Baseline (Week 0) through Week 72 (Day 505)
Change from baseline in absolute bodyweight (in kg) at post-treatment follow-up
Time frame: Baseline (Week 0) through Week 72 (Day 505)
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Hassman Research Institute
Marlton, New Jersey, United States
Change from baseline in body mass index (BMI) at post-treatment follow-up
Time frame: Baseline (Week 0) through Week 72 (Day 505)
Change from baseline in waist circumference (in cm) at post-treatment follow-up
Time frame: Baseline (Week 0) through Week 72 (Day 505)
Occurrence of treatment emergent adverse events (TEAEs)
Time frame: Baseline (Week 0) through Week 72 (Day 505)
Minimum observed concentration (Cmin)
Time frame: Baseline (Week 0) through Week 72 (Day 505)
Area under the concentration versus time curve during the dosing interval (AUC)
Time frame: Baseline (Week 0) through Week 72 (Day 505)
Maximum observed concentration (Cmax)
Time frame: Baseline (Week 0) through Week 72 (Day 505)
Time to maximum concentration (Tmax)
Time frame: Baseline (Week 0) through Week 72 (Day 505)