The goal of this clinical trial is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-weekly subcutaneous injections of MET233 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 MET233 or placebo. Part B consists of multiple ascending dose (MAD) cohorts, with participants treated with five once-weekly doses of MET233 or placebo. In Part C, participants will receive once-weekly doses of MET233 or placebo for 12 weeks, followed by a single higher, potential monthly dose.
This is a randomized, placebo-controlled, double-blind study designed to investigate the safety, tolerability, PK and pharmacodynamic (PD) of single and multiple ascending subcutaneous (SC) doses of MET233 in otherwise healthy adult participants with obesity or overweight (body mass index \[BMI\] 27.0 kg/m2 to 38.0 kg/m2, inclusive). In Part A, approximately 40 participants will receive a single dose of MET233 at up to 5 dose levels. In Part B, approximately 40 participants will receive five weekly doses of MET233 at up to 4 dose levels. In Part C, up to 4 cohorts of 10 participants each will receive 12 weekly doses. These doses may include titration. For all cohorts in Part C, the 13th dose of MET233 administered on Day 85 may be a monthly-equivalent dose to allow evaluation of a potential to switch to a monthly dosing regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
MET233 Research Site 001
Cypress, California, United States
Occurrence of Treatment Emergent Adverse Events
Time frame: Part A - Baseline (Day 0) to Day 89 Part B - Baseline (Day 0) to Day 113 Part C - Baseline (Day 0) to Day 162
Area under the concentration versus time curve during the dosing interval (AUC(0-τ))
Time frame: Part A: Baseline (Day 0) to Day 85 Part B: Baseline (Day 0) to Day 113 Part C: Baseline (Day 0) to Day 162
Maximum observed concentration (Cmax)
Time frame: Part A: Baseline (Day 0) to Day 85 Part B: Baseline (Day 0) to Day 113 Part C: Baseline (Day 0) to Day 162
Time to maximum observed concentration (Tmax)
Time frame: Part A: Baseline (Day 0) to Day 85 Part B: Baseline (Day 0) to Day 113 Part C: Baseline (Day 0) to Day 162
Elimination half-life (t1/2)
Time frame: Part A: Baseline (Day 0) to Day 85 Part B: Baseline (Day 0) to Day 113 Part C: Baseline (Day 0) to Day 162
Percent change from baseline in body weight at the protocol-specified weekly post-baseline measurements
Time frame: Part A: Baseline (Day 0) to Day 85 Part B: Baseline (Day 0) to Day 113 Part C: Baseline (Day 0) to Day 162
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.