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 45 kg/m2 (inclusive), 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. For Part D, after the up to 4-week screening period, the study includes weekly and monthly (ie, every 4 weeks \[QM\]) and an approximate 11-week safety follow-up after last administration. For Part E, after the up to 4-week screening period, the study includes multiple dose QW-to-QM and an approximate 11-week safety followup after last administration. For Part G, after the up to 4-week screening period, the study includes multiple dose cohort of QW and QM and an approximate 11-week safety followup after last administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
381
Altasciences Clinical Los Angeles, Inc.
Cypress, California, United States
RECRUITINGOccurrence of treatment-emergent adverse events (TEAEs)
For Part A, B, C, D, E and G
Time frame: Part A (Baseline, Day 85), Part B (Baseline, Day 155), Part C (Baseline, Day 155), Part D (Baseline, Day 218), Part E (Baseline, Day 246), Part G (Baseline, Day 274)
Area under the concentration versus time curve extrapolated to infinity (AUCinf)
For Part A
Time frame: Part A (Baseline, Day 85)
Area under the concentration versus time curve during the dosing interval (AUCtau)
For Part B, C, D, E, and G
Time frame: Part B (Baseline, Day 155), Part C (Baseline, Day 155), Part D (Baseline, Day 218), Part E (Baseline, Day 246), Part G (Baseline, Day 274)
Minimum observed concentration (Cmin)
For Part B, C, D, E, and G
Time frame: Part B (Baseline, Day 155), Part C (Baseline, Day 155), Part D (Baseline, Day 218), Part E (Baseline, Day 246), Part G (Baseline, Day 274)
Maximum observed concentration (Cmax)
For Part A, B, C, D, E, and G
Time frame: Part A (Baseline, Day 85), Part B (Baseline, Day 155), Part C (Baseline, Day 155), Part D (Baseline, Day 218), Part E (Baseline, Day 246), Part G (Baseline, Day 274)
Time to maximum observed concentration (Tmax)
For Part A, B, C, D, E, and G
Time frame: Part A (Baseline, Day 85), Part B (Baseline, Day 155), Part C (Baseline, Day 155), Part D (Baseline, Day 218), Part E (Baseline, Day 246), Part G (Baseline, Day 274)
Part A: Percent change from baseline in body weight at Day 8
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For Part A
Time frame: Baseline, Day 8
Part A: Percent change from baseline in body weight at all other postbaseline weight measurements
For Part A
Time frame: Part A (Baseline, Day 85)
Part B and Part C: Percent change from baseline in body weight at Day 85
Time frame: Baseline, Day 85
Part B and Part C: Percent change from baseline in body weight at all other postbaseline weight measurements
Time frame: Part B and Part C (Baseline, Day 155)
Percent change from baseline in body weight at Day 106
Part B (Cohorts B4-B6) and Part C
Time frame: Baseline, Day 106
Percent change from baseline in body weight at all other postbaseline weight measurements
Part B (Cohorts B4-B6) and Part C
Time frame: Part B and Part C (Baseline through Day 155)
Percent change from baseline in body weight at Day 113 and after QM dosing regimen complete
For Part D
Time frame: Part D (Baseline, Day 113 and Day 169)
Percent change from baseline in body weight at all other postbaseline weight measurements
Part D
Time frame: Part D (Baseline through Day 218)
Percent change from baseline in body weight after QW dosing regimen complete and after QM dosing regimen complete
For Part E
Time frame: Part E (Baseline, Day 141 and Day 197)
Percent change from baseline in body weight at all other postbaseline weight measurements
For Part E
Time frame: Part E (Baseline through Day 246)
Percent change from baseline in body weight after QW dosing regimen complete and after QM dosing regimen complete
For Part G
Time frame: Part G (Baseline, Day 113 and Day 225)
Percent change from baseline in body weight at all other postbaseline weight measurements
For Part G
Time frame: Part G (Baseline through Day 274)