A PHASE 1/2A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, SINGLE AND MULTIPLE ASCENDING DOSE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MET233 CO-ADMINISTERED WITH MET097 IN ADULT PARTICIPANTS WITH OBESITY OR OVERWEIGHT INCLUDING PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS
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.
• Adult males or females aged 18 to 75 years (inclusive) at the time of screening.
• BMI ≥27.0 kg/m2 and ≤38.0 kg/m2 (inclusive) at Screening for Parts A, B, and C, and ≥30.0 kg/m2 and ≤45.0 kg/m2 (inclusive) at Screening for Parts D and E. Have a BMI ≥27.0 kg/m2 and ≤45.0 kg/m2 (inclusive) at Screening for Parts G.
• Participants must be in generally stable health, as determined by the investigator based on medical history, physical examination (including vital signs), laboratory evaluations, and electrocardiogram (ECG).
‣ Participants must have no clinically significant diseases or clinically significant findings on the physical examination (including vital signs), laboratory evaluations, and electrocardiogram (ECG).
⁃ Participants in Parts C must not have clinically significant diseases except type 2 diabetes mellitus (T2DM), sleep apnea, well-controlled hypertension, and/or dyslipidemia.
⁃ Participants in Parts E and G must not have any clinically significant diseases except hypertension, dyslipidemia, and/or a clinical diagnosis of sleep apnea.
• Willing and able to comply with all scheduled study visits, procedures, and required assessments.
• Women of childbearing potential must be willing to comply with protocol-specified contraceptive requirements and must not plan to become pregnant during the study.