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
Pfizer
Summary
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.
Description
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 administ…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 significa…
Interventions
- DrugMET233 and MET097
For subcutaneous administration
- OtherPlacebo
Sterile 0.9% (w/v) saline for subcutaneous administration.
- DrugMET097
For subcutaneous administration
Location
- Altasciences Clinical Los Angeles, Inc.Cypress, California