This study investigates the efficacy and safety of once weekly injectable MET097 in adult participants with obesity or overweight with weight-related comorbidities excluding T2D. This trial will last for a duration of 84 weeks. The primary endpoint will be assessed after 64 weeks of treatment with the secondary at 84 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
3,578
Percent change from baseline in body weight
Time frame: Baseline (Day 0) to Week 64
Percentage of Participants who achieve ≥5% of reduction from baseline body weight
Time frame: Baseline (Day 0) to Week 64
Percentage of Participants who achieve ≥10% of reduction from baseline body weight
Time frame: Baseline (Day 0) to Week 64
Percentage of Participants who achieve ≥15% of reduction from baseline body weight
Time frame: Baseline (Day 0) to Week 64
Percentage of Participants who achieve ≥20% of reduction from baseline body weight
Time frame: Baseline (Day 0) to Week 64
Change from baseline in Fasting triglycerides
Time frame: Baseline (Day 0) to Week 64
Change from baseline in non-high-density lipoprotein-cholesterol (non-HDL-C) (mg/dL)
Time frame: Baseline (Day 0) to Week 64
Change from baseline in systolic blood pressure
Time frame: Baseline (Day 0) to Week 64
Change from baseline in the Short Form 36 health survey (SF-36) physical function domain score
Time frame: Baseline (Day 0) to Week 64
Change from baseline in body weight
Time frame: Baseline (Day 0) to Week 84
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Percentage of Participants who achieve ≥5% of reduction from baseline body weight
Time frame: Baseline (Day 0) to Week 84
Percentage of Participants who achieve ≥10% of reduction from baseline body weight
Time frame: Baseline (Day 0) to Week 84
Percentage of Participants who achieve ≥15% of reduction from baseline body weight
Time frame: Baseline (Day 0) to Week 84
Percentage of Participants who achieve ≥20% of reduction from baseline body weight
Time frame: Baseline (Day 0) to Week 84
Change from baseline in Fasting triglycerides
Time frame: Baseline (Day 0) to Week 84
Change from baseline in non-high-density lipoprotein-cholesterol (non-HDL-C)
Time frame: Baseline (Day 0) to Week 84
Change from baseline in systolic blood pressure (mmHg)
Time frame: Baseline (Day 0) to Week 84
Change from baseline in the Short Form 36 health survey (SF-36) physical function domain score
Time frame: Baseline (Day 0) to Week 84
Change from baseline in waist circumference (cm)
Time frame: Baseline (Day 0) to Week 64 and Week 84
Change from baseline in glycated hemoglobin (HbA1c)
Time frame: Baseline (Day 0) to Week 64 and Week 84
Change from baseline in fasting plasma glucose (FPG)
Time frame: Baseline (Day 0) to Week 64 and Week 84
Change from baseline in fasting insulin
Time frame: Baseline (Day 0) to Week 64 and Week 84
Change from baseline in total cholesterol
Time frame: Baseline (Day 0) to Week 64 and Week 84
Change from baseline in low-density lipoprotein-cholesterol (LDL-C)
Time frame: Baseline (Day 0) to Week 64 and Week 84
Change from baseline in very low-density lipoprotein-cholesterol (VLDL-C)
Time frame: Baseline (Day 0) to Week 64 and Week 84
Change from baseline in high-density lipoprotein-cholesterol (HDL-C)
Time frame: Baseline (Day 0) to Week 64 and Week 84
Change from baseline in DBP
Time frame: Baseline (Day 0) to Week 64 and Week 84
Percent change from baseline in high-sensitivity C-reactive protein (hs-CRP)
Time frame: Baseline (Day 0) to Week 64 and Week 84
Change from baseline in EuroQoL 5-Dimension 5-Level (EQ5D-5L)
Time frame: Baseline (Day 0) to Week 64 and Week 84
Change from baseline in Control of Eating Questionnaire (CoEQ)
Time frame: Baseline (Day 0) to Week 64 and Week 84
Change from baseline in Food Noise Questionnaire (FNQ)
Time frame: Baseline (Day 0) to Week 64 and Week 84
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Week 84
Number of Participants with Serious adverse events (SAEs)
Time frame: Week 84
Number of Participants with Adverse Events of Clinical Interest (AECIs
Time frame: Week 84
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Week 84
Number of participants with anti-drug antibodies (ADAs)
Time frame: Week 84
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of PF-08653944
Time frame: Week 84
Change from baseline in body weight
Time frame: Baseline (Day 0) to Week 64
Percent change from baseline in body weight
Time frame: Baseline (Day 0) to Week 84