Obesity and Overweight
Conditions
Brief summary
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.
Interventions
DRUGMET097
Once-weekly MET097 administered via subcutaneous injection
DRUGPlacebo
Once-weekly placebo administered via subcutaneous injection
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* BMI ≥ 30 kg/m2 or BMI ≥ 27.0 kg/m2 to \<30.0 kg/m2 and presence of at least 1 of the following weight- related comorbidities: Hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease)
Exclusion criteria
* Have any form of diabetes * Have a self-reported body weight change \> 5 kg (11 pounds) within 3 months prior to Screening * Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) * History of chronic pancreatitis or presence of acute pancreatitis within the past 180 days prior to the Screening visit; or active/current, symptomatic gallbladder disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in body weight | Baseline (Day 0) to Week 64 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants who achieve ≥5% of reduction from baseline body weight | Baseline (Day 0) to Week 64 |
| Percentage of Participants who achieve ≥10% of reduction from baseline body weight | Baseline (Day 0) to Week 64 |
| Percentage of Participants who achieve ≥15% of reduction from baseline body weight | Baseline (Day 0) to Week 64 |
| Percentage of Participants who achieve ≥20% of reduction from baseline body weight | Baseline (Day 0) to Week 64 |
| Change from baseline in Fasting triglycerides | Baseline (Day 0) to Week 64 |
| Change from baseline in non-high-density lipoprotein-cholesterol (non-HDL-C) (mg/dL) | Baseline (Day 0) to Week 64 |
| Change from baseline in systolic blood pressure | Baseline (Day 0) to Week 64 |
| Change from baseline in the Short Form 36 health survey (SF-36) physical function domain score | Baseline (Day 0) to Week 64 |
| Change from baseline in body weight | Baseline (Day 0) to Week 84 |
| Change from baseline in non-high-density lipoprotein-cholesterol (non-HDL-C) | Baseline (Day 0) to Week 84 |
| Change from baseline in systolic blood pressure (mmHg) | Baseline (Day 0) to Week 84 |
| Change from baseline in waist circumference (cm) | Baseline (Day 0) to Week 64 and Week 84 |
| Change from baseline in glycated hemoglobin (HbA1c) | Baseline (Day 0) to Week 64 and Week 84 |
| Change from baseline in fasting plasma glucose (FPG) | Baseline (Day 0) to Week 64 and Week 84 |
| Change from baseline in fasting insulin | Baseline (Day 0) to Week 64 and Week 84 |
| Change from baseline in total cholesterol | Baseline (Day 0) to Week 64 and Week 84 |
| Change from baseline in low-density lipoprotein-cholesterol (LDL-C) | Baseline (Day 0) to Week 64 and Week 84 |
| Change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) | Baseline (Day 0) to Week 64 and Week 84 |
| Change from baseline in high-density lipoprotein-cholesterol (HDL-C) | Baseline (Day 0) to Week 64 and Week 84 |
| Change from baseline in DBP | Baseline (Day 0) to Week 64 and Week 84 |
| Percent change from baseline in high-sensitivity C-reactive protein (hs-CRP) | Baseline (Day 0) to Week 64 and Week 84 |
| Change from baseline in EuroQoL 5-Dimension 5-Level (EQ5D-5L) | Baseline (Day 0) to Week 64 and Week 84 |
| Change from baseline in Control of Eating Questionnaire (CoEQ) | Baseline (Day 0) to Week 64 and Week 84 |
| Change from baseline in Food Noise Questionnaire (FNQ) | Baseline (Day 0) to Week 64 and Week 84 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Week 84 |
| Number of Participants with Serious adverse events (SAEs) | Week 84 |
| Number of Participants with Adverse Events of Clinical Interest (AECIs | Week 84 |
| Number of Participants With Clinical Laboratory Abnormalities | Week 84 |
| Number of participants with anti-drug antibodies (ADAs) | Week 84 |
| Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of PF-08653944 | Week 84 |
| Percent change from baseline in body weight | Baseline (Day 0) to Week 84 |
Countries
Bulgaria, Canada, Czechia, Germany, Poland, Romania, Slovakia, Spain, United Kingdom, United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed