A Phase 2b Study to Examine the Safety and Efficacy of Once-Weekly MET097 in Adults With Obesity or Overweight

Pfizer239 enrolled

Overview

This study is designed to test how well MET097, an active drug, works to treat individuals with obesity or overweight when compared to placebo. MET097 or placebo will be given to individuals weekly for 28 weeks. If an individual is assigned to MET097 they will receive one of four different dose levels. Participants who have completed the first 28 weeks may participate in an exploratory extension study.

This is a multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of four different dose levels of MET097 vs. placebo for body weight loss in adult participants with obesity or overweight (body mass index \[BMI\] 27 to 50 kg/m2, aged 18 to 70), after 28 weeks with once weekly dosing. Participants who have completed the first 28 weeks may participate in an exploratory extension study that includes less frequent dosing regimens. After the dosing period, there is an additional post-treatment follow-up period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

239

Conditions

Obesity Overweight or Obesity

Interventions

MET097DRUG

MET097 is an ultra-long-acting, fully-biased analog of human GLP-1.

PlaceboDRUG

Sterile 0.9% (w/v) saline will be used as placebo treatment during the study.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Body mass index (BMI) at Screening of: * BMI ≥30 kg/m2 and ≤50.0 kg/m2 (can have the weight-related co-morbidities listed below) * BMI ≥27.0 kg/m2 to \<30.0 kg/m2 with at least one of the following weight-related co-morbidities: 1. Hypertension: on blood pressure (BP)-lowering medication or having systolic BP ≥130 mmHg or diastolic BP ≥80 mmHg at Screening 2. Dyslipidemia: on lipid-lowering medication or having low-density lipoprotein cholesterol (LDL-C) ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7 mmol/L), or high-density lipoprotein-cholesterol (HDL-C) \<40 mg/dL (1.0 mmol/L) for men or HDL-C \<50 mg/dL (1.3 mmol/L) for women at Screening Stable body weight (increase or decrease ≤5 kg) within 3 months prior to Screening Exclusion Criteria: * Diagnosis of diabetes (T1DM or T2DM) or glycated hemoglobin A1c (HbA1c) ≥ 6.5% or fasting plasma glucose \>125 mg/dL. * Estimated glomerular filtration rate (eGFR) \<75 mL/min/1.73 m2 * History of pancreatitis * Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) * History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years * Any lifetime history of a suicide attempt.

Locations (2)

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Research Centers of America

Hollywood, Florida, United States

Outcomes

Primary Outcomes

Percent Change From Baseline in Body Weight at Week 28: Part A

Analysis was performed using mixed model for repeated measures (MMRM) with treatment group, visit, and treatment by visit interaction, sex, and baseline body weight as fixed effects using unstructured covariance. The analysis excluded weight measurements after protocol specified intercurrent events (ICEs) including permanent treatment discontinuation, non-compliance to treatment and lifestyle change.

Time frame: Baseline (last non-missing measurement prior to the first dose), Week 28

Secondary Outcomes

Percent Change From Baseline in Body Weight at Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141 and 169: Part A

Analysis was performed using MMRM with treatment group, visit, and treatment by visit interaction, sex, and baseline body weight as fixed effects using unstructured covariance excluding weight measurements after protocol specified intercurrent ICEs.

Time frame: Baseline, Day 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141 and 169

Number of Participants With Reduction in Body Weight Greater Than or Equal to (>=) 5 Percent (%) From Baseline at Week 28: Part A

Time frame: Baseline, Week 28

Number of Participants With Reduction in Body Weight >= 10 % From Baseline at Week 28: Part A

Time frame: Baseline, Week 28

Number of Participants With Reduction in Body Weight >= 15 % From Baseline at Week 28: Part A

Time frame: Baseline, Week 28

Change From Baseline in Body Weight at Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197: Part A

Time frame: Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197

Data from ClinicalTrials.gov

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Change From Baseline in Body Mass Index (BMI) at Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197: Part A

BMI was derived from body weight in kilograms (kg) and height in meters (m), and it was calculated as weight divided by height\^2.

Time frame: Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197

Change From Baseline in Waist Circumference at Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197: Part A

Time frame: Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197

Number of Participants With Gastrointestinal (GI) Adverse Event of Clinical Interest (AECI): Part A

An adverse event (AE) was defined as any untoward medical occurrence in a participant administered an investigational product and which did not necessarily have a causal relationship with the treatment. Gastrointestinal AECIs included nausea, vomiting and diarrhea.

Time frame: From Day 1 of dosing up to 28 days after last dose for Part A

Number of Participants With Treatment Related Gastrointestinal AECIs: Part A

Time frame: From Day 1 of dosing up to 28 days after last dose for Part A

Number of Participants With Gastrointestinal AECI and Treatment Related AECIs by Severity: Part A

An AE was defined as any untoward medical occurrence in a participant administered an investigational product and which did not necessarily have a causal relationship with the treatment. Gastrointestinal AECIs included nausea, vomiting and diarrhea. Treatment related GI AECIs were GI AECIs that were related to study drug and relatedness was judged by investigator. Severity was assessed as mild: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; moderate: minimal, local or non-invasive intervention indicated, limiting age-appropriate instrumental activities of daily living and severe: medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care activities of daily living or life-threatening consequences, urgent intervention indicated or death related to an AE.

Time frame: From Day 1 of dosing up to 28 days after last dose for Part A

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs: Part A

An AE was defined as any untoward medical occurrence in a participant administered an investigational product and which does not necessarily have a causal relationship with the treatment. A TEAE was defined as any AE which on or after exposure to study treatment. Treatment related TEAEs were TEAEs that were related to study drug and relatedness was judged by investigator.

Time frame: Up to Week 37

Number of Participants With TEAEs and Treatment-Related TEAEs by Severity: Part A

An AE was defined as any untoward medical occurrence in participant administered an investigational product and which does not necessarily have causal relationship with treatment. A TEAE was defined as any AE which on or after exposure to study treatment up to 28 days following the last dose. Treatment related TEAEs were TEAEs that were related to study drug and relatedness was judged by investigator. Severity: mild: asymptomatic/ mild symptoms, clinical/ diagnostic observations only, intervention not indicated; moderate: minimal, local/ non-invasive intervention indicated, limiting age-appropriate instrumental activities of daily living and severe: medically significant but not immediately life-threatening, hospitalization/ prolongation of hospitalization indicated, disabling, limiting self-care activities of daily living/ life-threatening consequences, urgent intervention indicated/ death related to an AE.

Time frame: Up to Week 37

Number of Participants With Abnormal Clinically Significant Physical Examination: Part A

The physical examination included examination of the following body systems (at minimum): head and neck (including complete thyroid exam), cardiovascular, respiratory, gastrointestinal, brief neurological, and general appearance. Clinical significance will be judged by investigator.