A Phase 2b Study to Evaluate the Efficacy and Safety of Once-Monthly MET097 in Adults With Obesity or Overweight
Purpose
This study is designed to test the weight loss effects, safety, and tolerability of multiple monthly doses of MET097 after 12 weekly doses, compared to placebo. Participants are eligible if they have overweight or obesity and do not have type 2 diabetes.
Conditions
- Obesity
- Overweight or Obesity
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 3. 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 - Poorly controlled hypertension at, defined as any of the following: - Mean seated systolic BP ≥160 mm Hg or mean seated diastolic BP ≥95 mm Hg at Screening visit - A change in antihypertensive medications within 30 days of Screening visit - Renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension at Screening; postural hypotension is defined as a sustained reduction of systolic blood pressure of at least 20 mmHg or diastolic blood pressure of 10 mmHg, with or without symptoms during the assessment, within three minutes of standing - Thyroid-stimulating hormone (TSH) level lower than 0.4 mIU/L or higher than 6.0 mIU/L at the Screening visit. Note: participants receiving treatment for hypothyroidism may be included, provided their thyroid hormone replacement dose has been stable for at least 6 months
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental MET097 |
Participants will be randomized to one of four dosing regimens receiving twelve weekly doses of MET097 (with or without titration) followed by multiple monthly doses. |
|
|
Placebo Comparator Placebo |
Participants who are randomized to the placebo arm will receive twelve weekly doses of placebo followed by multiple monthly doses. |
|
Recruiting Locations
Hollywood, Florida 33024
Tampa, Florida 33613
Decatur, Georgia 30030
Savannah, Georgia 31405
Marlton, New Jersey 08053
More Details
- NCT ID
- NCT06973720
- Status
- Recruiting
- Sponsor
- Metsera
Detailed Description
This is a multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and tolerability of multiple once monthly (QM) dose levels of MET097 after 12 once weekly (QW) doses, compared to placebo. The study will include adult participants with obesity or overweight. Participants will initially receive once weekly MET097 with or without titration or placebo for 12 weeks. Participants will then transition to a four-fold higher monthly dose for a total of 13 monthly doses. The primary endpoint is at Week 28, four weeks after the fourth monthly dose. All participants will be followed for ~5 half-lives after administration of the last dose for safety.