Clinical trial NCT06897202: A Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight and T2DM
Official title: A Phase 2b, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight, and Type 2 Diabetes Mellitus (VESPER-2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Obesity in Diabetes
Type 2 Diabetes Mellitus (T2DM)
Keywords: GLP-1
Metsera
T2DM
Obesity
Overweight
Weight Loss
Lead sponsor: Metsera
Sponsor class: INDUSTRY
First posted: 2025-03-26
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to test how well once-weekly MET097 (an ultra-long-acting GLP-1 receptor agonist) works to treat adults with obesity or overweight and type 2 diabetes mellitus (T2DM) compared to placebo. MET097 or placebo will be administered to individuals via subcutaneous injection once weekly for 28 weeks. If an individual is randomly assigned to MET097 they will receive one of four different dose regimens.

Detailed description: This is a 28-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy, safety, and tolerability of four different once-weekly MET097 dosing regimens vs. placebo for body weight loss in adults (18-75 years of age) with obesity or overweight (body mass index \[BMI\] ≥27 to ≤50 kg/m2) and T2DM . After completing 28 weeks of study treatment, all participants will be followed for approximately 4 weeks after administration of the last dose of study treatment.

Eligibility criteria: Inclusion Criteria:

* BMI ≥27.0 kg/m2 to ≤50.0 kg/m2 at screening
* Type 2 diabetes mellitus (\*T2DM) for at least 3 months before screening
* Glycated hemoglobin (HbA1c) value between ≥7.0% (53.0 mmol/mol) and ≤10.5% (91.3 mmol/mol) at Screening and treated with stable therapy for at least 30 days prior to Screening/Visit 1 (diet and exercise alone or in combination with metformin monotherapy and/or SGLT-2)
* Stable body weight (increase or decrease ≤5 kg) within 3 months prior to screening

Exclusion Criteria:

* Female who is lactating or who is pregnant
* Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2
* Fasting triglycerides ≥ 5.6 mmol/L (≥500 mg/dL)
* Poorly controlled hypertension
* History of stroke
* Significant cardiovascular disease including but not limited to unstable angina or valvular heart disease or has a history of myocardial infarction, coronary artery bypass graft, percutaneous coronary artery re-vascularization, or congestive heart failure
* Diagnosis of Type 1 diabetes
* History of acute or chronic 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
* Diagnosis of Type 1 diabetes
* Relevant surgical history including all bariatric or weight loss surgeries

Primary outcomes:
measure: Percent change from baseline in body weight at Week 28 (Day 197)
timeFrame: Baseline (Week 0) through Week 28 (Day 197)
Secondary outcomes:
measure: Weight reduction (weight loss) from baseline that is ≥ 5%
timeFrame: Baseline (Week 0) through Week 28 (Day 197)
measure: Weight reduction (weight loss) from baseline that is ≥ 10%
timeFrame: Baseline (Week 0) through Week 28 (Day 197)
measure: Weight reduction (weight loss) from baseline that is ≥ 15%
timeFrame: Baseline (Week 0) through Week 28 (Day 197)
measure: Change in glycated hemoglobin A1c (HbA1c)
timeFrame: Baseline (Week 0) through Week 28 (Day 197)
measure: Change from baseline in fasting plasma glucose (FPG)
timeFrame: Baseline (Week 0) through Week 28 (Day 197)
measure: Change from baseline in fasting serum insulin
timeFrame: Baseline (Week 0) through Week 28 (Day 197)
measure: Change from baseline in C-peptide
timeFrame: Baseline (Week 0) through Week 28 (Day 197)
measure: Occurrence of HbA1c <7.0% (53.0 mmol/mol)
timeFrame: Baseline (Week 0) through Week 28 (Day 197)
measure: Occurrence of HbA1c ≤6.5% (47.5 mmol/mol)
timeFrame: Baseline (Week 0) through Week 28 (Day 197)
measure: Occurrence of HbA1c <5.7% (38.8 mmol/mol)
timeFrame: Baseline (Week 0) through Week 28 (Day 197)
measure: Occurrence of treatment-emergent adverse events (TEAEs)
timeFrame: Baseline (Week 0) through Week 31 (Day 220)
measure: Occurrence of hypoglycemia according to American Diabetes Association classifications [ADA 2024]
timeFrame: Baseline (Week 0) through Week 31 (Day 220)
measure: Occurrence of anti-drug antibodies
timeFrame: Baseline (Week 0) through Week 31 (Day 220)
measure: Change from baseline in serum albumin
timeFrame: Baseline (Week 0) through Week 31 (Day 220)
measure: Change from baseline in transthyretin [pre-albumin]
timeFrame: Baseline (Week 0) through Week 31 (Day 220)
measure: Change from baseline in high-sensitivity C-reactive Protein [hsCRP]
timeFrame: Baseline (Week 0) through Week 31 (Day 220)
measure: Characterize the minimum observed concentration (Cmin)
timeFrame: Baseline (Week 0) through Week 31 (Day 220)
measure: Characterize the maximum observed concentration (Cmax)
timeFrame: Baseline (Week 0) through Week 31 (Day 220)
measure: Characterize the area under the concentration versus time curve (AUC)
timeFrame: Baseline (Week 0) through Week 31 (Day 220)
measure: Characterize the time to maximum concentration (Tmax)
timeFrame: Baseline (Week 0) through Week 31 (Day 220)
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: Research Site 097202-001001
state: Florida
city: Tampa
country: United States
facility: Research Site 097202-001003
state: Florida
city: Decatur
country: United States
facility: Research Site 097202-001002
state: Georgia
city: Savannah
country: United States
facility: Research Site 097202-001005
state: Georgia
city: Cincinnati
country: United States
facility: Research Site 097202-001010
state: Ohio
Study officials:
References: