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 to Evaluate MET097 for Obesity and T2DM
Plain English Summary
A Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight and T2DM is a Phase 2 clinical trial sponsored by Metsera, a wholly owned subsidiary of Pfizer studying Obesity in Diabetes, Type 2 Diabetes Mellitus (T2DM). Tests how well once-weekly MET097 works compared to placebo for weight loss and blood sugar control in adults with obesity or overweight and type 2 diabetes. For adults with a BMI of 27.0 to 50.0 kg/m2 and type 2 diabetes for at least 3 months. Participation involves weekly injections for 28 weeks and regular check-ups. Alternatives include other weight loss medications and lifestyle changes. The trial aims to enroll 133 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Eligible if BMI is 27.0 to 50.0 kg/m2, type 2 diabetes for at least 3 months, and stable body weight. Not eligible if pregnant, lactating, or have certain health conditions like kidney disease, high triglycerides, or heart issues. Age range not specified, but typically adults are included. Must not have had recent surgeries or be taking certain diabetes medications. This trial is studying Obesity in Diabetes, Type 2 Diabetes Mellitus (T2DM), so participants generally need a confirmed diagnosis.
What They're Measuring
Improvements in weight and blood sugar levels could significantly benefit patients with these conditions. The specific primary outcome measures are: Percent change from baseline in body weight at Week 28 (Day 197) (Baseline (Week 0) through Week 28 (Day 197)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial addresses the need for effective, long-acting treatments for obesity and type 2 diabetes. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Obesity in Diabetes, Type 2 Diabetes Mellitus (T2DM), where improved treatment options are needed.
Investor Insight
The large market for diabetes and obesity treatments, along with the competitive landscape, suggests a high approval probability. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if you meet the BMI and diabetes criteria. Expect weekly injections and regular check-ups during the study. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: DOUBLE
- Enrollment: 133 participants
Interventions
- DRUG: MET097 Injection — MET097 is an ultra-long-acting, fully-biased analog of human GLP-1.
- DRUG: Placebo — Sterile 0.9% (w/v) saline will be used as placebo treatment during the study.
Primary Outcomes
- Percent change from baseline in body weight at Week 28 (Day 197) (Baseline (Week 0) through Week 28 (Day 197))
Secondary Outcomes
- Weight reduction (weight loss) from baseline that is ≥ 5% (Baseline (Week 0) through Week 28 (Day 197))
- Weight reduction (weight loss) from baseline that is ≥ 10% (Baseline (Week 0) through Week 28 (Day 197))
- Weight reduction (weight loss) from baseline that is ≥ 15% (Baseline (Week 0) through Week 28 (Day 197))
- Change in glycated hemoglobin A1c (HbA1c) (Baseline (Week 0) through Week 28 (Day 197))
- Change from baseline in fasting plasma glucose (FPG) (Baseline (Week 0) through Week 28 (Day 197))
Full 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 ketoacidosis, hyperosmolar state/coma, or any other types of diabetes except T2DM) * 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 * Relevant surgical history including all bariatric or weight loss surgeries * SGLT2 inhibitors and/or metformin * Had 1 or more episodes of hypoglycemia
Trial Locations
- Research Site US-97202-001012, Chula Vista, California, United States
- Research Site US-97202-001019, Los Alamitos, California, United States
- Research Site US-97202-001021, Los Angeles, California, United States
- Research Site US-97202-001007, Riverside, California, United States
- Research Site US-97202-001024, Bradenton, Florida, United States
- Research Site 097202-001001, Hollywood, Florida, United States
- Research Site 097202-001003, Tampa, Florida, United States
- Research Site 097202-001002, Decatur, Georgia, United States
- Research Site US-97202-001009, Riverdale, Georgia, United States
- Research Site 097202-001005, Savannah, Georgia, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06897202?
NCT06897202 is a Phase 2 INTERVENTIONAL study titled "A Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight and T2DM." It is currently active, not recruiting and is sponsored by Metsera, a wholly owned subsidiary of Pfizer. The trial targets enrollment of 133 participants.
What conditions does NCT06897202 study?
This trial investigates treatments for Obesity in Diabetes, Type 2 Diabetes Mellitus (T2DM). The primary condition under study is Obesity in Diabetes.
What treatments are being tested in NCT06897202?
The interventions being studied include: MET097 Injection (DRUG), Placebo (DRUG). MET097 is an ultra-long-acting, fully-biased analog of human GLP-1.
What does Phase 2 mean for NCT06897202?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT06897202?
This trial is currently "Active, Not Recruiting." It started on 2025-03-14. The estimated completion date is 2026-03.
Who is sponsoring NCT06897202?
NCT06897202 is sponsored by Metsera, a wholly owned subsidiary of Pfizer. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06897202?
The trial aims to enroll 133 participants. The trial status is active, not recruiting.
How is NCT06897202 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs double masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT06897202?
The primary outcome measures are: Percent change from baseline in body weight at Week 28 (Day 197) (Baseline (Week 0) through Week 28 (Day 197)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06897202 being conducted?
This trial is being conducted at 20 sites, including Chula Vista, California; Los Alamitos, California; Los Angeles, California; Riverside, California and 16 more sites (United States).
Where can I find official information about NCT06897202?
The official record for NCT06897202 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06897202. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06897202 testing in simple terms?
Tests how well once-weekly MET097 works compared to placebo for weight loss and blood sugar control in adults with obesity or overweight and type 2 diabetes. For adults with a BMI of 27.0 to 50.0 kg/m2 and type 2 diabetes for at least 3 months.
Why is this trial significant?
This trial addresses the need for effective, long-acting treatments for obesity and type 2 diabetes.
What are the potential risks of participating in NCT06897202?
Potential side effects include nausea, vomiting, and diarrhea. Monitor for signs of hypoglycemia, especially if you are also taking other diabetes medications. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06897202?
Ask your doctor if you meet the BMI and diabetes criteria. Expect weekly injections and regular check-ups during the study. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06897202 signal from an investment perspective?
The large market for diabetes and obesity treatments, along with the competitive landscape, suggests a high approval probability. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participation involves weekly injections for 28 weeks and regular check-ups. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Obesity in Diabetes Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.