A Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight and T2DM
VESPER-2
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)
2 other identifiers
interventional
133
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2025
Shorter than P25 for phase_2
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2025
CompletedStudy Start
First participant enrolled
March 14, 2025
CompletedFirst Posted
Study publicly available on registry
March 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 2, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 18, 2026
CompletedApril 17, 2026
April 1, 2026
10 months
March 13, 2025
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent change from baseline in body weight at Week 28 (Day 197)
Baseline (Week 0) through Week 28 (Day 197)
Secondary Outcomes (20)
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)
- +15 more secondary outcomes
Study Arms (3)
MET097 Active with titration
EXPERIMENTALPlacebo
PLACEBO COMPARATORMET097 Active without titration
EXPERIMENTALInterventions
MET097 is an ultra-long-acting, fully-biased analog of human GLP-1.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
KUR Research
Bessemer, Alabama, 35022, United States
ProSciento, Inc.
Chula Vista, California, 91911, United States
Michael Roberts Opthamologist (Eye Exam)
Glendale, California, 91204, United States
Eye Treatment Center
Long Beach, California, 90807, United States
Collaborative Neuroscience Research, LLC
Los Alamitos, California, 90720, United States
Velocity Clinical Research, Los Angeles
Los Angeles, California, 90017, United States
Clinical Innovations, Inc dba CITrials
Riverside, California, 92506, United States
Synergy Healthcare
Bradenton, Florida, 34209, United States
Miami Eye Institute
Hollywood, Florida, 33024, United States
Research Centers of America
Hollywood, Florida, 33024, United States
ForCare Clinical Research
Tampa, Florida, 33613, United States
CenExel iResearch, LLC
Decatur, Georgia, 30030, United States
EmVenio Research Centre at PRIME Healthcare
Riverdale, Georgia, 30274, United States
CenExel iResearch, LLC
Savannah, Georgia, 31405, United States
Koch Family Medicine Clinical Research
Morton, Illinois, 61550, United States
Bioluminux Clinical Research
Naperville, Illinois, 60540, United States
EmVenio Research Centre at PRIME Healthcare
Kansas City, Kansas, 66112, United States
Eagle Eye Care
Columbia, Maryland, 21045, United States
KUR Research, LLC
Columbia, Maryland, 21045, United States
CBH Health, LLC.
Gaithersburg, Maryland, 20877, United States
Emvenio Research
Garden City, Michigan, 48135, United States
Velocity Clinical Research
Omaha, Nebraska, 68134, United States
Advocare Berlin Medical Associates
Berlin, New Jersey, 08009, United States
Hassman Research Institute
Marlton, New Jersey, 08053, United States
Onsite Clinical Solutions, LLC (Satellite site)
Charlotte, North Carolina, 28277, United States
Onsite Clinical Solutions, LLC
Charlotte, North Carolina, 28277, United States
EmVenio Research Centre at PRIME Healthcare
Farmers Branch, Texas, 75234, United States
Research Your Health
Plano, Texas, 75093, United States
Revival Research Institute, LLC
Sherman, Texas, 75092, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2025
First Posted
March 26, 2025
Study Start
March 14, 2025
Primary Completion
January 2, 2026
Study Completion
March 18, 2026
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.