Once-weekly MET097 for adults with overweight or obesity
Evaluating The Efficacy and Safety of MET097, a Fully-Biased, Ultra Long-Acting GLP-1RA, In People With Overweight or Obesity: A Phase 3, Multi-Center Randomized, Controlled Trial (VESPER-4)
This trial will test whether a once-weekly injection called MET097 helps adults with obesity or overweight (without diabetes) lose weight and is safe.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 3500 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 196 sites (Scottsdale, Arizona and 195 other locations) |
| Trial ID | NCT07311850 on ClinicalTrials.gov |
What this trial studies
Adults meeting BMI criteria (≥30 kg/m2, or 27–<30 kg/m2 with at least one weight-related comorbidity) will receive either once-weekly injectable MET097 or matching placebo for up to 84 weeks. The primary efficacy endpoint is measured after 64 weeks of treatment, with additional assessments at 84 weeks and safety monitoring throughout. Key exclusions include any form of diabetes, recent large weight change, personal or family history of medullary thyroid carcinoma or MEN-2, recent pancreatitis, or active symptomatic gallbladder disease. The trial is conducted at multiple clinical research sites in the United States and collects both weight and safety outcome data.
Who should consider this trial
Good fit: Adults with BMI ≥30 kg/m2 or BMI 27.0–<30.0 kg/m2 plus at least one weight-related comorbidity (hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease) who do not have diabetes and meet other screening requirements are ideal candidates.
Not a fit: People with any form of diabetes, recent large weight changes, a personal or family history of medullary thyroid carcinoma or MEN-2, recent pancreatitis, or active symptomatic gallbladder disease are not likely to be eligible or benefit from participation.
Why it matters
Potential benefit: If successful, MET097 could offer an effective once-weekly injectable option to help people with obesity or overweight lose clinically meaningful weight and improve weight-related health problems.
How similar studies have performed: Other once-weekly injectable medications for weight management (for example GLP-1 receptor agonists) have shown substantial weight loss in similar populations, so this approach builds on earlier successful therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * BMI ≥ 30 kg/m2 or BMI ≥ 27.0 kg/m2 to \<30.0 kg/m2 and presence of at least 1 of the following weight- related comorbidities: Hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease) Exclusion Criteria: * Have any form of diabetes * Have a self-reported body weight change \> 5 kg (11 pounds) within 3 months prior to Screening * Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) * History of chronic pancreatitis or presence of acute pancreatitis within the past 180 days prior to the Screening visit; or active/current, symptomatic gallbladder disease
Where this trial is running
Scottsdale, Arizona and 195 other locations
- Headlands Research — Scottsdale, Arizona, United States (Recruiting)
- Alliance Research Institute — Canoga Park, California, United States (Recruiting)
- Clinical Innovations, Inc dba CITrials — Riverside, California, United States (Recruiting)
- Peninsula Headlands LLC — Rolling Hills, California, United States (Recruiting)
- Collaborative Neuroscience Research, LLC — Torrance, California, United States (Recruiting)
- CenExcel Rocky Mountain Clinical Research, LLC — Englewood, Colorado, United States (Recruiting)
- Research Centers of America — Hollywood, Florida, United States (Recruiting)
- Future Medical Research (Civia Health) — Longwood, Florida, United States (Recruiting)
- Advanced Clinical Research — Miami, Florida, United States (Recruiting)
- Oviedo Medical Research — Oviedo, Florida, United States (Recruiting)
- CenExel FCR - ForCare Clinical Research — Tampa, Florida, United States (Recruiting)
- DelRicht Research @ Springer Wellness and Restorative Health — Atlanta, Georgia, United States (Recruiting)
- CenExel iResearch, LLC — Savannah, Georgia, United States (Recruiting)
- CenExel CBH Health — Gaithersburg, Maryland, United States (Recruiting)
- Civia Health Shelby — Shelby, Michigan, United States (Not_yet_recruiting)
- Clinical Research Professionals — Chesterfield, Missouri, United States (Recruiting)
- Civia Health St. Louis — Creve Coeur, Missouri, United States (Not_yet_recruiting)
- Civia Health Independence — Independence, Missouri, United States (Not_yet_recruiting)
- Quality Clinical Research Inc — Omaha, Nebraska, United States (Recruiting)
- Primary Care Research (Civia Health) — Papillion, Nebraska, United States (Recruiting)
- CenExel HRI - Hassman Research Institute — Marlton, New Jersey, United States (Recruiting)
- Forum Health Cary — Cary, North Carolina, United States (Recruiting)
- Eximia EquiHealth Research — Durham, North Carolina, United States (Recruiting)
- TMA Headlands LLC — Wilmington, North Carolina, United States (Recruiting)
- Summit Headlands LLC — Portland, Oregon, United States (Recruiting)
- Tribe Clinical Research, LLC — Greenville, South Carolina, United States (Recruiting)
- Tribe Clinical Research, LLC — Spartanburg, South Carolina, United States (Recruiting)
- Civia Health Goodlettsville — Goodlettsville, Tennessee, United States (Recruiting)
- Civia Health Nashville — La Vergne, Tennessee, United States (Recruiting)
- Civia Health Memphis — Memphis, Tennessee, United States (Not_yet_recruiting)
- Forum Austin (Civia Health) — Austin, Texas, United States (Recruiting)
- Cedar Health Research — Dallas, Texas, United States (Not_yet_recruiting)
- GLRI El Paso Research — El Paso, Texas, United States (Recruiting)
- Dallas Clinical Research Center (Pillar Clinical Research) — Richardson, Texas, United States (Recruiting)
- Pantheon Clinical Research — Bountiful, Utah, United States (Recruiting)
- Cinme — Buenos Aires, Argentina (Not_yet_recruiting)
- Cedic — Buenos Aires, Argentina (Not_yet_recruiting)
- Centro Medico Viamonte — Buenos Aires, Argentina (Not_yet_recruiting)
- Clinica Privada Velez Sarsfield — Córdoba, Argentina (Not_yet_recruiting)
- Instituto de Investigaciones Clinicas Cordoba — Córdoba, Argentina (Not_yet_recruiting)
- Cidim — Córdoba, Argentina (Not_yet_recruiting)
- CIPADI - Centro Integral de Prevencion Y Atencion en Diabetes — Godoy Cruz, Argentina (Not_yet_recruiting)
- IIC Mar del Plata — Mar del Plata, Argentina (Not_yet_recruiting)
- CIAD Moron — Morón, Argentina (Not_yet_recruiting)
- Centro Medico Privado de Reumatologia — San Miguel de Tucumán, Argentina (Not_yet_recruiting)
- Instituto Medico Catamarca (IMEC) — Santa Fe, Argentina (Not_yet_recruiting)
- MHAT Botevgrad — Botevgrad, Bulgaria (Not_yet_recruiting)
- 4 Life EOOD — Burgas, Bulgaria (Not_yet_recruiting)
- Multiprofile Hospital for Active Treatment Dobrich AD (MHAT Dobrich AD) — Dobrich, Bulgaria (Not_yet_recruiting)
- Medical Center New Polyclinic Gabrovo Ltd. — Gabrovo, Bulgaria (Not_yet_recruiting)
+146 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.