Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 4:40 AM
Study NCT ID:
NCT07311850
Status:
RECRUITING
Last Update Posted:
2026-02-17
First Post:
2025-12-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of MET097 Once-Weekly in People With Overweight or Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2025-12-29', 'studyFirstSubmitQcDate': '2025-12-29', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change from baseline in body weight', 'timeFrame': 'Baseline (Day 0) to Week 64'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants who achieve ≥5% of reduction from baseline body weight', 'timeFrame': 'Baseline (Day 0) to Week 64'}, {'measure': 'Percentage of Participants who achieve ≥10% of reduction from baseline body weight', 'timeFrame': 'Baseline (Day 0) to Week 64'}, {'measure': 'Percentage of Participants who achieve ≥15% of reduction from baseline body weight', 'timeFrame': 'Baseline (Day 0) to Week 64'}, {'measure': 'Percentage of Participants who achieve ≥20% of reduction from baseline body weight', 'timeFrame': 'Baseline (Day 0) to Week 64'}, {'measure': 'Change from baseline in Fasting triglycerides', 'timeFrame': 'Baseline (Day 0) to Week 64'}, {'measure': 'Change from baseline in non-high-density lipoprotein-cholesterol (non-HDL-C) (mg/dL)', 'timeFrame': 'Baseline (Day 0) to Week 64'}, {'measure': 'Change from baseline in systolic blood pressure (mmHg)', 'timeFrame': 'Baseline (Day 0) to Week 64'}, {'measure': 'Change from baseline in the Short Form 36 health survey (SF-36) physical function domain score', 'timeFrame': 'Baseline (Day 0) to Week 64'}, {'measure': 'Mean change from baseline in body weight', 'timeFrame': 'Baseline (Day 0) to Week 84'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity and Overweight']}, 'descriptionModule': {'briefSummary': 'This study investigates the efficacy and safety of once weekly injectable MET097 in adult participants with obesity or overweight with weight-related comorbidities excluding T2D. This trial will last for a duration of 84 weeks. The primary endpoint will be assessed after 64 weeks of treatment with the secondary at 84 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n\nExclusion Criteria:\n\n* Have any form of diabetes\n* Have a self-reported body weight change \\> 5 kg (11 pounds) within 3 months prior to Screening\n* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)\n* 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'}, 'identificationModule': {'nctId': 'NCT07311850', 'acronym': 'VESPER-4', 'briefTitle': 'Efficacy and Safety of MET097 Once-Weekly in People With Overweight or Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'VESPER-4 (MET097-25-301)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MET097 Dose 1', 'description': 'Participants will receive MET097 administered subcutaneously', 'interventionNames': ['Drug: MET097']}, {'type': 'EXPERIMENTAL', 'label': 'MET097 Dose 2', 'description': 'Participants will receive MET097 administered subcutaneously', 'interventionNames': ['Drug: MET097']}, {'type': 'EXPERIMENTAL', 'label': 'MET097 Dose 3', 'description': 'Participants will receive MET097 administered subcutaneously', 'interventionNames': ['Drug: MET097']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Once-weekly placebo administered via subcutaneous injection', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'MET097', 'type': 'DRUG', 'otherNames': ['PF-08653944'], 'description': 'Once-weekly MET097 administered via subcutaneous injection', 'armGroupLabels': ['MET097 Dose 1', 'MET097 Dose 2', 'MET097 Dose 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Once-weekly placebo administered via subcutaneous injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92506', 'city': 'Riverside', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site 97301-001007', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '90504', 'city': 'Torrance', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site 97301-001070', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site 97301-001077', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site 97302-001001', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '27511', 'city': 'Cary', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site 97301-001309', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}], 'centralContacts': [{'name': 'Pfizer CT.gov Call Center', 'role': 'CONTACT', 'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021'}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Metsera, a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}