Efficacy and Safety of MET097 Once-Weekly in People With... | NCT07311850

ID	Type	Description
C6491007	Other Identifier	Alias Study Number
2025-523974-18-00	Registry Identifier	CTIS (EU)
VESPER-4	Other Identifier	Alias Study Number

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Dec 19, 2025Actual

Primary Completion Date

Sep 21, 2027Estimated

Completion Date

Apr 25, 2028Estimated

First Submitted Date

Dec 29, 2025

First Submission Date that Met QC Criteria

Dec 29, 2025

First Posted Date

Dec 31, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2026

Last Update Posted Date

Jul 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3,501Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MET097 Dose 1	Experimental	Participants will receive MET097 administered subcutaneously	Drug: MET097
MET097 Dose 2	Experimental	Participants will receive MET097 administered subcutaneously	Drug: MET097
MET097 Dose 3	Experimental	Participants will receive MET097 administered subcutaneously	Drug: MET097
Placebo	Placebo Comparator	Once-weekly placebo administered via subcutaneous injection	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MET097	Drug	Once-weekly MET097 administered via subcutaneous injection	MET097 Dose 1 MET097 Dose 2 MET097 Dose 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent change from baseline in body weight		Baseline (Day 0) to Week 64

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants who achieve ≥5% of reduction from baseline body weight		Baseline (Day 0) to Week 64
Percentage of Participants who achieve ≥10% of reduction from baseline body weight		Baseline (Day 0) to Week 64

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pfizer CT.gov Call Center	Contact	1-800-718-1021		ClinicalTrials.gov_Inquiries@pfizer.com

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Headlands Research	Recruiting	Scottsdale	Arizona	85260	United States
Alliance Research Institute

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

ID	Term
D009765	Obesity
D050177	Overweight

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms