Efficacy and Safety of MET097 Once-Weekly in People With Overweight or Obesity

NCT ID: NCT07311850

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

3500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-29

Study Completion Date

2028-05-31

Brief Summary

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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

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Conditions

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Obesity and Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MET097 Dose 1

Participants will receive MET097 administered subcutaneously

Group Type EXPERIMENTAL

MET097

Intervention Type DRUG

Once-weekly MET097 administered via subcutaneous injection

MET097 Dose 2

Participants will receive MET097 administered subcutaneously

Group Type EXPERIMENTAL

MET097

Intervention Type DRUG

Once-weekly MET097 administered via subcutaneous injection

MET097 Dose 3

Participants will receive MET097 administered subcutaneously

Group Type EXPERIMENTAL

MET097

Intervention Type DRUG

Once-weekly MET097 administered via subcutaneous injection

Placebo

Once-weekly placebo administered via subcutaneous injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once-weekly placebo administered via subcutaneous injection

Interventions

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MET097

Once-weekly MET097 administered via subcutaneous injection

Intervention Type DRUG

Placebo

Once-weekly placebo administered via subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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PF-08653944

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Metsera

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site 97301-001007

Riverside, California, United States

Site Status RECRUITING

Research Site 97301-001070

Torrance, California, United States

Site Status RECRUITING

Research Site 97301-001077

Englewood, Colorado, United States

Site Status RECRUITING

Research Site 97302-001001

Hollywood, Florida, United States

Site Status RECRUITING

Research Site 97301-001309

Cary, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Metsera Recruiting

Role: CONTACT

Phone: 888-746-7403

Email: [email protected]

Facility Contacts

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Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Other Identifiers

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MET097-25-301

Identifier Type: -

Identifier Source: org_study_id