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

Purpose

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.

Condition

Obesity and Overweight

Eligibility

Eligible Ages: Between 18 Years and 99 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental MET097 Dose 1	Participants will receive MET097 administered subcutaneously	Drug: MET097 Once-weekly MET097 administered via subcutaneous injection Other names: PF-08653944
Experimental MET097 Dose 2	Participants will receive MET097 administered subcutaneously	Drug: MET097 Once-weekly MET097 administered via subcutaneous injection Other names: PF-08653944
Experimental MET097 Dose 3	Participants will receive MET097 administered subcutaneously	Drug: MET097 Once-weekly MET097 administered via subcutaneous injection Other names: PF-08653944
Placebo Comparator Placebo	Once-weekly placebo administered via subcutaneous injection	Drug: Placebo Once-weekly placebo administered via subcutaneous injection

Recruiting Locations

Research Site 97301-001007
Riverside 5387877, California 5332921 92506

Research Site 97301-001070
Torrance 5403022, California 5332921 90504

Research Site 97301-001077
Englewood 5421250, Colorado 5417618 80113

Research Site 97302-001001
Hollywood 4158928, Florida 4155751 33024

Research Site 97301-001309
Cary 4459467, North Carolina 4482348 27511

More Details

NCT ID: NCT07311850
Status: Recruiting
Sponsor: Metsera, a wholly owned subsidiary of Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.