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

ArmDescriptionAssigned 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

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