Efficacy and Safety of MET097 Once-Weekly in People With Overweight or Obesity (VESPER-4)

Metsera, a wholly owned subsidiary of Pfizer

Status and phase: Enrolling; Phase 3

Conditions: Obesity and Overweight

Treatments: Drug: Placebo; Drug: MET097

Study type: Interventional

Funder types: Industry

Identifiers

NCT07311850

MET097-25-301

Details and patient eligibility

About

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.

Enrollment: 3,500 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,500 participants in 4 patient groups, including a placebo group

MET097 Dose 1

Experimental group

Description:

Participants will receive MET097 administered subcutaneously

Treatment:

Drug: MET097

MET097 Dose 2

Experimental group

Description:

Participants will receive MET097 administered subcutaneously

Treatment:

Drug: MET097

MET097 Dose 3

Experimental group

Description:

Participants will receive MET097 administered subcutaneously

Treatment:

Drug: MET097

Placebo

Placebo Comparator group

Description:

Once-weekly placebo administered via subcutaneous injection

Treatment:

Drug: Placebo