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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Treatments tested in this trial

  • MET097
  • Placebo

Treatment groups

3,501 Participants
are divided into 4 treatment groups

Sponsors and collaborators