Efficacy and Safety of MET097 Once-Weekly in People With Overweight or Obesity
ConditionObesity and Overweight
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 groupsLocations
170Bulgaria
MHAT Botevgrad2140, Botevgrad Bulgaria
Medical Center 4Life EOOD8018, Burgas Bulgaria
Multiprofile Hospital for Active Treatment Dobrich AD (MHAT Dobrich AD)9300, Dobrich Bulgaria
Medical Center New Polyclinic Gabrovo Ltd.5300, Gabrovo Bulgaria
Sponsors and collaborators
Pfizer
Lead sponsor
Source ClinicalTrials.gov