A Study of MET233 in Combination With MET097 in Individuals With Obesity or Overweight With or Wi… (NCT06924320) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of MET233 in Combination With MET097 in Individuals With Obesity or Overweight With or Without Diabetes
United States132 participantsStarted 2025-03-03
Plain-language summary
This study is designed to test how well the combination of MET233 with MET097 works to treat individuals with obesity or overweight with or without diabetes.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* BMI ≥27 kg/m2 and ≤38.0 kg/m2 (inclusive) at screening
* For participants in Part A and B, no history of clinically significant diseases or clinically significant findings from the physical examination. For participants in Part C, no clinically significant diseases except T2DM, well controlled hypertension, and/or dyslipidemia.
* For participants in Part C, diagnosed with T2DM for at least 3 months before screening.
* For participants in Part C, T2DM includes glycated hemoglobin (HbA1c) value ≤10.5% at Screening and treated with stable therapy for at least 30 days prior to Screening/Visit 1.
Exclusion Criteria:
* Female who is lactating or who is pregnant according to the pregnancy test at Screening or on Day 1.
* Seated blood pressure higher than 160/100 mmHg at the Screening visit or prior to the first study drug administration.
* Elevated resting pulse greater than 100 beats per minute at Screening visit or prior to the first study drug administration.
* Estimated glomerular filtration rate (eGFR) \<80 mL/min at the Screening visit.
* Diagnosis of Type 1 diabetes.
* For Part A and Part B: Diagnosis of T2DM or glycated hemoglobin (HbA1c) \> 6.4% or fasting plasma glucose \>126 mg/dL at the Screening visit or history of taking any medications to lower glucose.
* For Part A and Part B: Participant reported weight-related comorbidity, including sleep apnea and cardiovascular disease.
* History of bariatric or weight loss surgeries.
* Personal or family…
What they're measuring
1
Part A: Occurrence of treatment-emergent adverse events (TEAEs)
Timeframe: Baseline (Week 0) to Day 85 (Week 12)
2
Part B: Occurrence of treatment-emergent adverse events (TEAEs)
Timeframe: Baseline (Week 0) to Day 155 (Week 22)
3
Part C: Occurrence of treatment-emergent adverse events (TEAEs)
Timeframe: Baseline (Week 0) to Day 155 (Week 22)
Trial details
NCT IDNCT06924320
SponsorMetsera, a wholly owned subsidiary of Pfizer