Actively Recruiting
A Phase 1/2a Randomized, Double-Blind, Placebo-Controlled Study to Investigate Safety and Effects of MET233 with MET097 in Adults with Obesity or Overweight, Including Those with Type 2 Diabetes
Led by Pfizer · Updated on 2026-06-01
381
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying how well the combination of MET233 and MET097 works to treat adults who are overweight or have obesity, including some with type 2 diabetes. This is a randomized, placebo-controlled, double-blind study focusing on safety, tolerability, and how the drugs behave in the body. The study includes adults with a body mass index (BMI) between 27 and 45 kg/m2, with certain parts including participants with type 2 diabetes. The study has several parts (A, B, C, D, E, and G) with different dosing schedules. Participants receive subcutaneous (under the skin) doses of MET233 combined with MET097 or a matching placebo. Some parts involve single ascending doses, others multiple weekly or monthly doses. After each treatment phase, there is a safety follow-up period lasting from about 12 weeks up to 11 weeks depending on the part. Participants will be monitored through scheduled visits including physical exams, lab tests, ECGs, and assessments of body weight changes. Researchers will track treatment-emergent adverse events and measure drug concentrations in the blood after dosing. The total study participation varies by part but includes screening, treatment doses, and extended safety follow-up periods. Participants need to comply with all study procedures and assessments throughout the study.
CONDITIONS
Brief Title
A Study of MET233 in Combination With MET097 in Individuals With Obesity or Overweight With or Without Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult males or females aged 18 to 75 years at screening.
- Body mass index (BMI) between 27.0 and 38.0 kg/m2 for Parts A, B, and C.
- BMI between 30.0 and 45.0 kg/m2 for Parts D and E.
- BMI between 27.0 and 45.0 kg/m2 for Part G.
- Generally stable health with no significant diseases or abnormal findings.
- Participants in Part C may have type 2 diabetes, sleep apnea, well-controlled hypertension, or dyslipidemia.
- Participants in Parts E and G may have hypertension, dyslipidemia, or diagnosed sleep apnea.
- Willing and able to comply with all study visits and procedures.
- Women of childbearing potential must agree to use contraception and not plan pregnancy during the study.
You will not qualify if you...
- Pregnant or breastfeeding women or those unwilling to use contraception.
- Clinically significant lab abnormalities that increase risk or interfere with participation.
- Seated blood pressure over 160/100 mmHg at screening or before dosing.
- Resting pulse rate over 100 beats per minute at screening or before dosing.
- Estimated glomerular filtration rate (eGFR) below 80 mL/min at screening.
- Diagnosis of type 1 diabetes.
- For Parts A, B, D, E, and G: diagnosis of type 2 diabetes or elevated HbA1c over 6.4%, fasting plasma glucose over 126 mg/dL, or history of glucose-lowering medication.
- Weight-related comorbidities such as sleep apnea or cardiovascular disease for Parts A, B, and D.
- Use of prohibited medications, supplements, or investigational products during required washout periods.
- History or presence of significant gastrointestinal, endocrine, respiratory, renal, hepatic, hematologic, neurologic, cardiovascular, psychiatric, immunologic, or other systemic diseases except as allowed.
- Personal or family history of medullary thyroid carcinoma, multiple endocrine neoplasia syndrome, pancreatitis, or pancreatic cancer.
- History of acute or chronic pancreatitis or pancreatic cancer.
- Participation in weight loss programs or bariatric surgery within 3 months before the study.
- Significant psychiatric illness or moderate to severe depression.
- Drug or alcohol abuse or dependence within the past 2 years.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single dose for Part A; 12 once-weekly doses for Parts B and C; weekly and monthly doses for Parts D, E, and G
Participants receive subcutaneous doses of MET233 co-administered with MET097 or matched placebo according to their assigned cohort.
1 dose visit for Part A; weekly visits for 12 weeks for Parts B and C; weekly and monthly visits for Parts D, E, and G
Duration - Approximately 12 weeks for Part A; approximately 11 weeks for Parts B, C, D, E, and G
Participants are monitored for safety after the last dose administration.
Approximately 1 to 3 visits depending on cohort
Trial Site Locations
Total: 1 location
1
Altasciences Clinical Los Angeles, Inc.
Cypress, California, United States, 90630
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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