Testing MET233 and MET097 for treating obesity and diabetes
A Phase 1 Randomized, Double-Blind, Placebo Controlled. Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MET233 Co-administered With MET097 in Adult Participants With Obesity or Overweight Including Participants With Type 2 Diabetes Mellitus
PHASE1; PHASE2 · Pfizer · NCT06924320
This study is testing if a new combination of two medications can help people who are overweight or have obesity, with or without type 2 diabetes, to manage their condition better.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Pfizer (industry) |
| Locations | 1 site (Cypress, California) |
| Trial ID | NCT06924320 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of the combination of MET233 and MET097 in treating individuals with obesity or overweight, with or without type 2 diabetes. It is a randomized, placebo-controlled, double-blind, double-dummy trial that assesses the safety, tolerability, pharmacokinetics, and pharmacodynamics of the treatments. Participants will receive either the active drugs or a placebo over a series of doses, followed by safety evaluations. The study includes different parts for participants with and without diabetes, ensuring a comprehensive approach to obesity management.
Who should consider this trial
Good fit: Ideal candidates are adults with a BMI between 27 and 38 kg/m2, including those with well-controlled type 2 diabetes.
Not a fit: Patients who are pregnant, lactating, or have uncontrolled hypertension or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for individuals struggling with obesity and related conditions.
How similar studies have performed: Other studies have shown promise with similar GLP-1 based approaches, indicating potential for success in this novel combination.
Eligibility criteria
Show full inclusion / exclusion criteria
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 history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome. * Lifetime history of acute or chronic pancreatitis or pancreatic cancer. * Participation in a weight loss program with or without pharmacotherapy during the 3 months prior to study administration or plans to do so.
Where this trial is running
Cypress, California
- Research Site MET233/097 24-101-001 — Cypress, California, United States (RECRUITING)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity and Obesity-related Medical Conditions, GLP-1, Metsera