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Clinical Trial NCT06924320 for Obesity and Obesity-related Medical Conditions is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Metsera, a wholly owned subsidiary of PfizerA Study of MET233 in Combination With MET097 in Individuals With Obesity or Overweight With or Without Diabetes Phase 1, Phase 2 132
Clinical Trial NCT06924320 is designed to study Treatment for Obesity and Obesity-related Medical Conditions. It is a Phase 1 Phase 2 interventional study that is recruiting, having started on March 3, 2025, with plans to enroll 132 participants. Led by Metsera, a wholly owned subsidiary of Pfizer, it is expected to complete by March 15, 2027. The latest data from ClinicalTrials.gov was last updated on February 3, 2026.
Brief 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.
Detailed Description
This is a randomized, placebo-controlled, double-blind, double-dummy study to investigate the safety, tolerability, PK, and PD of subcutaneous (SC) doses of MET233 co-administered with MET097 in adult participants with a BMI of 27 to 38 kg/m2, including some participants with T2DM. For Part A, after the up to 4-week screening period, the study includes 1 dose and a 12-week safety follow-up after administration. For P...Show More
Official Title
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
Conditions
Obesity and Obesity-related Medical ConditionsOther Study IDs
- MET233/097-24-101
NCT ID Number
Start Date (Actual)
2025-03-03
Last Update Posted
2026-02-03
Completion Date (Estimated)
2027-03-15
Enrollment (Estimated)
132
Study Type
Interventional
PHASE
Phase 1
Phase 2
Phase 2
Status
Recruiting
Keywords
GLP-1
Metsera
Metsera
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalSAD: MET233 co-administered with MET097 Participants in the single ascending dose cohorts will receive subcutaneous MET233 co-administered with MET097 at a single point in time. | MET233 and MET097 For subcutaneous administration |
Placebo ComparatorSAD: Placebo Participants in the single ascending dose cohorts will receive subcutaneous Placebo at a single point in time. | Placebo Sterile 0.9% (w/v) saline for subcutaneous administration. |
ExperimentalMAD: MET233 co-administered with MET097 Participants in the multiple ascending dose cohorts will receive subcutaneous MET233 co-administered with MET097 weekly. | MET233 and MET097 For subcutaneous administration |
Placebo ComparatorMAD: Placebo Participants in the multiple ascending dose cohorts will receive subcutaneous Placebo weekly. | Placebo Sterile 0.9% (w/v) saline for subcutaneous administration. |
ExperimentalMAD: MET233 co-administered with Placebo Participants will receive subcutaneous MET233 co-administered with Placebo weekly. | MET233 For subcutaneous administration |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Part A: Occurrence of treatment-emergent adverse events (TEAEs) | Baseline (Week 0) to Day 85 (Week 12) | |
Part B: Occurrence of treatment-emergent adverse events (TEAEs) | Baseline (Week 0) to Day 155 (Week 22) | |
Part C: Occurrence of treatment-emergent adverse events (TEAEs) | Baseline (Week 0) to Day 155 (Week 22) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Part A: Maximum observed concentration (Cmax) | Baseline (Week 0 ) through Day 85 (Week 12) | |
Part B: Maximum observed concentration (Cmax) | Baseline (Week 0 ) through Day 155 (Week 22) | |
Part C: Maximum observed concentration (Cmax) | Baseline (Week 0 ) through Day 155 (Week 22) | |
Part A: Area under the concentration versus time curve (AUC) | Baseline (Week 0 ) through Day 85 (Week 12) | |
Part B: Area under the concentration versus time curve (AUC) | Baseline (Week 0 ) through Day 155 (Week 22) | |
Part C: Area under the concentration versus time curve (AUC) | Baseline (Week 0 ) through Day 155 (Week 22) | |
Part A: Time to maximum observed concentration (Tmax) | Baseline (Week 0 ) through Day 85 (Week 12) | |
Part B: Time to maximum observed concentration (Tmax) | Baseline (Week 0 ) through Day 155 (Week 22) | |
Part C: Time to maximum observed concentration (Tmax) | Baseline (Week 0 ) through Day 155 (Week 22) | |
Part A: Minimum observed concentration (Cmin) | Baseline (Week 0 ) through Day 85 (Week 12) | |
Part B: Minimum observed concentration (Cmin) | Baseline (Week 0 ) through Day 155 (Week 22) | |
Part C: Minimum observed concentration (Cmin) | Baseline (Week 0 ) through Day 155 (Week 22) | |
Part A: Percent change from baseline in body weight | Weekly post-baseline up to Day 85 (Week 12) | |
Part B: Percent change from baseline in body weight | Weekly post-baseline up to Day 155 (Week 22) | |
Part C: Percent change from baseline in body weight | Weekly post-baseline up to Day 155 (Week 22) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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.
Metsera, a wholly owned subsidiary of Pfizer7 active studies to exploreStudy Central Contact
Contact: Pfizer CT.gov Call Center, 1-800-718-1021, [email protected]
1 Study Locations in 1 Countries
California
Research Site MET233/097 24-101-001, Cypress, California, 90630, United States
Recruiting