Clinical trial NCT06924320: A Study of MET233 in Combination With MET097 in Individuals With Obesity or Overweight With or Without Diabetes
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Obesity and Obesity-related Medical Conditions
Keywords: GLP-1
Metsera
Lead sponsor: Metsera
Sponsor class: INDUSTRY
First posted: 2025-04-11
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Part B and Part C, after the up to 4-week screening period, the study includes 5 once-weekly doses and an approximately 11-week safety follow-up after the last administration. Parts A and B will include only participants with overweight or obesity without type 2 diabetes. Part C will include participants with overweight or obesity who also have type 2 diabetes.

Eligibility 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.

Primary outcomes:
measure: Part A: Occurrence of treatment-emergent adverse events (TEAEs)
timeFrame: Baseline (Week 0) to Day 85 (Week 12)
measure: Part B: Occurrence of treatment-emergent adverse events (TEAEs)
timeFrame: Baseline (Week 0) to Day 104 (Week 15)
measure: Part C: Occurrence of treatment-emergent adverse events (TEAEs)
timeFrame: Baseline (Week 0) to Day 104 (Week 15)
Secondary outcomes:
measure: Part A: Maximum observed concentration (Cmax)
timeFrame: Baseline (Week 0 ) through Day 85 (Week 12)
measure: Part B: Maximum observed concentration (Cmax)
timeFrame: Baseline (Week 0 ) through Day 104 (Week 15)
measure: Part C: Maximum observed concentration (Cmax)
timeFrame: Baseline (Week 0 ) through Day 104 (Week 15)
measure: Part A: Area under the concentration versus time curve (AUC)
timeFrame: Baseline (Week 0 ) through Day 85 (Week 12)
measure: Part B: Area under the concentration versus time curve (AUC)
timeFrame: Baseline (Week 0 ) through Day 104 (Week 15)
measure: Part C: Area under the concentration versus time curve (AUC)
timeFrame: Baseline (Week 0 ) through Day 104 (Week 15)
measure: Part A: Time to maximum observed concentration (Tmax)
timeFrame: Baseline (Week 0 ) through Day 85 (Week 12)
measure: Part B: Time to maximum observed concentration (Tmax)
timeFrame: Baseline (Week 0 ) through Day 104 (Week 15)
measure: Part C: Time to maximum observed concentration (Tmax)
timeFrame: Baseline (Week 0 ) through Day 104 (Week 15)
measure: Part A: Minimum observed concentration (Cmin)
timeFrame: Baseline (Week 0 ) through Day 85 (Week 12)
measure: Part B: Minimum observed concentration (Cmin)
timeFrame: Baseline (Week 0 ) through Day 104 (Week 15)
measure: Part C: Minimum observed concentration (Cmin)
timeFrame: Baseline (Week 0 ) through Day 104 (Week 15)
measure: Part A: Percent change from baseline in body weight
timeFrame: Weekly post-baseline up to Day 85 (Week 12)
measure: Part B: Percent change from baseline in body weight
timeFrame: Weekly post-baseline up to Day 104 (Week 15)
measure: Part C: Percent change from baseline in body weight
timeFrame: Weekly post-baseline up to Day 104 (Week 15)
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Research Site MET233/097 24-101-001
state: California
Study officials:
References: