Clinical trial NCT06857617: This Study Will Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MET097 in Adult Participants With Overweight or Obesity
Official title: A Phase 1/2 Randomized Placebo-Controlled Double-Blind Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Doses of MET097 in Adult Participants With Obesity and Overweight But Otherwise Healthy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Obesity and Overweight
Lead sponsor: Metsera
Sponsor class: INDUSTRY
First posted: 2025-03-04
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part A (72 participants), Part B (70 participants), Part C (120 participants)
Primary purpose: TREATMENT

Brief summary: The goal of this Phase 1/2 clinical trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of once-weekly subcutaneous injections of MET097 in otherwise healthy adults with overweight or obesity.

The trial will be conducted in three parts. Part A consists of single ascending dose (SAD) cohorts of MET097 or placebo. Part B consists of multiple ascending dose (MAD) cohorts, with participants treated with five once-weekly doses of MET097 or placebo. In Part C, participants will receive once-weekly doses of MET097 or placebo for 12 weeks, followed by a single dose at 2X or 4X to explore the potential for once-monthly dosing.


Eligibility criteria: Inclusion Criteria:

* Overweight/Obese but otherwise healthy adult male or female with a BMI within 27.0 kg/m2 to 38.0 kg/m2, inclusively
* At least 18 years of age but not older than 70 years of age
* Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an Investigator
* Estimated glomerular filtration rate (eGFR) ≥90 mL/min at the Screening visit

Exclusion Criteria:

* Female who is lactating or who is pregnant according to the pregnancy test at the Screening visit or prior to the first study drug administration
* Seated blood pressure higher than 160/95 mmHg at the Screening visit
* Elevated resting pulse greater than 100 beats per minute at Screening visit
* Presence of clinically significant ECG abnormalities
* Diagnosis of diabetes (type 1 or type 2)
* Participation in a weight loss program with or without pharmacotherapy during the 3 months prior to study administration
* Obesity induced by endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., Melanocortin 4 Receptor deficiency or Prader-Willi Syndrome).
* Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type

Primary outcomes:
measure: (Part C) Percent change from baseline in body weight at Week 12 (Day 85).
timeFrame: Day 1 (Week 0) to Day 85 (Week 12)
Secondary outcomes:
measure: (Part C) To characterize the maximum observed concentration (Cmax).
timeFrame: Day 1 (Week 0) to Day 160 (Week 31)
measure: (Part C) To characterize the time of maximum observed concentration (Tmax).
timeFrame: Day 1 (Week 0) to Day 160 (Week 31)
measure: (Part C) To characterize the area under the concentration versus time curve (AUC).
timeFrame: Day 1 (Week 0) to Day 160 (Week 31)
measure: (Part C) To characterize the elimination half-life (t1/2).
timeFrame: Day 1 (Week 0) to Day 160 (Week 31)
measure: (Part C) Occurrence of treatment-emergent adverse events (TEAEs) through Week 12.
timeFrame: Day 1 (Week 0) to Day 85 (Week 12)
measure: (Part C) Occurrence of TEAEs following the 13th dose.
timeFrame: Day 85 (Week 12) to Day 160 (Week 31)
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Research Site MET097 23-101-002
state: California
city: Cypress
country: United States
facility: Research Site MET097 23-101-003
state: California
city: Overland Park
country: United States
facility: Research Site MET097 23-101-001
state: Kansas
Study officials:
References: