Obesity and Overweight
Conditions
Brief summary
The goal of this clinical trial is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-weekly subcutaneous injections of MET233 in otherwise healthy adults with overweight or obesity. This study will be conducted in four parts: * Part A will evaluate single ascending doses of MET233 or placebo. * Part B will evaluate multiple ascending doses, with participants receiving five once-weekly doses of MET233 or placebo. * Part C will evaluate once-weekly dosing of MET233 or placebo for 12 weeks, followed by a single higher, potential monthly dose. * Part D will evaluate a longer dosing schedule, in which participants will receive twelve once-weekly doses, followed by three monthly doses of MET233 or placebo. Participants in this part will be followed for 14 weeks after the final dose.
Detailed description
This is a randomized, placebo-controlled, double-blind study designed to investigate the safety, tolerability, PK and pharmacodynamic (PD) of single and multiple ascending subcutaneous (SC) doses of MET233 in otherwise healthy adult participants with obesity or overweight (body mass index \[BMI\] 27.0 kg/m2 to 38.0 kg/m2, inclusive for Parts A-C and BMI in Part D 30- 45.0 kg/m2 (inclusive). * In Part A, participants will receive a single dose of MET233 at up to five dose levels. * In Part B, participants will receive five weekly doses of MET233 at up to four dose levels. * In Part C, participants will receive 12 weekly doses of MET233. These doses may include titration. For all cohorts in Part C, a 13th dose administered on Day 85 may be a monthly-equivalent dose to evaluate the potential for switching to a monthly dosing regimen. * In Part D, participants will receive 12 once-weekly doses, followed by three monthly doses of MET233 or placebo.
Interventions
BIOLOGICALMET233
For subcutaneous administration
BIOLOGICALPlacebo
Sterile 0.9% (w/v) saline for subcutaneous administration
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult (≥18 to ≤70 years) male and female participants with obesity or overweight (BMI 27.0 kg/m2 to 38.0 kg/m2, inclusive) but otherwise healthy.
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of Treatment Emergent Adverse Events | Part A (Baseline to Day 85), Part B (Baseline to Day 113), Part C (Baseline to Day 162), Part D (Baseline to Day 239) |
Secondary
| Measure | Time frame |
|---|---|
| Area under the concentration versus time curve extrapolated to infinity (AUCinf) | Part A (Baseline to Day 85) |
| Area under the concentration versus time curve during the dosing interval (AUCtau) | Part B (Baseline to Day 113), Part C (Baseline to Day 162), Part D (Baseline to Day 239) |
| Maximum observed concentration (Cmax) | Part A (Baseline to Day 85), Part B (Baseline to Day 113), Part C (Baseline to Day 162), Part D (Baseline to Day 239) |
| Time to maximum observed concentration (Tmax) | Part A (Baseline to Day 85), Part B (Baseline to Day 113), Part C (Baseline to Day 162), Part D (Baseline to Day 239) |
| Elimination half-life (t1/2) | Part A (Baseline to Day 85), Part B (Baseline to Day 113), Part C (Baseline to Day 162), Part D (Baseline to Day 239) |
| Percent change from baseline in body weight at the protocol-specified weekly post-baseline measurements | Part A (Baseline to Day 85), Part B (Baseline to Day 113), Part C (Baseline to Day 162), Part D (Baseline to Day 239) |
Countries
United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed