Recruiting
Phase 1
Phase 2

MET233 & MET097

Sponsor:

Pfizer

Code:

NCT06924320

Conditions

Obesity and Obesity-related Medical Conditions

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

MET233 and MET097

Placebo

MET097

Study Details

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.

Conditions

Obesity and Obesity-related Medical Conditions

Study ID

NCT06924320

Start date

Mar 6, 2025

Status verified date

May, 2026

Completion date

Sep 15, 2026

Anticipated

Primary completion date

Sep 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adult males or females aged 18 to 75 years (inclusive) at the time of screening.
  • BMI ≥27.0 kg/m2 and ≤38.0 kg/m2 (inclusive) at Screening for Parts A, B, and C, and ≥30.0 kg/m2 and ≤45.0 kg/m2 (inclusive) at Screening for Parts D and E. Have a BMI ≥27.0 kg/m2 and ≤45.0 kg/m2 (inclusive) at Screening for Parts G.
  • Participants must be in generally stable health, as determined by the investigator based on medical history, physical examination (including vital signs), laboratory evaluations, and electrocardiogram (ECG).

  • Participants must have no clinically significant diseases or clinically significant findings on the physical examination (including vital signs), laboratory evaluations, and electrocardiogram (ECG).
  • Participants in Parts C must not have clinically significant diseases except type 2 diabetes mellitus (T2DM), sleep apnea, well-controlled hypertension, and/or dyslipidemia.
  • Participants in Parts E and G must not have any clinically significant diseases except hypertension, dyslipidemia, and/or a clinical diagnosis of sleep apnea.
  • Willing and able to comply with all scheduled study visits, procedures, and required assessments.
  • Women of childbearing potential must be willing to comply with protocol-specified contraceptive requirements and must not plan to become pregnant during the study.

Exclusion Criteria:

  • Female who is lactating or who is pregnant according to the pregnancy test at Screening or on Day 1. Unwillingness or inability to comply with protocol-specified contraceptive requirements.
  • Clinically significant abnormalities in laboratory results in the opinion of the investigator, increase risk or interfere with study participation.
  • 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, Part B, Part D, Part E and Part G: 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, Part B and Part D: Participant reported weight-related comorbidity, including sleep apnea and cardiovascular disease.
  • Use of prohibited prescription or non-prescription medications, supplements, or investigational products within protocol-defined washout periods.
  • History or presence of clinically significant gastrointestinal, endocrine, respiratory, renal, hepatic, hematologic, neurologic, cardiovascular, psychiatric, immunologic, or other systemic diseases, except where explicitly permitted by the protocol.
  • Personal or family history of medullary thyroid carcinoma, multiple endocrine neoplasia syndrome, pancreatitis, or pancreatic cancer.
  • 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.
  • History of bariatric or weight-loss surgery.
  • Clinically significant psychiatric illness that may interfere with study participation or safety.
  • Screening assessments indicative of moderate to severe depression.
  • History of drug or alcohol abuse or dependence within the past 2 years.

Study Design

Enrollment

381 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A Cohort

Cohort participants will receive single co-administered ascending dose (SAD) of subcutaneous (SC) MET233 and SC MET097 or matched SC placebo.

experimental: Part B Cohort

Cohort Participants will receive multiple ascending dose (MAD) of co-administered SC MET233 with SC MET097 or matched SC placebo.

experimental: Part C Cohort

Cohort Participants will receive multiple doses of SC MET233 co-administered with SC MET097 or matched SC placebo in participants with T2DM.

experimental: Part D Cohort

Cohort Participants will receive multiple doses of weekly and monthly (ie, every 4 weeks \[QM\]) co-administered SC MET233 with SC MET097, or matched SC placebo in participants with obesity.

experimental: Part E Cohort

Cohort Participants will receive multiple dose QW-to-QM of SC MET233 co-administered with SC MET097 or matched SC placebo in participants with obesity.

experimental: Part G Cohort

Cohort Participants will receive multiple dose cohort of QW and QM SC MET097 monotherapy or matched SC placebo in participants with obesity or overweight.

Interventions

MET233 and MET097

For subcutaneous administration

Placebo

Sterile 0.9% (w/v) saline for subcutaneous administration.

MET097

For subcutaneous administration

Primary outcome measure

  • Occurrence of treatment-emergent adverse events (TEAEs) [ Time Frame: Part A (Baseline, Day 85), Part B (Baseline, Day 155), Part C (Baseline, Day 155), Part D (Baseline, Day 218), Part E (Baseline, Day 246), Part G (Baseline, Day 274) ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Altasciences Clinical Los Angeles, Inc.

Recruiting

Cypress, California, United States, 90630

More Information

Sponsor

Pfizer

Last update posted

Jun 1, 2026

Last verified

May, 2026

Keywords

  • GLP-1
  • Metsera

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pfizer on 2026-06-01.