A Study of MET233 in Combination With MET097 in Individuals With Obesity or Overweight With or Without Diabetes

NCT06924320 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: MET233/097-24-101C6511001
• Study Type: interventional
• Target: 381
• Locations: 1 country
• Sites: 1

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

Keywords

GLP-1; Metsera

Outcome Measures

Primary Outcomes (1)

• Occurrence of treatment-emergent adverse events (TEAEs)

  For Part A, B, C, D, E and G

  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)

Secondary Outcomes (17)

• Area under the concentration versus time curve extrapolated to infinity (AUCinf)

  Part A (Baseline, Day 85)

• Area under the concentration versus time curve during the dosing interval (AUCtau)

  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)

• Minimum observed concentration (Cmin)

  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)

• Maximum observed concentration (Cmax)

  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)

• Time to maximum observed concentration (Tmax)

  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)

Study Arms (6)

Part A Cohort

EXPERIMENTAL

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

Drug: MET233 and MET097; Other: Placebo

Part B Cohort

EXPERIMENTAL

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

Drug: MET233 and MET097; Other: Placebo

Part C Cohort

EXPERIMENTAL

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

Drug: MET233 and MET097; Other: Placebo

Part D Cohort

EXPERIMENTAL

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.

Drug: MET233 and MET097; Other: Placebo

Part E Cohort

EXPERIMENTAL

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.

Drug: MET233 and MET097; Other: Placebo

Part G Cohort

EXPERIMENTAL

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

Other: Placebo; Drug: MET097

Interventions

MET233 and MET097 DRUG

For subcutaneous administration

Part A Cohort; Part B Cohort; Part C Cohort; Part D Cohort; Part E Cohort

Placebo OTHER

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

Part A Cohort; Part B Cohort; Part C Cohort; Part D Cohort; Part E Cohort; Part G Cohort

MET097 DRUG

For subcutaneous administration

Part G Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Altasciences Clinical Los Angeles, Inc.

Cypress, California, 90630, United States

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 11, 2025
• Study Start: March 6, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)