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

A PHASE 1/2A 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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity and Obesity-related Medical Conditions
• Intervention / Treatment: Drug: MET233 and MET097; Other: Placebo; Drug: MET097

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 45 kg/m2 (inclusive), 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 12 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. For Part D, after the up to 4-week screening period, the study includes weekly and monthly (ie, every 4 weeks [QM]) and an approximate 11-week safety follow-up after last administration. For Part E, after the up to 4-week screening period, the study includes multiple dose QW-to-QM and an approximate 11-week safety followup after last administration. For Part G, after the up to 4-week screening period, the study includes multiple dose cohort of QW and QM and an approximate 11-week safety followup after last administration.

• Study Type: Interventional
• Enrollment (Estimated): 381
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • Recruiting
      • Altasciences Clinical Los Angeles, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: MET233 and MET097; For subcutaneous administration; Other: Placebo; Sterile 0.9% (w/v) saline for subcutaneous administration.
Experimental: Part B Cohort; Cohort Participants will receive multiple ascending dose (MAD) of co-administered SC MET233 with SC MET097 or matched SC placebo.	Drug: MET233 and MET097; For subcutaneous administration; Other: Placebo; Sterile 0.9% (w/v) saline for subcutaneous administration.
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.	Drug: MET233 and MET097; For subcutaneous administration; Other: Placebo; Sterile 0.9% (w/v) saline for subcutaneous administration.
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.	Drug: MET233 and MET097; For subcutaneous administration; Other: Placebo; Sterile 0.9% (w/v) saline for subcutaneous administration.
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.	Drug: MET233 and MET097; For subcutaneous administration; Other: Placebo; Sterile 0.9% (w/v) saline for subcutaneous administration.
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.	Other: Placebo; Sterile 0.9% (w/v) saline for subcutaneous administration.; Drug: MET097; For subcutaneous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the concentration versus time curve extrapolated to infinity (AUCinf)	For Part A	Part A (Baseline, Day 85)
Area under the concentration versus time curve during the dosing interval (AUCtau)	For Part B, C, D, E, and G	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)	For Part B, C, D, E, and G	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)	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)
Time to maximum observed concentration (Tmax)	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)
Part A: Percent change from baseline in body weight at Day 8	For Part A	Baseline, Day 8
Part A: Percent change from baseline in body weight at all other postbaseline weight measurements	For Part A	Part A (Baseline, Day 85)
Part B and Part C: Percent change from baseline in body weight at Day 85		Baseline, Day 85
Part B and Part C: Percent change from baseline in body weight at all other postbaseline weight measurements		Part B and Part C (Baseline, Day 155)
Percent change from baseline in body weight at Day 106	Part B (Cohorts B4-B6) and Part C	Baseline, Day 106
Percent change from baseline in body weight at all other postbaseline weight measurements	Part B (Cohorts B4-B6) and Part C	Part B and Part C (Baseline through Day 155)
Percent change from baseline in body weight at Day 113 and after QM dosing regimen complete	For Part D	Part D (Baseline, Day 113 and Day 169)
Percent change from baseline in body weight at all other postbaseline weight measurements	Part D	Part D (Baseline through Day 218)
Percent change from baseline in body weight after QW dosing regimen complete and after QM dosing regimen complete	For Part E	Part E (Baseline, Day 141 and Day 197)
Percent change from baseline in body weight at all other postbaseline weight measurements	For Part E	Part E (Baseline through Day 246)
Percent change from baseline in body weight after QW dosing regimen complete and after QM dosing regimen complete	For Part G	Part G (Baseline, Day 113 and Day 225)
Percent change from baseline in body weight at all other postbaseline weight measurements	For Part G	Part G (Baseline through Day 274)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026

Study Registration Dates

• First Submitted: April 3, 2025
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: GLP-1; Metsera
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: MET233/097-24-101 (Other Identifier: Alias Study Number); C6511001 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No