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

NCT06924320 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: MET233/097-24-101
• Study Type: interventional
• Target: 132
• 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 (3)

• Part A: Occurrence of treatment-emergent adverse events (TEAEs)

  Baseline (Week 0) to Day 85 (Week 12)

• Part B: Occurrence of treatment-emergent adverse events (TEAEs)

  Baseline (Week 0) to Day 155 (Week 22)

• Part C: Occurrence of treatment-emergent adverse events (TEAEs)

  Baseline (Week 0) to Day 155 (Week 22)

Secondary Outcomes (15)

• Part A: Maximum observed concentration (Cmax)

  Baseline (Week 0 ) through Day 85 (Week 12)

• Part B: Maximum observed concentration (Cmax)

  Baseline (Week 0 ) through Day 155 (Week 22)

• Part C: Maximum observed concentration (Cmax)

  Baseline (Week 0 ) through Day 155 (Week 22)

• Part A: Area under the concentration versus time curve (AUC)

  Baseline (Week 0 ) through Day 85 (Week 12)

• Part B: Area under the concentration versus time curve (AUC)

  Baseline (Week 0 ) through Day 155 (Week 22)

Study Arms (5)

SAD: MET233 co-administered with MET097

EXPERIMENTAL

Participants in the single ascending dose cohorts will receive subcutaneous MET233 co-administered with MET097 at a single point in time.

Drug: MET233 and MET097

SAD: Placebo

PLACEBO COMPARATOR

Participants in the single ascending dose cohorts will receive subcutaneous Placebo at a single point in time.

Drug: Placebo

MAD: MET233 co-administered with MET097

EXPERIMENTAL

Participants in the multiple ascending dose cohorts will receive subcutaneous MET233 co-administered with MET097 weekly.

Drug: MET233 and MET097

MAD: Placebo

PLACEBO COMPARATOR

Participants in the multiple ascending dose cohorts will receive subcutaneous Placebo weekly.

Drug: Placebo

MAD: MET233 co-administered with Placebo

EXPERIMENTAL

Participants will receive subcutaneous MET233 co-administered with Placebo weekly.

Drug: MET233

Interventions

MET233 and MET097 DRUG

For subcutaneous administration

MAD: MET233 co-administered with MET097; SAD: MET233 co-administered with MET097

Placebo DRUG

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

MAD: Placebo; SAD: Placebo

MET233 DRUG

For subcutaneous administration

MAD: MET233 co-administered with Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI ≥27 kg/m2 and ≤38.0 kg/m2 (inclusive) at screening
• For participants in Part A and B, no history of clinically significant diseases or clinically significant findings from the physical examination. For participants in Part C, no clinically significant diseases except T2DM, well controlled hypertension, and/or dyslipidemia.
• For participants in Part C, diagnosed with T2DM for at least 3 months before screening.
• For participants in Part C, T2DM includes glycated hemoglobin (HbA1c) value ≤10.5% at Screening and treated with stable therapy for at least 30 days prior to Screening/Visit 1.

You may not qualify if:

• Female who is lactating or who is pregnant according to the pregnancy test at Screening or on Day 1.
• 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 and Part B: 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 and Part B: Participant reported weight-related comorbidity, including sleep apnea and cardiovascular disease.
• History of bariatric or weight loss surgeries.
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome.
• Lifetime 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.

Sponsors & Collaborators

• Metsera, a wholly owned subsidiary of Pfizer: lead

Study Sites (1)

Research Site MET233/097 24-101-001

Cypress, California, 90630, United States

RECRUITING

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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 11, 2025
• Study Start: March 3, 2025
• Primary Completion (Estimated): January 25, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

US (1)