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

Metsera, a wholly owned subsidiary of Pfizer

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Obesity and Obesity-related Medical Conditions

Treatments: Drug: MET233; Drug: MET233 and MET097; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06924320

MET233/097-24-101

Details and patient eligibility

About

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.

Full 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 38 kg/m2, 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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 5 patient groups, including a placebo group

SAD: MET233 co-administered with MET097

Experimental group

Description:

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

Treatment:

Drug: MET233 and MET097

SAD: Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

MAD: MET233 co-administered with MET097

Experimental group

Description:

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

Treatment:

Drug: MET233 and MET097

MAD: Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

MAD: MET233 co-administered with Placebo

Experimental group

Description:

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

Treatment:

Drug: MET233