RECRUITING

A Study to Evaluate the Effect of Maridebart Cafraglutide on Insulin Sensitivity and β-cell Function in Participants With Type 2 Diabetes Mellitus

Conditions

Type 2 Diabetes Mellitus T2DM Maridebart Cafraglutide AMG 133 Insulin sensitivity β-cell Function

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of this study is to determine the effect of maridebart cafraglutide relative to placebo on insulin sensitivity in participants with Type 2 Diabetes Mellitus (T2DM) treated with stable dose of metformin.

Official Title

A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Maridebart Cafraglutide on Insulin Sensitivity and β-cell Function in Participants With Type 2 Diabetes Mellitus

Quick Facts

Study Start:2025-09-09

Study Completion:2026-12-13

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07160257

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Informed consent before initiation of any study-specific activities/procedures. * Male or female participants aged ≥ 18 and ≤ 70 years at the time of signing informed consent. * Body mass index 27 ≥ and ≤ 45 kg/m\^2 at screening. * Diagnosis of T2DM at least 6 months before screening based on the WHO classification. * Treatment of T2DM for at least 3 months prior to screening with diet and exercise and a stable dose of metformin (either immediate release or extended release), with or without a stable dose of 1 additional OAM other than metformin.	* Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma, or any other type of diabetes mellitus (except T2DM or history of gestational diabetes). * History of proliferative diabetic retinopathy or diabetic macular edema or nonproliferative diabetic retinopathy that requires acute treatment. * One or more episodes of severe hypoglycemia (Level 3 hypoglycemia as defined by the American Diabetes Association classification criteria7 ) within 6 months before screening, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery. * Has modified diet or adopted any nutritional lifestyle modifications within 3 months prior to screening, as assessed by the investigator (or designee) based on participant self-report * History of malignancy within the last 5 years before screening (except nonmelanoma skin cancers, cervical carcinoma in situ, or breast ductal carcinoma in situ). * Family (first-degree relative\[s\]) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2). * History or evidence of endocrine disorder (such as Cushing's syndrome) that can cause obesity. * History or evidence of autoimmune disease that can directly or indirectly affect insulin production, insulin action, or glucose metabolism. * History of any of the following within 90 days before screening: myocardial infarction, unstable angina, coronary artery bypass graft surgery or other major cardiovascular surgery, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, cerebrovascular accident, or decompensated congestive heart failure, or currently have New York Heart Association Class III or IV heart failure. * History of chronic pancreatitis. * History of acute pancreatitis within 6 months before screening. * Positive human immunodeficiency virus test at screening. * Evidence of hepatitis B or C infection based on 1 or more of the following results and/or criteria at screening * Estimated glomerular filtration rate \< 60 mL/min/1.73 m2 calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration creatinine-cystatin C equation at screening or check-in (Day -4). * Hemoglobin value \< 12 g/dL (males) or \< 11 g/dL (females) at screening or check-in (Day -4). * Use within 90 days before randomization of medications, supplements, or alternative remedies for weight loss (eg, GLP-1RA, GIP agonists, phentermine/topiramate, naltrexone/bupropion, orlistat, and sympathomimetic drugs). * Use within 90 days before randomization of chronic (\> 14 days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intraarticular, or inhaled preparations). * Use within 90 days before randomization of medications that may cause significant weight gain including, but not limited to, tricyclic antidepressants, atypical antipsychotic, and mood stabilizers. * Current or prior use of herbal supplements that affect insulin or glucose within 30 days before randomization. * Currently receiving treatment in another investigational device or drug study, or less than 30 days (or 5 half-lives, whichever is longer) since ending treatment on another investigational device or drug study(ies). * Participants of childbearing potential unwilling to adhere to contraception requirements during treatment and for an additional 16 weeks after the last dose of IMP. * Participants who are breastfeeding or who plan to breastfeed while on study through 16 weeks after the last dose of IMP. * Participants planning to become pregnant while on study through 16 weeks after the last dose of IMP. * Major surgical procedure planned during the study. * Participant has known sensitivity to any of the products or components to be administered during dosing. * Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge. * History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the investigator or medical monitor, if consulted as necessary, would pose a risk to participant's safety or interfere with the study evaluation, procedures, or completion.

Inclusion Criteria

Exclusion Criteria

* Informed consent before initiation of any study-specific activities/procedures.
* Male or female participants aged ≥ 18 and ≤ 70 years at the time of signing informed consent.
* Body mass index 27 ≥ and ≤ 45 kg/m\^2 at screening.
* Diagnosis of T2DM at least 6 months before screening based on the WHO classification.
* Treatment of T2DM for at least 3 months prior to screening with diet and exercise and a stable dose of metformin (either immediate release or extended release), with or without a stable dose of 1 additional OAM other than metformin.

* Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma, or any other type of diabetes mellitus (except T2DM or history of gestational diabetes).
* History of proliferative diabetic retinopathy or diabetic macular edema or nonproliferative diabetic retinopathy that requires acute treatment.
* One or more episodes of severe hypoglycemia (Level 3 hypoglycemia as defined by the American Diabetes Association classification criteria7 ) within 6 months before screening, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery.
* Has modified diet or adopted any nutritional lifestyle modifications within 3 months prior to screening, as assessed by the investigator (or designee) based on participant self-report
* History of malignancy within the last 5 years before screening (except nonmelanoma skin cancers, cervical carcinoma in situ, or breast ductal carcinoma in situ).
* Family (first-degree relative\[s\]) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2).
* History or evidence of endocrine disorder (such as Cushing's syndrome) that can cause obesity.
* History or evidence of autoimmune disease that can directly or indirectly affect insulin production, insulin action, or glucose metabolism.
* History of any of the following within 90 days before screening: myocardial infarction, unstable angina, coronary artery bypass graft surgery or other major cardiovascular surgery, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, cerebrovascular accident, or decompensated congestive heart failure, or currently have New York Heart Association Class III or IV heart failure.
* History of chronic pancreatitis.
* History of acute pancreatitis within 6 months before screening.
* Positive human immunodeficiency virus test at screening.
* Evidence of hepatitis B or C infection based on 1 or more of the following results and/or criteria at screening
* Estimated glomerular filtration rate \< 60 mL/min/1.73 m2 calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration creatinine-cystatin C equation at screening or check-in (Day -4).
* Hemoglobin value \< 12 g/dL (males) or \< 11 g/dL (females) at screening or check-in (Day -4).
* Use within 90 days before randomization of medications, supplements, or alternative remedies for weight loss (eg, GLP-1RA, GIP agonists, phentermine/topiramate, naltrexone/bupropion, orlistat, and sympathomimetic drugs).
* Use within 90 days before randomization of chronic (\> 14 days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intraarticular, or inhaled preparations).
* Use within 90 days before randomization of medications that may cause significant weight gain including, but not limited to, tricyclic antidepressants, atypical antipsychotic, and mood stabilizers.
* Current or prior use of herbal supplements that affect insulin or glucose within 30 days before randomization.
* Currently receiving treatment in another investigational device or drug study, or less than 30 days (or 5 half-lives, whichever is longer) since ending treatment on another investigational device or drug study(ies).
* Participants of childbearing potential unwilling to adhere to contraception requirements during treatment and for an additional 16 weeks after the last dose of IMP.
* Participants who are breastfeeding or who plan to breastfeed while on study through 16 weeks after the last dose of IMP.
* Participants planning to become pregnant while on study through 16 weeks after the last dose of IMP.
* Major surgical procedure planned during the study.
* Participant has known sensitivity to any of the products or components to be administered during dosing.
* Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge.
* History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the investigator or medical monitor, if consulted as necessary, would pose a risk to participant's safety or interfere with the study evaluation, procedures, or completion.

Contacts and Locations

Study Contact

Amgen Call Center

CONTACT

866-572-6436

medinfo@amgen.com

Principal Investigator

STUDY_DIRECTOR

Amgen

Study Locations (Sites)

ProSciento

Chula Vista, California, 91911

United States

Collaborators and Investigators

Sponsor: Amgen

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-09

Study Completion Date2026-12-13

Study Record Updates

Study Start Date2025-09-09

Study Completion Date2026-12-13

Terms related to this study

Keywords Provided by Researchers

Type 2 Diabetes Mellitus
T2DM
Maridebart Cafraglutide
AMG 133
Insulin sensitivity
β-cell Function

Additional Relevant MeSH Terms

Type 2 Diabetes Mellitus