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Active, not recruitingNCT07160257Updated Jun 12, 2026

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

A Phase 1 interventional study of Maridebart cafraglutide and Placebo in Type 2 Diabetes Mellitus, sponsored by Amgen. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Amgen · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Type 2 Diabetes Mellitus
  • T2DM
  • Maridebart Cafraglutide
  • AMG 133
  • Insulin sensitivity
  • β-cell Function
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 56 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion 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 ≥ 23.0 kg/m\^2 (Asian participants only) or ≥ 25 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.

Exclusion criteria

Exclusion Criteria:

  • 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 criteria) 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.
  • Estimated glomerular filtration rate \< 60 mL/min/1.73 m\^2 calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration creatinine-cystatin C equation at screening.
  • Hemoglobin value \< 12 g/dL (males) or \< 10 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, 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Maridebart cafraglutide

    Participants will receive maridebart cafraglutide subcutaneously (SC).

    Drug: Maridebart cafraglutide

  • Placebo comparator
    Placebo

    Participants will receive placebo SC.

    Drug: Placebo

Interventions

  • DrugMaridebart cafraglutide

    Maridebart cafraglutide will be administered SC.

    Also known as: AMG 133

  • DrugPlacebo

    Placebo will be administered SC.

06

What researchers measure

Primary outcomes

  1. Change from Baseline in M-value from Hyperinsulinemic-euglycemic Clamp at Week 25

    Time frame: Baseline and Week 25

Secondary outcomes

  1. Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events

    Time frame: Up to Week 41

  2. Plasma Concentration of Maridebart Cafraglutide at Week 25

    Time frame: Week 25

  3. Number of Participants with Anti-maridebart Cafraglutide Antibody Formation

    Time frame: Up to Week 41

  4. Change from Baseline in Total Insulin Secretion at Week 25

    Measured as area under the curve (AUC) of insulin secretion rate (ISR) from hyperglycemic clamp (ISR0-120min).

    Time frame: Baseline and Week 25

  5. Change from Baseline in First Phase Incremental ISR from Hyperglycemic Clamp (ISR0-8min) at Week 25

    Time frame: Baseline and Week 25

  6. Change from Baseline in Second Phase Insulin Secretion at Week 25

    Measured as AUC of ISR from hyperglycemic clamp (ISR20-120min).

    Time frame: Baseline and Week 25

  7. Change from Baseline in Maximum Insulin Secretion at 8 Minutes at Week 25

    Measured as incremental ISR responses to arginine from hyperglycemic clamp at 8 minutes (ISRarg0-8min).

    Time frame: Baseline and Week 25

  8. Change from Baseline in Maximum Insulin Secretion at 30 Minutes at Week 25

    Measured as incremental ISR responses to arginine from hyperglycemic clamp at 30 minutes (ISRarg0-30min).

    Time frame: Baseline and Week 25

  9. Change from Baseline in ISR at Week 25

    Measured as total AUC (ISR0-240min) from standardized mixed meal tolerance test (sMMTT).

    Time frame: Baseline and Week 25

  10. Change from Baseline in Clamp Disposition Index (cDI) at Week 25

    Calculated as product of M-value and ISR0-120min from the hyperglycemic clamp.

    Time frame: Baseline and Week 25

  11. Change from Baseline in Post-meal Glucose Concentrations During sMMTT (Total and Incremental AUC0-240min) at Week 25

    Time frame: Baseline and Week 25

  12. Change from Baseline in Hemoglobin A1c (HbA1c) at Week 25

    Time frame: Baseline and Week 25

  13. Change from Baseline in Fasting Glucose Concentration at Week 25

    Time frame: Baseline and Week 25

  14. Change from Baseline in Fasting Glucagon Concentration at Week 25

    Time frame: Baseline and Week 25

  15. Change from Baseline in Glucagon Concentration During sMMTT (Total and Incremental AUC0-240min) at Week 25

    Time frame: Baseline and Week 25

  16. Change from Baseline in Fasting Triglycerides at Week 25

    Time frame: Baseline and Week 25

  17. Change from Baseline in Fasting High-density Lipoprotein-cholesterol (HDL-C) at Week 25

    Time frame: Baseline and Week 25

  18. Change from Baseline in Fasting Non-HDL-C at Week 25

    Time frame: Baseline and Week 25

  19. Change from Baseline in Triglyceride Concentration During sMMTT (Total and Incremental AUC0-240min) at Week 25

    Time frame: Baseline and Week 25

  20. Change from Baseline in Fasting Free Fatty Acids (FFA) Concentration (During Hyperinsulinemic-euglycemic Clamp and sMMTT) at Week 25

    Time frame: Baseline and Week 25

  21. Change from Baseline in FFA Concentrations During sMMTT (Total AUC0-240min) at Week 25

    Time frame: Baseline and Week 25

  22. Change from Baseline in Percentage Body Fat at Week 25

    Time frame: Baseline and Week 25

  23. Change from Baseline in Body Fat Mass at Week 25

    Time frame: Baseline and Week 25

  24. Change from Baseline in Lean Body Mass at Week 25

    Time frame: Baseline and Week 25

  25. Change from Baseline in Body Weight at Week 25

    Time frame: Baseline and Week 25

  26. Change from Baseline in Waist Circumference at Week 25

    Time frame: Baseline and Week 25

  27. Change from Baseline in Hunger Fasting Appetite Visual Analog Scale (VAS) Score at Week 25

    Time frame: Baseline and Week 25

  28. Change from Baseline in Satiety Fasting Appetite VAS Score at Week 25

    Time frame: Baseline and Week 25

  29. Change from Baseline in Fullness Fasting Appetite VAS Score at Week 25

    Time frame: Baseline and Week 25

  30. Change from Baseline in Prospective Food Consumption Fasting Appetite VAS Score at Week 25

    Time frame: Baseline and Week 25

  31. Change from Baseline in Overall Fasting Appetite VAS Score at Week 25

    Time frame: Baseline and Week 25

  32. Change from Baseline in Hunger Appetite VAS Score During sMMTT at Week 25

    Time frame: Baseline and Week 25

  33. Change from Baseline in Satiety Appetite VAS Score During sMMTT at Week 25

    Time frame: Baseline and Week 25

  34. Change from Baseline in Fullness Appetite VAS Score During sMMTT at Week 25

    Time frame: Baseline and Week 25

  35. Change from Baseline in Prospective Food Consumption Appetite VAS Score During sMMTT at Week 25

    Time frame: Baseline and Week 25

  36. Change from Baseline in Overall Appetite VAS Score During sMMTT at Week 25

    Time frame: Baseline and Week 25

  37. Change from Baseline in Food Craving Inventory (FCI) Score at Week 25

    Time frame: Baseline and Week 25

  38. Change from Baseline in Caloric Intake During Ad Libitum Meal at Week 25

    Time frame: Baseline and Week 25

07

Study locations

1 site
  • ProSciento, Inc. - Main Clinic
    Chula Vista, California 91911-1350, United States
08

References and documents

Individual participant data

Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting information: Study protocol, Sap, Icf, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07160257
Lead sponsor
Amgen
Responsible party
Sponsor
First posted
Sep 8, 2025
Start date
Aug 5, 2025
Primary completion
Nov 15, 2026 (estimated)
Completion
Mar 4, 2027 (estimated)
Last update
Jun 12, 2026

Study contacts

MD
study director · Amgen

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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