Type 2 Diabetes MellitusPhase 1NCT07160257
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 study testing Maridebart cafraglutide in people with Type 2 Diabetes Mellitus, run by Amgen at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Maridebart cafraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2025to 4 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 27Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
ProSciento, Inc. - Main Clinic
Chula Vista, California, 91911-1350
About this study
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
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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Maridebart cafraglutide, Placebo
- Keywords
- Type 2 Diabetes Mellitus, T2DM, Maridebart Cafraglutide, AMG 133, Insulin sensitivity, β-cell Function
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maridebart cafraglutideDrug
Also called AMG 133
Maridebart cafraglutide will be administered SC.
PlaceboDrug
Placebo will be administered SC.
| Study group | Role | What they receive |
|---|---|---|
| Maridebart cafraglutide | Experimental | Participants will receive maridebart cafraglutide subcutaneously (SC). Receives: Drug: Maridebart cafraglutide |
| Placebo | Placebo comparator | Participants will receive placebo SC. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in M-value from Hyperinsulinemic-euglycemic Clamp at Week 25
Measured: Baseline and Week 25
Secondary outcomes (38)
Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events
Measured: Up to Week 41
Plasma Concentration of Maridebart Cafraglutide at Week 25
Measured: Week 25
Number of Participants with Anti-maridebart Cafraglutide Antibody Formation
Measured: Up to Week 41
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).
Measured: Baseline and Week 25
Change from Baseline in First Phase Incremental ISR from Hyperglycemic Clamp (ISR0-8min) at Week 25
Measured: Baseline and Week 25
Change from Baseline in Second Phase Insulin Secretion at Week 25
Measured as AUC of ISR from hyperglycemic clamp (ISR20-120min).
Measured: Baseline and Week 25
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).
Measured: Baseline and Week 25
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).
Measured: Baseline and Week 25
Change from Baseline in ISR at Week 25
Measured as total AUC (ISR0-240min) from standardized mixed meal tolerance test (sMMTT).
Measured: Baseline and Week 25
Change from Baseline in Clamp Disposition Index (cDI) at Week 25
Calculated as product of M-value and ISR0-120min from the hyperglycemic clamp.
Measured: Baseline and Week 25
Change from Baseline in Post-meal Glucose Concentrations During sMMTT (Total and Incremental AUC0-240min) at Week 25
Measured: Baseline and Week 25
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 25
Measured: Baseline and Week 25
Change from Baseline in Fasting Glucose Concentration at Week 25
Measured: Baseline and Week 25
Change from Baseline in Fasting Glucagon Concentration at Week 25
Measured: Baseline and Week 25
Change from Baseline in Glucagon Concentration During sMMTT (Total and Incremental AUC0-240min) at Week 25
Measured: Baseline and Week 25
Change from Baseline in Fasting Triglycerides at Week 25
Measured: Baseline and Week 25
Change from Baseline in Fasting High-density Lipoprotein-cholesterol (HDL-C) at Week 25
Measured: Baseline and Week 25
Change from Baseline in Fasting Non-HDL-C at Week 25
Measured: Baseline and Week 25
Change from Baseline in Triglyceride Concentration During sMMTT (Total and Incremental AUC0-240min) at Week 25
Measured: Baseline and Week 25
Change from Baseline in Fasting Free Fatty Acids (FFA) Concentration (During Hyperinsulinemic-euglycemic Clamp and sMMTT) at Week 25
Measured: Baseline and Week 25
Change from Baseline in FFA Concentrations During sMMTT (Total AUC0-240min) at Week 25
Measured: Baseline and Week 25
Change from Baseline in Percentage Body Fat at Week 25
Measured: Baseline and Week 25
Change from Baseline in Body Fat Mass at Week 25
Measured: Baseline and Week 25
Change from Baseline in Lean Body Mass at Week 25
Measured: Baseline and Week 25
Change from Baseline in Body Weight at Week 25
Measured: Baseline and Week 25
Change from Baseline in Waist Circumference at Week 25
Measured: Baseline and Week 25
Change from Baseline in Hunger Fasting Appetite Visual Analog Scale (VAS) Score at Week 25
Measured: Baseline and Week 25
Change from Baseline in Satiety Fasting Appetite VAS Score at Week 25
Measured: Baseline and Week 25
Change from Baseline in Fullness Fasting Appetite VAS Score at Week 25
Measured: Baseline and Week 25
Change from Baseline in Prospective Food Consumption Fasting Appetite VAS Score at Week 25
Measured: Baseline and Week 25
Change from Baseline in Overall Fasting Appetite VAS Score at Week 25
Measured: Baseline and Week 25
Change from Baseline in Hunger Appetite VAS Score During sMMTT at Week 25
Measured: Baseline and Week 25
Change from Baseline in Satiety Appetite VAS Score During sMMTT at Week 25
Measured: Baseline and Week 25
Change from Baseline in Fullness Appetite VAS Score During sMMTT at Week 25
Measured: Baseline and Week 25
Change from Baseline in Prospective Food Consumption Appetite VAS Score During sMMTT at Week 25
Measured: Baseline and Week 25
Change from Baseline in Overall Appetite VAS Score During sMMTT at Week 25
Measured: Baseline and Week 25
Change from Baseline in Food Craving Inventory (FCI) Score at Week 25
Measured: Baseline and Week 25
Change from Baseline in Caloric Intake During Ad Libitum Meal at Week 25
Measured: Baseline and Week 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start5 Aug 2025
- Primary completion15 Nov 2026 (estimated)
- Study completion4 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160257
- Sponsor's protocol ID
- 20250061
- Status last verified
- Jun 2026
- First submitted
- 29 Aug 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07160257
- Acronym / sponsor ID
- 20250061
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, T2DM, Maridebart Cafraglutide, AMG 133, Insulin sensitivity, β-cell Function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 4 Mar 2027 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maridebart cafraglutide | Experimental | Drug: Maridebart cafraglutideParticipants will receive maridebart cafraglutide subcutaneously (SC). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo SC. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (27 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maridebart cafraglutideAlso: AMG 133Maridebart cafraglutide will be administered SC. | Drug | Maridebart cafraglutide |
| PlaceboPlacebo will be administered SC. | Drug | Placebo |
Primary outcome
Change from Baseline in M-value from Hyperinsulinemic-euglycemic Clamp at Week 25
Time frame: Baseline and Week 25
38 secondary outcomes
Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events
Time frame: Up to Week 41
Plasma Concentration of Maridebart Cafraglutide at Week 25
Time frame: Week 25
Number of Participants with Anti-maridebart Cafraglutide Antibody Formation
Time frame: Up to Week 41
Change from Baseline in Total Insulin Secretion at Week 25
Time frame: Baseline and Week 25
Change from Baseline in First Phase Incremental ISR from Hyperglycemic Clamp (ISR0-8min) at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Second Phase Insulin Secretion at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Maximum Insulin Secretion at 8 Minutes at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Maximum Insulin Secretion at 30 Minutes at Week 25
Time frame: Baseline and Week 25
Change from Baseline in ISR at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Clamp Disposition Index (cDI) at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Post-meal Glucose Concentrations During sMMTT (Total and Incremental AUC0-240min) at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Fasting Glucose Concentration at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Fasting Glucagon Concentration at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Glucagon Concentration During sMMTT (Total and Incremental AUC0-240min) at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Fasting Triglycerides at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Fasting High-density Lipoprotein-cholesterol (HDL-C) at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Fasting Non-HDL-C at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Triglyceride Concentration During sMMTT (Total and Incremental AUC0-240min) at Week 25
Time frame: Baseline and Week 25
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
Change from Baseline in FFA Concentrations During sMMTT (Total AUC0-240min) at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Percentage Body Fat at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Body Fat Mass at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Lean Body Mass at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Body Weight at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Waist Circumference at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Hunger Fasting Appetite Visual Analog Scale (VAS) Score at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Satiety Fasting Appetite VAS Score at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Fullness Fasting Appetite VAS Score at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Prospective Food Consumption Fasting Appetite VAS Score at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Overall Fasting Appetite VAS Score at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Hunger Appetite VAS Score During sMMTT at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Satiety Appetite VAS Score During sMMTT at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Fullness Appetite VAS Score During sMMTT at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Prospective Food Consumption Appetite VAS Score During sMMTT at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Overall Appetite VAS Score During sMMTT at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Food Craving Inventory (FCI) Score at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Caloric Intake During Ad Libitum Meal at Week 25
Time frame: Baseline and Week 25
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Maridebart cafraglutide in people with Type 2 Diabetes Mellitus, run by Amgen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in M-value from Hyperinsulinemic-euglycemic Clamp at Week 25 (time frame: Baseline and Week 25). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.