Diabetes Mellitus, Type 2, Obesity, Overweight
Conditions
Keywords
Type 2 Diabetes Mellitus, T2DM, BMI, Obesity, Overweight, Maridebart Cafraglutide, MariTide, Chronic Weight Management, Extension, Long-Term
Brief summary
The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity and type 2 diabetes mellitus. Trial 20210182 is extension of trial 20210184 (NCT06858878).
Interventions
Administered subcutaneously.
DRUGPlacebo
Administered subcutaneously.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Signed informed consent form (ICF) indicating compliance with the requirements and restrictions listed in the ICF and this protocol. * Participants completing Study 20210184 must meet the following criteria: * Completed the Week 72 visit in Study 20210184. * Did not permanently discontinue the investigational product in the parent trial (20210184). * Randomized within 7 days of week 72 visit in the parent trial. * Participants must use protocol-specified contraception during treatment and for 16 weeks after the last dose of trial intervention.
Exclusion criteria
* Planned (during the trial) surgical, endoscopic, or device-based treatment for obesity. * Body mass index (BMI) ≤ 18.5 kilograms per meter square (kg/m\^2). * Participant has known sensitivity to any of the products or components to be administered during dosing. * History of ischemic optic neuropathy. * Any malignancy diagnosed during the parent trial, except for the following treated with curative intent: * Nonmelanoma skin cancers * Breast ductal carcinoma in situ * Cervical carcinoma in situ * Prostate cancer in situ * Newly identified (during the parent trial) multiple endocrine neoplasia syndrome type 2, or family history (first-degree relative\[s\]) history of medullary thyroid carcinoma (MTC). * Patient Health Questionnaire-9 (PHQ-9) score ≥ 15 at the Week 72 visit from the parent trial (20210184) before randomization. * Any suicidal ideation (category 4 or 5) or any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS), Since Last Visit version, at the Week 72 visit from the parent trial before randomization. * Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements, in the judgment of the individual and investigator. * History or evidence of any other clinically significant disorder, condition, disease (including, but not limited to known drug or alcohol abuse, eating disorders, and conditions identified during the parent trial) that, in the opinion of the investigator, would pose a risk to participant safety. * Currently pregnant (confirmed with positive pregnancy test) or breastfeeding or planning to become pregnant or breastfeed while on trial until an additional 16 weeks after the last dose of trial intervention. * Major surgical procedures planned during the trial. * Participants with minor surgical procedures (not requiring general anesthesia or deep sedation) planned during the trial may be eligible at the discretion of the investigator. * Investigative site personnel directly affiliated with the trial and/or their immediate family (ie, spouse, parent, child, or sibling, whether biological or legally adopted).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change in Body Weight from Baseline of the Parent Trial (20210184) | Baseline of parent trial (20210184) to Week 48 of current trial |
| Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Baseline of current trial up to 60 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving ≥ 5% Reduction in Body Weight from Baseline of the Parent Trial | Baseline of parent trial to Week 48 of current trial |
| Percentage of Participants Achieving ≥ 10% Reduction in Body Weight from Baseline of the Parent Trial | Baseline of parent trial to Week 48 of current trial |
| Percentage of Participants Achieving ≥ 15% Reduction in Body Weight from Baseline of the Parent Trial | Baseline of parent trial to Week 48 of current trial |
| Percentage of Participants Achieving ≥ 20% Reduction in Body Weight from Baseline of the Parent Trial | Baseline of parent trial to Week 48 of current trial |
| Change from Baseline of the Parent Trial in Hemoglobin A1c | Baseline of parent trial to Week 48 of current trial |
| Change from Baseline of the Parent Trial in Waist Circumference | Baseline of parent trial to Week 48 of current trial |
| Change from Baseline of the Parent Trial in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score | Baseline of parent trial to Week 48 of current trial |
| Percent Change from Baseline in Body Weight | Baseline of current trial to Week 48 |
| Percentage of Participants with No Body Weight Gain of >3% From Baseline | Week 48 of current trial |
| Percentage of Participants with No Body Weight Gain of >5% From Baseline | Week 48 of current trial |
| Percentage of Body Weight Reduction Maintained from the Parent Trial | Baseline of parent trial to Week 48 of current trial |
| Percentage of Participants Maintaining ≥ 80% of the Body Weight Reduction Achieved in the Parent Trial | Baseline of parent trial to Week 48 of current trial |
| Change from Baseline in HbA1c | Week 48 of current trial |
Contacts
CONTACTAmgen Call Center
STUDY_DIRECTORMD
Amgen
Outcome results
None listed