DRUG
Maridebart cafraglutide
Administered subcutaneously
Status
Not yet recruiting
Phase
Phase 3
Enrollment
3,200
Locations
0
Results
Not posted
Publications
0
Study summary
The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity or overweight. Trial 20250197 is an extension of trial 20210181 (NCT06858839).
Interventions
DRUG
Administered subcutaneously
DRUG
Administered subcutaneously.
Timeline
First posted
Jul 6, 2026
Study start
Jul 29, 2026
Primary completion
Dec 26, 2027
Study completion
Mar 19, 2028
Results posted
Not reported
Registry updated
Jul 6, 2026
Outcomes
Percent Change in Body Weight from Baseline of the Parent Trial (20210181)
Time frame · Baseline of parent trial (20210181) to Week 48 of current trial
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame · Baseline of current trial up to 60 weeks
Percentage of Participants Achieving ≥5% Reduction in Body Weight from Baseline of the Parent Trial
Time frame · 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
Time frame · 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
Time frame · 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
Time frame · Baseline of parent trial to Week 48 of current trial
Change from Baseline of the Parent Trial in Waist Circumference
Time frame · 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
Time frame · Baseline of parent trial to Week 48 of current trial
Percent Change from Baseline in Body Weight
Time frame · Baseline of current trial to Week 48
Percentage of Participants with No Body Weight Gain of >3% From Baseline
Time frame · Week 48 of current trial
Percentage of Participants with No Body Weight Gain of >5% From Baseline
Time frame · Week 48 of current trial
Percentage of Body Weight Reduction Maintained from the Parent Trial
Time frame · Baseline of parent trial to Week 48 of current trial
Eligibility
Inclusion Criteria: * Signed informed consent form (ICF) which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. * Completed the parent trial (2010181) * Completed week 72 visit in parent trial * Did not permanently discontinue trial intervention in parent trial * Randomized within 7 Days of week 72 visit in the parent trial * Participants must use protocol-specified contraception during treatment, and for an additional 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 ≤ 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 parent trial (20210181) except for the following treated with curative intent: nonmelanoma skin cancers, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ. * Newly identified (i.e., identified during 20210181) multiple endocrine neoplasia syndrome type 2 or family (first-degree relative\[s\]) history of medullary thyroid cancer. * Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15 at week 72 visit from parent trial before randomization * Any suicidal ideation of category 4 or 5 OR any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit version at week 72 visit from 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, or 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).
Study locations
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
Publications
No PMID-linked publications were present in this registry snapshot.
Related trials
Amgen · Atherosclerotic Cardiovascular Disease · Overweight
Phase 3
Recruiting
12,800
2026-07
Amgen · Obesity or Overweight
Phase 3
Recruiting
300
2026-07
Amgen · Overweight and Obesity
Phase 1
Completed
154
2026-07
Amgen · Overweight · Obesity
Phase 1
Active, not recruiting
49
2026-07
Amgen · Overweight and Obesity
Phase 1
Completed
349
2026-07
Amgen · Obesity · Overweight
Phase 3
Not yet recruiting
950
2026-07
Amgen · Heart Failure With Preserved Ejection Fraction · Heart Failure With Mildly Reduced Ejection Fraction
Phase 3
Recruiting
5,056
2026-07
Amgen · Overweight or Obesity and Elevated Liver Fat
Phase 2
Recruiting
180
2026-06
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.