A Phase 3, Randomized, Double-Blind Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Participants With Obesity or Overweight
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Amgen
- Enrollment
- 3,200
- Locations
- 87
- Primary Endpoint
- Percent Change in Body Weight from Baseline of the Parent Trial (20210181)
Study Overview
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 or overweight. Trial 20250197 is an extension of trial 20210181 (NCT06858839).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Maridebart Cafraglutide High Dose Q4W (Received Placebo in the Parent Trial)
Participants who received placebo in the parent trial will receive high dose of maridebart cafraglutide SC Q4W. Prior to initiating the assigned high dose, participants will undergo a dose-escalation phase gradually increasing doses.
Intervention: Maridebart cafraglutide (Drug)
Placebo Q4W (Received Medium Dose Maridebart Cafraglutide in Parent Trial)
Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W.
Intervention: Placebo (Drug)
Maridebart Cafraglutide High Dose Q4W
Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q4W.
Intervention: Maridebart cafraglutide (Drug)
Maridebart Cafraglutide Low Dose Q4W(Received Very Low Dose Maridebart Cafraglutide in Parent Trial)
Participants who permanently de-escalated to very low dose of maridebart cafraglutide in the parent trial will receive low dose of maridebart cafraglutide SC Q4W.
Intervention: Maridebart cafraglutide (Drug)
Maridebart Cafraglutide Medium Dose Q4W
Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC Q4W.
Intervention: Maridebart cafraglutide (Drug)
Maridebart Cafraglutide Low Dose Q4W
Participants who received low dose of maridebart cafraglutide in the parent trial (20210181 [NCT06858839]) will continue to receive low dose of maridebart cafraglutide subcutaneously (SC) once in 4 weeks(Q4W).
Intervention: Maridebart cafraglutide (Drug)
Maridebart Cafraglutide Medium Dose Q8W
Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC once in 8weeks (Q8W).
Intervention: Maridebart cafraglutide (Drug)
Maridebart Cafraglutide High Dose Q8W
Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q8W.
Intervention: Maridebart cafraglutide (Drug)
Maridebart Cafraglutide High Dose Q12W
Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC once in 12 weeks (Q12W).
Intervention: Maridebart cafraglutide (Drug)
Placebo Q4W (Received High Dose Maridebart Cafraglutide in Parent Trial)
Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W.
Intervention: Placebo (Drug)
Outcomes
Primary 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
Secondary Outcomes
- 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 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)