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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
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).
Primary outcome measure(s)
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
Trial sites (37)
Facility
City
Region
Status
Gilbert Center for Family Medicine
Gilbert
Arizona
Recruiting
San Fernando Valley Health Institute
Canoga Park
California
Recruiting
Core Healthcare Group
Cerritos
California
Recruiting
Velocity Clinical Research Chula Vista
Chula Vista
California
Recruiting
Empire Clinical Research
Pomona
California
Recruiting
Optimus U Corporation
Miami
Florida
Recruiting
San Marcus Research Clinic Inc
Miami Lakes
Florida
Recruiting
Indago Research and Health Center
Miami Lakes
Florida
Recruiting
Florida Institute for Clinical Research
Orlando
Florida
Recruiting
Encore Medical Research of Weston LLC
Weston
Florida
Recruiting
Conquest Research - Winter Park
Winter Park
Florida
Recruiting
Iowa Diabetes Research
West Des Moines
Iowa
Recruiting
Alliance for Multispecialty Research Newton
Newton
Kansas
Recruiting
Alliance for Multispecialty Research LLC
Wichita
Kansas
Recruiting
Alliance for Multispecialty Research - Kansas City
Kansas City
Missouri
Recruiting
Palm Research Center Inc
Las Vegas
Nevada
Recruiting
Premier Research
Trenton
New Jersey
Recruiting
West Clinical Research
Morehead City
North Carolina
Recruiting
Velocity Clinical Research - Cincinnati
Cincinnati
Ohio
Recruiting
Velocity Clinical Research - Springdale
Cincinnati
Ohio
Recruiting
Velocity Clinical Research - Providence
East Greenwich
Rhode Island
Recruiting
Elligo Clinical Research Center
Austin
Texas
Recruiting
Johnson County Clinical Trials Juno Bellaire
Bellaire
Texas
Recruiting
Osvaldo A Brusco MD PA
Corpus Christi
Texas
Recruiting
Soma Clinical Trials, LLC
Denison
Texas
Recruiting
JCCT- Juno Northwest Houston
Houston
Texas
Recruiting
Manassas Clinical Research Center Inc
Manassas
Virginia
Recruiting
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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