Clinical Trials in Italy / NCT06858878
Active, not recruiting
Phase 3
Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight
NCT06858878 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Investigational drug(s) / intervention(s)
Maridebart cafraglutide →Placebo
Maridebart cafraglutide: Maridebart cafraglutide will be adminstered SC.
Placebo: Placebo will be adminstered SC.
Study summary
The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.
Eligibility
Inclusion Criteria:
* Age ≥ 18 years.
* Body mass index ≥ 27 kg/m\^2.
* History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
* Diagnosis of T2DM.
Exclusion Criteria:
* Type 1 diabetes mellitus.
* Self-reported change in body weight \> 5 kg within 90 days before screening.
* Proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment.
* Obesity induced by other endocrinologic disorders.
* Family (first-degree relative\[s\]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.
* History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening.
* History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
* Lifetime history of suicide attempt.
Primary outcome measure(s)
- Percent Change from Baseline in Body Weight at Week 72 — Baseline and Week 72
Trial sites (187)
| Facility | City | Region | Status |
|---|---|---|---|
| Alliance for Multispecialty Research Mobile | Mobile | Alabama | |
| Gilbert Center for Family Medicine | Gilbert | Arizona | |
| Desert Clinical Research | Mesa | Arizona | |
| Avacare Foothills Research Center | Phoenix | Arizona | |
| San Fernando Valley Health Institute | Canoga Park | California | |
| Core Healthcare Group | Cerritos | California | |
| Velocity Clinical Research Chula Vista | Chula Vista | California | |
| Headlands Research California | Escondido | California | |
| Paradigm Clinical Research | Modesto | California | |
| Flourish Research | Northridge | California | |
| University of California Irvine | Orange | California | |
| Empire Clinical Research | Pomona | California | |
| Infinity Clinical Trials | San Diego | California | |
| Greenwich Clinical Trials | Riverside | Connecticut | |
| Indago Research and Health Center | Hialeah | Florida | |
| Optimus U Corporation | Miami | Florida | |
| New Horizon Research Center | Miami | Florida | |
| San Marcus Research Clinic Inc | Miami Lakes | Florida | |
| Florida Institute for Clinical Research | Orlando | Florida | |
| Encore Medical Research of Weston LLC | Weston | Florida | |
| Conquest Research - Winter Park | Winter Park | Florida | |
| Alliance For Multispecialty Research - Oak Brook | Oak Brook | Illinois | |
| Alliance for Multispecialty Research, LLC - Park Ridge | Park Ridge | Illinois | |
| Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie | Skokie | Illinois | |
| Indiana Medical Research Institute | Merrillville | Indiana | |
| Iowa Diabetes Research | West Des Moines | Iowa | |
| Alliance for Multispecialty Research Newton | Newton | Kansas | |
| Alliance for Multispecialty Research LLC | Wichita | Kansas | |
| Advanced Internal Medicine | Paducah | Kentucky | |
| Ima Clinical Research- Monroe | Monroe | Louisiana | |
| Annapolis Internal Medicine, LLC | Annapolis | Maryland | |
| Brigham and Womens Hospital | Boston | Massachusetts | |
| International Diabetes Center - HealthPartners Institute | Minneapolis | Minnesota | |
| Alliance for Multispecialty Research - Kansas City | Kansas City | Missouri | |
| Palm Research Center Inc | Las Vegas | Nevada | |
| Vector Clinical Trials | Sparks | Nevada | |
| Premier Research | Trenton | New Jersey | |
| Albany Medical College | Albany | New York | |
| Asheville Clinical Research | Asheville | North Carolina | |
| Physicians East | Greenville | North Carolina |
+ 147 more sites — see the full list on the official registry below.
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Official registry record
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.
View NCT06858878 on ClinicalTrials.gov ↗ ← All trials in Italy