Clinical Trials in Italy / NCT06858839
Active, not recruiting
Phase 3
Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight
NCT06858839 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Obesity
Investigational drug(s) / intervention(s)
Maridebart Cafraglutide →Placebo
Maridebart Cafraglutide: Maridebart cafraglutide will be administered SC.
Placebo: Placebo will be administered 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 ≥ 30 kg/m2 or ≥27 kg/m² to \< 30 kg/m2 with at least 1 of the following weight-related comorbidities: hypertension, dyslipidemia, history of obstructive sleep apnea, history of cardiovascular disease, history of metabolic dysfunction-associated steatotic liver disease (MASLD) or Metabolic Dysfunction-Associated Steatohepatitis (MASH).
* History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
Exclusion Criteria:
* Type 1 or Typ2 diabetes mellitus.
* Obesity induced by other endocrinologic disorders.
* Self-reported change in body weight \> 5 kg within 90 days before screening.
* 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 (243)
| Facility | City | Region | Status |
|---|---|---|---|
| Pinnacle Research Group LLC | Anniston | Alabama | |
| Alliance For Multispecialty Research - Daphne | Daphne | Alabama | |
| Alliance for Multispecialty Research Mobile | Mobile | Alabama | |
| Avacare Foothills Research Center | Phoenix | Arizona | |
| Ark Clinical Research- Tustin | Fountain Valley | California | |
| Long Beach Clinical Trials Services Inc | Long Beach | California | |
| Ark Clinical Research- Long Beach | Long Beach | California | |
| Catalina Research Institute | Montclair | California | |
| Artemis Institute for Clinical Research | Riverside | California | |
| Artemis Institute for Clinical Research | San Diego | California | |
| Apex Clinical Research | San Diego | California | |
| Southern California Clinical Research | Santa Ana | California | |
| Diablo Clinical Research | Walnut Creek | California | |
| Yale School of Medicine | New Haven | Connecticut | |
| Chase Medical Research LLC | Waterbury | Connecticut | |
| Indago Research and Health Center | Hialeah | Florida | |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | |
| Clinical Neuroscience Solutions - Jacksonville | Jacksonville | Florida | |
| South Florida Wellness and Clinical Research Institute | Margate | Florida | |
| Optimus U Corporation | Miami | Florida | |
| Research Institute of South Florida | Miami | Florida | |
| Renstar Medical Research | Ocala | Florida | |
| Clinical Neuroscience Solutions - Orlando | Orlando | Florida | |
| Combined Research Orlando Phase I IV | Orlando | Florida | |
| Florida Institute for Clinical Research | Orlando | Florida | |
| Encore Medical Research of Weston LLC | Weston | Florida | |
| Center for Advanced Research and Education | Gainesville | Georgia | |
| Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group | Union City | Georgia | |
| East-West Medical Research | Honolulu | Hawaii | |
| Solaris Clinical Research | Meridian | Idaho | |
| Flourish Research - Great Lakes Clinical Trials | Chicago | Illinois | |
| Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie | Skokie | Illinois | |
| Evanston Premier Healthcare Research LLC | Skokie | Illinois | |
| Alliance for Multispecialty Research Newton | Newton | Kansas | |
| Louisville Metabolic and Atherosclerosis Research Center | Louisville | Kentucky | |
| Velocity Clinical Research - Baton Rouge | Baton Rouge | Louisiana | |
| Tandem Clinical Research - Marrero | Marrero | Louisiana | |
| Headlands Research - Detroit | Southfield | Michigan | |
| Prime Health and Wellness Sky Clinical Research Network Group | Fayette | Mississippi | |
| Alliance for Multispecialty Research - Kansas City | Kansas City | Missouri |
+ 203 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 NCT06858839 on ClinicalTrials.gov ↗ ← All trials in Italy