Clinical Trials in Italy / NCT06914895
Active, not recruiting
Phase 3
A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight
NCT06914895 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Type 1 DiabetesObesityOverweight
Investigational drug(s) / intervention(s)
Tirzepatide →Placebo
Tirzepatide: Administered SC
Placebo: Administered SC
Study summary
The main purpose of this study is to find out how well and how safely tirzepatide works in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 49 weeks.
Eligibility
Inclusion Criteria:
* Have type 1 diabetes and on insulin treatment for at least one year prior to screening
* Have an HbA1c value of 7.0% to 10.5% inclusive, at screening
* Have a body mass index (BMI) of ≥25 kilograms per square meter (kg/m2) at screening
* Are of stable weight for at least 90 days prior to screening and agree to not start an intensive diet or exercise program during the study
Exclusion Criteria:
* Have experienced two or more events requiring hospitalization due to poor glucose control (hyperglycemia or (diabetic ketoacidosis (DKA)) during the period of 180 days prior to screening and until randomization.
* Have experienced one or more events of severe hypoglycemia during the period of 90 days prior to screening and until randomization.
* Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
* Have had chronic or acute pancreatitis
* Have used any weight loss drugs or alternative remedies, including herbal or nutritional supplements, within 90 days prior to screening
Primary outcome measure(s)
- Change from Baseline in Hemoglobin A1c (HbA1c) — Baseline, Week 40
Trial sites (146)
| Facility | City | Region | Status |
|---|---|---|---|
| Sansum Diabetes Research Institute | Santa Barbara | California | |
| Care Access - Santa Clarita | Santa Clarita | California | |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | |
| Atlanta Diabetes Associates | Atlanta | Georgia | |
| Orita Clinical Research | Decatur | Georgia | |
| North Georgia Clinical Research | Woodstock | Georgia | |
| East-West Medical Research Institute | Honolulu | Hawaii | |
| Rocky Mountain Clinical Research | Idaho Falls | Idaho | |
| Southern Illinois University School of Medicine | Springfield | Illinois | |
| Indiana University Health University Hospital | Indianapolis | Indiana | |
| Iowa Diabetes and Endocrinology Research Center | West Des Moines | Iowa | |
| Endocrine and Metabolic Consultants | Rockville | Maryland | |
| HealthPartners Institute dba International Diabetes Center | Minneapolis | Minnesota | |
| SKY Integrative Medical Center/SKYCRNG | Ridgeland | Mississippi | |
| Boeson Research MSO | Missoula | Montana | |
| Palm Research Center Tenaya | Las Vegas | Nevada | |
| Palm Research Center Sunset | Las Vegas | Nevada | |
| Albany Medical College, Division of Community Endocrinology | Albany | New York | |
| Research Foundation of SUNY - University of Buffalo | Buffalo | New York | |
| NYC Research | New York | New York | |
| SUNY Upstate Medical University | Syracuse | New York | |
| Lucas Research, Inc. | Morehead City | North Carolina | |
| Care Access - Lima | Lima | Ohio | |
| Alliance for Multispecialty Research, LLC | Norman | Oklahoma | |
| Suburban Research Associates | West Chester | Pennsylvania | |
| Texas Diabetes & Endocrinology, P.A. | Austin | Texas | |
| Velocity Clinical Research, Dallas | Dallas | Texas | |
| Tekton Research, LLC. | McKinney | Texas | |
| Medrasa Clinical Research | Wylie | Texas | |
| Eastside Research Associates | Redmond | Washington | |
| Rainier Clinical Research Center | Renton | Washington | |
| Investigaciones Medicas Imoba Srl | Buenos Aires | Argentina | |
| Centro de Investigaciones Metabólicas (CINME) | Buenos Aires | Argentina | |
| CIPREC | Buenos Aires | Argentina | |
| Consultorio de Investigación Clínica EMO SRL | Buenos Aires | Argentina | |
| CENUDIAB | Buenos Aires | Argentina | |
| Instituto de Investigaciones Clínicas Córdoba | Córdoba | Argentina | |
| Centro Medico Privado San Vicente Diabetes | Córdoba | Argentina | |
| Centro de Investigaciones Médicas Mar del Plata | Mar del Plata | Argentina | |
| Instituto Médico Río Cuarto | Río Cuarto | Argentina |
+ 106 more sites — see the full list on the official registry below.
On this site
📄 Mounjaro (tirzepatide) drug profile →More Eli Lilly and Company trials in Italy
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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 NCT06914895 on ClinicalTrials.gov ↗ ← All trials in Italy