A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity

Obesity Clinical Trial

Official title:

A Phase 2, Randomized, Double-blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Investigational Tirzepatide Doses in Participants With Type 2 Diabetes and Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06037252
• Other study ID #: 18739
• Secondary ID: I8F-MC-GPIT2023-
• Status: Recruiting
• Phase: Phase 2
• Start date: September 21, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: June 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to learn more about the safety and efficacy of investigational tirzepatide doses in participants with Type 2 diabetes and obesity that are already taking metformin. The study will last for about 89 weeks.

Description:

The study will include a screening period of up to 5 weeks. The primary endpoint will be at Week 44 with a tirzepatide extension until week 80. A safety follow up will be performed approximately 4 weeks after end of treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: September 30, 2025
• Est. primary completion date: December 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria

• Have a Body Mass Index (BMI) =35 kilogram/square meter (kg/m²) at screening.

• Have had stable body weight (±5%) during the 90 days preceding screening.

• Have been diagnosed with Type 2 Diabetes (T2D).

• Have been on a stable treatment of metformin only at least 90 days preceding screening and between screening and randomization with the minimum effective dose of =1500 milligram (mg)/day.

Exclusion Criteria:

• Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.

• Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 6 months prior to screening.

• Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.

• Have a prior or planned surgical treatment for obesity.

• Use products intended for weight loss including prescription drugs, over the counter (OTC) drugs, and herbal preparations, within 3 months prior to screening.

• Have renal impairment measured as estimated glomerular filtration rate (eGFR) <45 milliliter/min (mL/min)/1.73 m².

• Have any of the following cardiovascular (CV) conditions within 2 months prior to screening.

• acute myocardial infarction.

• cerebrovascular accident (stroke).

• unstable angina .

• hospitalization due to congestive heart failure, or

• coronary artery revascularization.

• Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2.

• Have a history of chronic or acute pancreatitis.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Intervention

Drug:
• Tirzepatide
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Argentina	Centro Médico Viamonte	Buenos Aires	Ciudad Aut
Argentina	CEDIC	Caba	Buenos Aires
Argentina	Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada	Ciudad Autonoma de Buenos Aire	Ciudad Autónoma De Buenos Aire
Argentina	Consultorio de Investigación Clínica EMO SRL	Ciudad Autonoma de Buenos Aire	Ciudad Autónoma De Buenos Aire
Argentina	Centro de Investigaciones Metabólicas (CINME)	Ciudad Autónoma de Buenos Aire	Buenos Aires
Israel	Clalit Health Services - Atlit	Atlit	HaTsafon
Israel	Soroka Medical Center	Be'er Sheva	HaDarom
Israel	Bnai Zion Medical Center	Haifa	HaTsafon
Israel	Rambam Health Care Campus	Haifa	?eifa
Israel	Institute of Diabetes, Technology and Research - Clalit Health	Herzliya	HaMerkaz
Israel	Edith Wolfson Medical Center	Holon	HaMerkaz
Israel	Hadassah Medical Center	Jerusalem	Yerushalayim
Israel	Galilee Medical Center	Nahariya	HaTsafon
Israel	Rabin Medical Center	Petah-Tikva	HaMerkaz
Israel	Clalit Health Services - Sakhnin Community Clinic	Sakhnin	HaTsafon
Mexico	Centro de Estudios de Investigacion Metabolicos y Cardiovasculares	Ciudad Madero	Tamaulipas
Mexico	Cryptex Investigación Clínica S.A. de C.V.	Cuauhtémoc	Distrito Federal
Mexico	Virgen Cardiovascular Research SC	Guadalajara	Jalisco
Mexico	Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares	Mexico City	Distrito Federal
Mexico	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo León
Mexico	Centro de Investigacion Cardiovascular y Metabólica	Tijuana	Baja California
Turkey	Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi	Adana
Turkey	Akdeniz Universitesi Hastanesi	Antalya
Turkey	Uludag Universitesi	Bursa
Turkey	Dicle Üniversitesi	Diyarbakir
Turkey	Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi	Gaziantep
Turkey	Acibadem Universitesi Atakent Hastanesi	Istanbul
Turkey	Marmara Universitesi Pendik Egitim Arastirma Hastanesi	Istanbul
Turkey	Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi	Istanbul
Turkey	TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi	Kadikoy	Istanbul
Turkey	Ondokuz Mayis Universitesi	Samsun
United Kingdom	Layton Medical Centre	Blackpool	Lancashire
United Kingdom	Cheadle Community Hospital	Cheadle	Staffordshire
United Kingdom	Rowden Surgery	Chippenham	England
United Kingdom	Hammersmith and Fulham Partnership Research Unit	London	Hammersmith And Fulham
United Kingdom	St Clare Medical Centre	Penzance	Cornwall
United Kingdom	Abbeywell Surgery	Romsey	England
United Kingdom	Windrush Medical Practice	Witney	Oxfordshire
United States	Care Access - Aurora	Aurora	Colorado
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	Velocity Clinical Research, Mt. Auburn	Cincinnati	Ohio
United States	John Muir Physician Network Research Center	Concord	California
United States	Qualmedica Research, LLC	Evansville	Indiana
United States	Juno Research	Houston	Texas
United States	Southern Endocrinology Associates	Mesquite	Texas
United States	Retreat Medical Research	Miami	Florida
United States	Clinical Research Associates Inc	Nashville	Tennessee
United States	Alta Pharmaceutical Research Center	Peachtree Corners	Georgia
United States	American Research Centers of Florida	Pembroke Pines	Florida
United States	Summit Headlands	Portland	Oregon
United States	Care Access - Sacramento	Sacramento	California
United States	AGILE Clinical Research Trials, LLC	Sandy Springs	Georgia
United States	WellNow Urgent Care and Research - Schenectady	Schenectady	New York
United States	Medical Advancement Centers of Arizona	Tempe	Arizona
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	Integrated Clinical Trial Services, Inc.	West Des Moines	Iowa
United States	Accellacare - Wilmington - 1917 Tradd Court	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Israel,  Mexico,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Body Weight		Baseline (Week 0), Week 44
Secondary	Change from Baseline in HbA1c		Baseline (Week 0), Week 44
Secondary	Change from Baseline in HbA1c		Baseline (Week 24), Week 80
Secondary	Percent Change from Baseline in Body Weight		Baseline (Week 24), Week 80
Secondary	Absolute Change from Baseline in Body Weight		Baseline (Week 0), Week 44
Secondary	Absolute Change from Baseline in Body Weight		Baseline (Week 24), Week 80
Secondary	Change from Baseline in Body Mass Index (BMI)		Baseline (Week 0), Week 44
Secondary	Change from Baseline in BMI		Baseline (Week 24), Week 80
Secondary	Change from Baseline in Waist Circumference		Baseline (Week 0), Week 44
Secondary	Change from Baseline in Waist Circumference		Baseline (Week 24), Week 80
Secondary	Percentage of Participants Achieving =15% Body Weight Reduction		Baseline (Week 0), Week 44
Secondary	Percentage of Participants Achieving =15% Body Weight Reduction		Baseline (Week 0), Week 80
Secondary	Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)	Steady State Area Under the Concentration Time Curve (AUC) presented as a single average measure of AUC across the time frame.	Baseline through Week 44

External Links

•   A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity