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

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06037252

Collaborator

(none)

350

Enrollment

Locations

Arms

24.3

Anticipated Duration (Months)

7.1

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Obesity	Drug: Tirzepatide Drug: Placebo	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

350 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 21, 2023

Anticipated Primary Completion Date :

Dec 24, 2024

Anticipated Study Completion Date :

Sep 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tirzepatide High Dose 1 Participants will receive tirzepatide subcutaneously (SC).	Drug: Tirzepatide Administered SC Other Names: LY3298176
Experimental: Tirzepatide High Dose 2 Participants will receive tirzepatide SC.	Drug: Tirzepatide Administered SC Other Names: LY3298176
Active Comparator: Tirzepatide Participants will receive tirzepatide SC.	Drug: Tirzepatide Administered SC Other Names: LY3298176
Placebo Comparator: Placebo Participants will receive placebo.	Drug: Placebo Administered SC

Outcome Measures

Primary Outcome Measures

Percent Change From Baseline in Body Weight [Baseline (Week 0), Week 44]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CEDIC	Caba	Buenos Aires	Argentina	C1060ABN
2	CEDIC	Caba	Buenos Aires	Argentina	C1060ABN
3	Consultorio de Investigación Clínica EMO SRL	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	1405
4	Centro de Investigaciones Metabólicas (CINME)	Ciudad Autónoma de Buenos Aires	Buenos Aires	Argentina	1056
5	Centro de Investigaciones Metabólicas (CINME)	Ciudad Autónoma de Buenos Aire	Buenos Aires	Argentina	1056
6	Centro Médico Viamonte	Buenos Aires	Ciudad Aut	Argentina	C1120AAC
7	Centro Médico Viamonte	Buenos Aires	Ciudad Autónoma De Buenos Aires	Argentina	C1120AAC
8	Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada	Ciudad Autonoma de Buenos Aires	Ciudad Autónoma De Buenos Aires	Argentina	C1425AGC
9	Consultorio de Investigación Clínica EMO SRL	Ciudad Autonoma de Buenos Aire	Ciudad Autónoma De Buenos Aire	Argentina	1405
10	Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada	Ciudad Autonoma de Buenos Aire	Ciudad Autónoma De Buenos Aire	Argentina	C1425AGC
11	Praktik Velim s.r.o	Velim	Kolín	Czechia	281 01
12	MUDr. Tomas Edelsberger	Krnov	Moravskoslezský Kraj	Czechia	79401
13	MUDr. Tomas Edelsberger	Krnov	Moravskosl	Czechia	79401
14	Milan Kvapil s.r.o., Diabetologicka ambulance	Praha	Praha 4	Czechia	14900
15	Milan Kvapil s.r.o., Diabetologicka ambulance	Praha	Praha 4	Czechia	14900
16	ResTrial s.r.o.	Praha	Praha 8	Czechia	18100
17	ResTrial s.r.o.	Praha	Praha 8	Czechia	18100
18	FLEDIP s.r.o.	Prague	Praha, Hlavní Mešto	Czechia	160 00
19	FLEDIP s.r.o.	Prague	Praha, Hlavní Mešto	Czechia	160 00
20	Diacentrum Brandys n.L. s.r.o.	Brandys nad Labem	Praha-východ	Czechia	25001
21	Diacentrum Brandys n.L. s.r.o.	Brandys nad Labem	Praha-vých	Czechia	25001
22	MUDr. Vladimira Fleischmannova, s.r.o.	Kolín	Středočeský Kraj	Czechia	280 02
23	MUDr. Vladimira Fleischmannova, s.r.o.	Kolín	Středočeský Kraj	Czechia	280 02
24	Diahaza s.r.o.	Holesov	Zlínský Kraj	Czechia	769 01
25	Diahaza s.r.o.	Holesov	Zlínský Kraj	Czechia	769 01
26	Diabetologie a Podiatrie	Mladá Boleslav		Czechia	293 01
27	Praglandia s.r.o	Praha 5		Czechia	150 00
28	Praglandia s.r.o	Praha 5		Czechia	150 00
29	Centro de Investigacion Cardiovascular y Metabólica	Tijuana	Baja California	Mexico	22500
30	Cryptex Investigación Clínica S.A. de C.V.	Cuauhtémoc	Distrito Federal	Mexico	06100
31	Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares	Mexico City	Distrito Federal	Mexico	11650
32	Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares	Mexico City	Distrito Federal	Mexico	11650
33	Virgen Cardiovascular Research SC	Guadalajara	Jalisco	Mexico	44670
34	Virgen Cardiovascular Research SC	Guadalajara	Jalisco	Mexico	44670
35	Endocrinology	Monterrey	Nuevo León	Mexico	66460
36	Subinvestigation	Ciudad Madero	Tamaulipas	Mexico	89440
37	IN-DIA	Lučenec	Banskobystrický Kraj	Slovakia	984 01
38	IN-DIA	Lučenec	Banskobystrický Kraj	Slovakia	984 01
39	Fakultná nemocnica Nitra	Nitra	Nitriansky Kraj	Slovakia	950 01
40	FUNKYSTUFF s.r.o.	Nove Zamky	Nitriansky Kraj	Slovakia	940 02
41	FUNKYSTUFF s.r.o.	Nove Zamky	Nitriansky Kraj	Slovakia	940 02
42	Diabetol	Prešov	Prešovský Kraj	Slovakia	080 01
43	Diabetol	Prešov	Prešovský Kraj	Slovakia	080 01
44	ENDIAMED s.r.o	Dolny Kubin	Žilinský Kraj	Slovakia	026 01
45	ENDIAMED s.r.o	Dolny Kubin	Žilinský Kraj	Slovakia	026 01
46	NEDÚ - Národný endokrinologický a diabetologický ústav n.o.	Lubochna	Žilinský Kraj	Slovakia	034 91
47	NEDÚ - Národný endokrinologický a diabetologický ústav n.o.	Lubochna	Žilinský Kraj	Slovakia	034 91
48	IRIDIA	Vrutky	Žilinský Kraj	Slovakia	038 61
49	IRIDIA	Vrutky	Žilinský Kraj	Slovakia	038 61

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company