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

Primary Purpose

Type 2 Diabetes, Obesity

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tirzepatide
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases, Overnutrition, Nutrition Disorders, Body Weight, Tirzepatide, Incretins

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • CEDICRecruiting
  • Centro de Investigaciones Metabólicas (CINME)Recruiting
  • Centro Médico ViamonteRecruiting
  • Consultorio de Investigación Clínica EMO SRLRecruiting
  • Centro Medico Dra. Laura Maffei- Investigacion Clinica AplicadaRecruiting
  • Praktik Velim s.r.o
  • MUDr. Tomas EdelsbergerRecruiting
  • Milan Kvapil s.r.o., Diabetologicka ambulanceRecruiting
  • ResTrial s.r.o.Recruiting
  • FLEDIP s.r.o.
  • Diacentrum Brandys n.L. s.r.o.Recruiting
  • MUDr. Vladimira Fleischmannova, s.r.o.
  • Diahaza s.r.o.Recruiting
  • Klinika Dr. Pirka
  • Praglandia s.r.o
  • Centro de Investigacion Cardiovascular y MetabólicaRecruiting
  • Cryptex Investigación Clínica S.A. de C.V.Recruiting
  • Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades CardiovascularesRecruiting
  • Virgen Cardiovascular Research SCRecruiting
  • Centro de Estudios de Investigacion Metabolicos y CardiovascularesRecruiting
  • IN-DIARecruiting
  • Fakultná nemocnica Nitra
  • FunkystuffRecruiting
  • DiabetolRecruiting
  • ENDIAMED s.r.oRecruiting
  • NEDÚ - Národný endokrinologický a diabetologický ústav n.o.Recruiting
  • IRIDIARecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Tirzepatide High Dose 1

Tirzepatide High Dose 2

Tirzepatide

Placebo

Arm Description

Participants will receive tirzepatide subcutaneously (SC).

Participants will receive tirzepatide SC.

Participants will receive tirzepatide SC.

Participants will receive placebo.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Body Weight

Secondary Outcome Measures

Change from Baseline in HbA1c
Change from Baseline in HbA1c
Percent Change from Baseline in Body Weight
Absolute Change from Baseline in Body Weight
Absolute Change from Baseline in Body Weight
Change from Baseline in Body Mass Index (BMI)
Change from Baseline in BMI
Change from Baseline in Waist Circumference
Change from Baseline in Waist Circumference
Percentage of Participants Achieving ≥15% Body Weight Reduction
Percentage of Participants Achieving ≥15% Body Weight Reduction
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.

Full Information

First Posted
September 8, 2023
Last Updated
October 17, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT06037252
Brief Title
A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 1, 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2023 (Actual)
Primary Completion Date
December 24, 2024 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Obesity
Keywords
Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases, Overnutrition, Nutrition Disorders, Body Weight, Tirzepatide, Incretins

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tirzepatide High Dose 1
Arm Type
Experimental
Arm Description
Participants will receive tirzepatide subcutaneously (SC).
Arm Title
Tirzepatide High Dose 2
Arm Type
Experimental
Arm Description
Participants will receive tirzepatide SC.
Arm Title
Tirzepatide
Arm Type
Active Comparator
Arm Description
Participants will receive tirzepatide SC.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo.
Intervention Type
Drug
Intervention Name(s)
Tirzepatide
Other Intervention Name(s)
LY3298176
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Body Weight
Time Frame
Baseline (Week 0), Week 44
Secondary Outcome Measure Information:
Title
Change from Baseline in HbA1c
Time Frame
Baseline (Week 0), Week 44
Title
Change from Baseline in HbA1c
Time Frame
Baseline (Week 24), Week 80
Title
Percent Change from Baseline in Body Weight
Time Frame
Baseline (Week 24), Week 80
Title
Absolute Change from Baseline in Body Weight
Time Frame
Baseline (Week 0), Week 44
Title
Absolute Change from Baseline in Body Weight
Time Frame
Baseline (Week 24), Week 80
Title
Change from Baseline in Body Mass Index (BMI)
Time Frame
Baseline (Week 0), Week 44
Title
Change from Baseline in BMI
Time Frame
Baseline (Week 24), Week 80
Title
Change from Baseline in Waist Circumference
Time Frame
Baseline (Week 0), Week 44
Title
Change from Baseline in Waist Circumference
Time Frame
Baseline (Week 24), Week 80
Title
Percentage of Participants Achieving ≥15% Body Weight Reduction
Time Frame
Baseline (Week 0), Week 44
Title
Percentage of Participants Achieving ≥15% Body Weight Reduction
Time Frame
Baseline (Week 0), Week 80
Title
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)
Description
Steady State Area Under the Concentration Time Curve (AUC) presented as a single average measure of AUC across the time frame.
Time Frame
Baseline through Week 44

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
CEDIC
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1060ABN
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
541148236838
First Name & Middle Initial & Last Name & Degree
Elizabeth Gelersztein
Facility Name
Centro de Investigaciones Metabólicas (CINME)
City
Ciudad Autónoma de Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
1056
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
00541139842826
First Name & Middle Initial & Last Name & Degree
Federico C. Perez Manghi
Facility Name
Centro Médico Viamonte
City
Buenos Aires
State/Province
Ciudad Aut
ZIP/Postal Code
C1120AAC
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
541149635650
First Name & Middle Initial & Last Name & Degree
Diego Aizenberg
Facility Name
Consultorio de Investigación Clínica EMO SRL
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciudad Autónoma De Buenos Aire
ZIP/Postal Code
1405
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
5491157417654
First Name & Middle Initial & Last Name & Degree
Pablo Rene Costanzo
Facility Name
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciudad Autónoma De Buenos Aire
ZIP/Postal Code
C1425AGC
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
541148019001
First Name & Middle Initial & Last Name & Degree
Maria Jimena Coronel
Facility Name
Praktik Velim s.r.o
City
Velim
State/Province
Kolín
ZIP/Postal Code
281 01
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josef Slaby
Facility Name
MUDr. Tomas Edelsberger
City
Krnov
State/Province
Moravskosl
ZIP/Postal Code
79401
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
Phone
420606703809
First Name & Middle Initial & Last Name & Degree
Tomas Edelsberger
Facility Name
Milan Kvapil s.r.o., Diabetologicka ambulance
City
Praha
State/Province
Praha 4
ZIP/Postal Code
14900
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
Phone
420272917011
First Name & Middle Initial & Last Name & Degree
Dagmar Bartaskova
Facility Name
ResTrial s.r.o.
City
Praha
State/Province
Praha 8
ZIP/Postal Code
18100
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
Phone
420257211886
First Name & Middle Initial & Last Name & Degree
Emilia Malicherova
Facility Name
FLEDIP s.r.o.
City
Prague
State/Province
Praha, Hlavní Mešto
ZIP/Postal Code
160 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
420736204140
First Name & Middle Initial & Last Name & Degree
Milan Flekac
Facility Name
Diacentrum Brandys n.L. s.r.o.
City
Brandys nad Labem
State/Province
Praha-vých
ZIP/Postal Code
25001
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarka Kopecka
Facility Name
MUDr. Vladimira Fleischmannova, s.r.o.
City
Kolín
State/Province
Středočeský Kraj
ZIP/Postal Code
280 02
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
420321752571
First Name & Middle Initial & Last Name & Degree
Vladimira Fleischmannova
Facility Name
Diahaza s.r.o.
City
Holesov
State/Province
Zlínský Kraj
ZIP/Postal Code
769 01
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
Phone
420573399559
First Name & Middle Initial & Last Name & Degree
Jitka Hasalova Zapletalova
Facility Name
Klinika Dr. Pirka
City
Mladá Boleslav
ZIP/Postal Code
293 01
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
420326375404
First Name & Middle Initial & Last Name & Degree
Martina Koskova
Facility Name
Praglandia s.r.o
City
Praha 5
ZIP/Postal Code
150 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
420731586736
First Name & Middle Initial & Last Name & Degree
Vera Klokocnikova
Facility Name
Centro de Investigacion Cardiovascular y Metabólica
City
Tijuana
State/Province
Baja California
ZIP/Postal Code
22500
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Fajardo Campos
Facility Name
Cryptex Investigación Clínica S.A. de C.V.
City
Cuauhtémoc, Ciudad De México
State/Province
Distrito Federal
ZIP/Postal Code
06100
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MIGUEL ANGEL GOMEZ-SAMANO
Facility Name
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
11650
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
525585340943
First Name & Middle Initial & Last Name & Degree
Melchor Alpizar
Facility Name
Virgen Cardiovascular Research SC
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
3338131040
First Name & Middle Initial & Last Name & Degree
Luis Ramon Virgen Carrillo
Facility Name
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
City
Ciudad Madero
State/Province
Tamaulipas
ZIP/Postal Code
89440
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
52183312600
First Name & Middle Initial & Last Name & Degree
Rafael Margarito Violante Ortiz
Facility Name
IN-DIA
City
Lučenec
State/Province
Banskobystrický Kraj
ZIP/Postal Code
984 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
Phone
00421905503919
First Name & Middle Initial & Last Name & Degree
Livia Tomasova
Facility Name
Fakultná nemocnica Nitra
City
Nitra
State/Province
Nitriansky Kraj
ZIP/Postal Code
950 01
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
421907705249
First Name & Middle Initial & Last Name & Degree
Peter Minarik
Facility Name
Funkystuff
City
Nove Zamky
State/Province
Nitriansky Kraj
ZIP/Postal Code
940 02
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
Phone
421356420746
First Name & Middle Initial & Last Name & Degree
Miriam Teplanova
Facility Name
Diabetol
City
Prešov
State/Province
Prešovský Kraj
ZIP/Postal Code
080 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
Phone
0903625849
First Name & Middle Initial & Last Name & Degree
Marek Macko
Facility Name
ENDIAMED s.r.o
City
Dolny Kubin
State/Province
Žilinský Kraj
ZIP/Postal Code
026 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
Phone
421433709580
First Name & Middle Initial & Last Name & Degree
Jan Truban
Facility Name
NEDÚ - Národný endokrinologický a diabetologický ústav n.o.
City
Lubochna
State/Province
Žilinský Kraj
ZIP/Postal Code
034 91
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
Phone
0911444616
First Name & Middle Initial & Last Name & Degree
Emil Martinka
Facility Name
IRIDIA
City
Vrutky
State/Province
Žilinský Kraj
ZIP/Postal Code
038 61
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
Phone
421907454191
First Name & Middle Initial & Last Name & Degree
Radovan Plasil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
ata are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/
Links:
URL
https://trials.lilly.com/en-US/trial/422915
Description
A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity

Learn more about this trial

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

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