Clinical trial NCT06037252: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Type 2 Diabetes
Obesity
Keywords: Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Disease
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Body Weight
Tirzepatide
Incretins
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-09-14
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percent Change From Baseline in Body Weight
timeFrame: Baseline (Week 0), Week 44
Secondary outcomes:
measure: Change from Baseline in HbA1c
timeFrame: Baseline (Week 0), Week 44
measure: Change from Baseline in HbA1c
timeFrame: Baseline (Week 24), Week 80
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline (Week 24), Week 80
measure: Absolute Change from Baseline in Body Weight
timeFrame: Baseline (Week 0), Week 44
measure: Absolute Change from Baseline in Body Weight
timeFrame: Baseline (Week 24), Week 80
measure: Change from Baseline in Body Mass Index (BMI)
timeFrame: Baseline (Week 0), Week 44
measure: Change from Baseline in BMI
timeFrame: Baseline (Week 24), Week 80
measure: Change from Baseline in Waist Circumference
timeFrame: Baseline (Week 0), Week 44
measure: Change from Baseline in Waist Circumference
timeFrame: Baseline (Week 24), Week 80
measure: Percentage of Participants Achieving ≥15% Body Weight Reduction
timeFrame: Baseline (Week 0), Week 44
measure: Percentage of Participants Achieving ≥15% Body Weight Reduction
timeFrame: Baseline (Week 0), Week 80
measure: Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)
timeFrame: Baseline through Week 44
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medical Advancement Centers of Arizona
state: Arizona
city: Concord
country: United States
facility: John Muir Physician Network Research Center
state: California
city: Sacramento
country: United States
facility: Care Access - Sacramento
state: California
city: Aurora
country: United States
facility: Care Access - Aurora
state: Colorado
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Miami
country: United States
facility: Retreat Medical Research
state: Florida
city: Pembroke Pines
country: United States
facility: American Research Centers of Florida
state: Florida
city: Norcross
country: United States
facility: Alta Pharmaceutical Research Center
state: Georgia
city: Sandy Springs
country: United States
facility: AGILE Clinical Research Trials, LLC
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Evansville
country: United States
facility: Qualmedica Research, LLC
state: Indiana
city: West Des Moines
country: United States
facility: Integrated Clinical Trial Services, Inc.
state: Iowa
city: Wilmington
country: United States
facility: Accellacare - Wilmington - 1917 Tradd Court
state: North Carolina
city: Cincinnati
country: United States
facility: Velocity Clinical Research, Mt. Auburn
state: Ohio
city: Portland
country: United States
facility: Summit Headlands
state: Oregon
city: Nashville
country: United States
facility: Clinical Research Associates Inc
state: Tennessee
city: Houston
country: United States
facility: Juno Research
state: Texas
city: Mesquite
country: United States
facility: Southern Endocrinology Associates
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Caba
country: Argentina
facility: CEDIC
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Consultorio de Investigación Clínica EMO SRL
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro Médico Viamonte
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
city: Tijuana
country: Mexico
facility: Centro de Investigacion Cardiovascular y Metabólica
state: Baja California
city: Cuauhtémoc, Ciudad De México
country: Mexico
facility: Cryptex Investigación Clínica S.A. de C.V.
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Virgen Cardiovascular Research SC
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo León
city: Ciudad Madero
country: Mexico
facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
state: Tamaulipas
city: Kadikoy
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
state: İstanbul
city: Adana
country: Turkey
facility: Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi
city: Antalya
country: Turkey
facility: Akdeniz Universitesi Hastanesi
city: Bursa
country: Turkey
facility: Uludag Universitesi
city: Diyarbakir
country: Turkey
facility: Dicle Üniversitesi
city: Gaziantep
country: Turkey
facility: Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
city: Istanbul
country: Turkey
facility: Acibadem Universitesi Atakent Hastanesi
city: Istanbul
country: Turkey
facility: Marmara Universitesi Pendik Egitim Arastirma Hastanesi
city: Samsun
country: Turkey
facility: Ondokuz Mayıs Universitesi
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: