Clinical trial NCT04657003: A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight
Official title: Efficacy and Safety of Tirzepatide Once Weekly in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Overweight
Obesity
Keywords: Metabolism and Nutrition Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-12-07
Enrollment: 938
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study of tirzepatide in participants with type 2 diabetes who have obesity or are overweight. The main purpose is to learn more about how tirzepatide affects body weight. The study will last 79 weeks (22 visits).


Eligibility criteria: Inclusion Criteria:

* Have Type 2 Diabetes (T2DM) with HbA1c ≥7% to ≤10% at screening, on stable therapy for the last 3 months prior to screening. T2DM may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or glucagon like peptide-1 receptor agonists (GLP-1 RAs)
* Have a BMI of ≥27 kg/m²
* Are overweight or have obesity
* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight
* Are at least 18 years of age and age of majority per local laws and regulations

Exclusion Criteria:

* Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except T2DM
* Have at least 2 confirmed fasting self-monitoring blood glucose (SMBG) values \>270 mg/dL(on 2 nonconsecutive days) prior to Visit 3
* Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment
* Have self-reported change in body weight \>5kg within 3 months prior to screening
* Have had a history of chronic or acute pancreatitis
* Change in body weight greater than 5 kg within 3 months prior to starting study
* Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
* Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
* History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
* Any lifetime history of a suicide attempt

Primary outcomes:
measure: Percent Change From Baseline in Body Weight
timeFrame: Baseline, Week 72
measure: Percentage of Participants Who Achieve ≥5% Body Weight Reduction From Baseline
timeFrame: Week 72
Secondary outcomes:
measure: Percentage of Participants Who Achieve ≥10% Body Weight Reduction From Baseline
timeFrame: Week 72
measure: Percentage of Participants Who Achieve ≥15% Body Weight Reduction From Baseline
timeFrame: Week 72
measure: Percentage of Participants Who Achieve ≥20% Body Weight Reduction From Baseline
timeFrame: Week 72
measure: Change From Baseline in Absolute Body Weight
timeFrame: Baseline, Week 72
measure: Change From Baseline in Body Mass Index (BMI)
timeFrame: Baseline, Week 72
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 72
measure: Percentage of Participants Who Achieve HbA1c <7%
timeFrame: Week 72
measure: Percentage of Participants Who Achieve HbA1c ≤6.5%
timeFrame: Week 72
measure: Percentage of Participants Who Achieve HbA1c <5.7%
timeFrame: Week 72
measure: Change From Baseline in Fasting Glucose
timeFrame: Baseline, Week 72
measure: Change From Baseline in Waist Circumference
timeFrame: Baseline, Week 72
measure: Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
timeFrame: Baseline, Week 72
measure: Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
timeFrame: Baseline, Week 72
measure: Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
timeFrame: Baseline, Week 72
measure: Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
timeFrame: Baseline, Week 72
measure: Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg)
timeFrame: Baseline, Week 72
measure: Percent Change From Baseline in Non-High Density Lipoprotein (Non-HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
timeFrame: Baseline, Week 72
measure: Percent Change From Baseline in Free Fatty Acids (Pooled Doses of 10 mg and 15 mg Tirzepatide)
timeFrame: Baseline, Week 72
measure: Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide)
timeFrame: Baseline, Week 72
measure: Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide)
timeFrame: Baseline, Week 72
measure: Percent Change From Baseline in Fasting Insulin
timeFrame: Baseline, Week 72
measure: Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
timeFrame: Baseline, Week 72
measure: Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL Lite-CT) Physical Function Composite Score
timeFrame: Baseline, Week 72
measure: Population Pharmacokinetics (PopPK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide
timeFrame: Week 8, 16, 36: 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama - Department of Nutrition Sciences
state: Alabama
city: Little Rock
country: United States
facility: KLR Business Group, Inc. dba Arkansas Clinical Research
state: Arkansas
city: Huntington Park
country: United States
facility: Velocity Clinical Research, Huntington Park
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Research, Westlake
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Tustin
country: United States
facility: University Clinical Investigators, Inc.
state: California
city: Cooper City
country: United States
facility: ALL Medical Research, LLC
state: Florida
city: Fleming Island
country: United States
facility: Northeast Research Institute (NERI)
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Ocoee
country: United States
facility: West Orange Endocrinology
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute, Inc.
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine- Grady Campus
state: Georgia
city: Macon
country: United States
facility: East Coast Institute for Research, LLC
state: Georgia
city: Honolulu
country: United States
facility: Pacific Diabetes & Endocrine Center
state: Hawaii
city: Blackfoot
country: United States
facility: Elite Clinical Trials
state: Idaho
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: Greenfield
country: United States
facility: American Health Network of Indiana, LLC - Greenfield
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center
state: Kansas
city: Baltimore
country: United States
facility: Maryland Cardiovascular Specialists
state: Maryland
city: Oxon Hill
country: United States
facility: MD Medical Research
state: Maryland
city: Fall River
country: United States
facility: NECCR PrimaCare Research
state: Massachusetts
city: Troy
country: United States
facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
state: Michigan
city: Kalispell
country: United States
facility: Logan Health Research
state: Montana
city: Trenton
country: United States
facility: Premier Research
state: New Jersey
city: Chapel Hill
country: United States
facility: University of North Carolina Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center (WFUBMC)
state: North Carolina
city: Cleveland
country: United States
facility: Velocity Clinical Research, Cleveland
state: Ohio
city: Dublin
country: United States
facility: Aventiv Research
state: Ohio
city: Corvallis
country: United States
facility: The Corvallis Clinic, P.C.
state: Oregon
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Warwick
country: United States
facility: Center for Neurosciences
state: Rhode Island
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC
state: South Carolina
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes Research Center
state: Texas
city: Fort Worth
country: United States
facility: Diabetes and Thyroid Center of Fort Worth
state: Texas
city: Houston
country: United States
facility: Juno Research
state: Texas
city: Houston
country: United States
facility: Endocrine Ips, Pllc
state: Texas
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc.
state: Virginia
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Kenosha
country: United States
facility: Clinical Investigation Specialists
state: Wisconsin
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Consultorio de Investigación Clínica EMO SRL
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clínicas Mar del Plata
state: Buenos Aires
city: San Nicolas
country: Argentina
facility: Go Centro Medico San Nicolás
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro Médico Viamonte
state: Ciudad Autónoma De Buenos Aire
city: Caba
country: Argentina
facility: CIPREC
state: Ciudad Autónoma De Buenos Aire
city: SAN M. DE Tucuman
country: Argentina
facility: Centro de Investigaciones Médicas Tucuman
state: Tucumán
city: Santiago del Estero
country: Argentina
facility: Sanatorio Norte
city: Fortaleza
country: Brazil
facility: Private Practice - Dr.Miguel N. Hissa
state: Ceará
city: Campinas
country: Brazil
facility: Loema Instituto de Pesquisa Clinica
state: São Paulo
city: Campinas
country: Brazil
facility: Instituto de Pesquisa clinica de Campinas
state: São Paulo
city: Jaú
country: Brazil
facility: CECIP - Centro de Estudos do Interior Paulista
state: São Paulo
city: Sao Paulo
country: Brazil
facility: CPCLIN
state: São Paulo
city: São Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigação Clínica
city: Bangalore
country: India
facility: Life Care Hospital and Research Centre
state: Karnataka
city: Kolkata
country: India
facility: ILS Hospitals
state: West Bengal
city: Yamato-shi
country: Japan
facility: Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
state: Kanagawa
city: Suita-shi
country: Japan
facility: Medical Corporation Heishinkai OCROM Clinic
state: Osaka
city: Ootaku
country: Japan
facility: Medical Corporation Sato Medical clinic
state: Tokyo
city: Osaka
country: Japan
facility: AMC Nishiumeda Clinic
city: Caguas
country: Puerto Rico
facility: Centro de Endocrinologia y Nutricion
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC - Hato Rey Site
city: Moscow
country: Russian Federation
facility: Endocrinology Research Center of Rosmedtechnologies
state: Moskva
city: Moscow
country: Russian Federation
facility: Russian Medical Academy of Postgraduate Education
state: Moskva
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg City Hospital of Saint Elizabeth
state: Sankt-Pete
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical University
city: Changhua County
country: Taiwan
facility: Changhua Christian Hospital
state: Changhua
city: Tainan City
country: Taiwan
facility: Chi Mei Medical Center
state: Tainan
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng-Kung Uni. Hosp.
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: