Clinical trial NCT06603571: A Study to Investigate Weight Management With LY3841136 and Tirzepatide (LY3298176), Alone or in Combination, in Adult Participants With Obesity or Overweight With Type 2 Diabetes
Official title: A Phase 2, Parallel-Group, Double-Blind, Placebo-Controlled Study to Investigate Weight Management With LY3841136 and Tirzepatide, Alone or in Combination, in Adult Participants With Obesity or Overweight With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Obesity
Overweight
Keywords: Type 2 Diabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-09-19
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, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to investigate the safety and efficacy of LY3841136 for chronic weight management alone or in combination with Tirzepatide across a wide dose range in participants with Type 2 Diabetes. Participation in the study will last about 64 weeks.


Eligibility criteria: Inclusion Criteria:

W8M-MC-LAA2

* Have a Body Mass Index (BMI) of ≥27 kilograms per square meter (kg/m²)
* Have Type 2 Diabetes
* Have a HbA1c ≥7.0 % (53 millimoles/mole (mmol/mol)) to ≤10.5% (91 mmol/mol) and treated with diet and exercise alone or with a stable dose of metformin (and not more than the locally approved dose) with or without a sodium-glucose cotransporter 2 (SGLT2) inhibitor for at least 3 months prior to screening

W8M-MC-CWMM:

* Have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss)

Exclusion Criteria:

W8M-MC-LAA2

* Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening
* Have an on-going or history of bradyarrhythmia and/or sinus bradycardia
* Have an elevated resting pulse rate (mean \>100 beats per minute (bpm)) or reduced resting pulse rate (mean \<60 bpm) at screening
* Have any of the following cardiovascular conditions within 6 months prior to screening:

  * acute myocardial infarction
  * cerebrovascular accident (stroke)
  * unstable angina, or
  * hospitalization due to congestive heart failure
* Have renal impairment measured as estimated glomerular filtration rate (eGFR) \<45 milliliters per minute (mL/min)/1.73 m2
* Have a history of acute or chronic pancreatitis
* Have fasting triglycerides \>500 milligrams per deciliter (mg/dL) (5.7 mmol/L) at screening
* All concomitant medications should be at a stable dose for at least 3 months prior to screening

W8M-MC-CWMM

* Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \>1 year prior to screening.
* Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma.
* Have poorly controlled hypertension.
* Have a history of symptomatic gallbladder disease within the past 2 years
* Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
* Have a lifetime history of suicide attempts.

Primary outcomes:
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline, Week 48
Secondary outcomes:
measure: Change from Baseline in Body Weight
timeFrame: Baseline, Week 48
measure: Percentage of Participants Who Achieve ≥5% Body Weight Reduction
timeFrame: Week 48
measure: Percentage of Participants Who Achieve ≥10% Body Weight Reduction
timeFrame: Week 48
measure: Change from baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 48
measure: Pharmacokinetics (PK): Area Under the Curve (AUC) of LY3841136
timeFrame: Baseline, Week 48
measure: PK: Maximum Concentration (Cmax) of LY3841136
timeFrame: Baseline, Week 48
Other outcomes:
Locations:
city: Chandler
country: United States
facility: The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Scottsdale
country: United States
facility: Headlands Research - Scottsdale
state: Arizona
city: Tucson
country: United States
facility: The Institute for Liver Health II dba Arizona Liver Health-Tucson
state: Arizona
city: Greenbrae
country: United States
facility: NorCal Medical Research, Inc
state: California
city: Huntington Park
country: United States
facility: Velocity Clinical Research, Huntington Park
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Fleming Island
country: United States
facility: Northeast Research Institute (NERI)
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Orlando
country: United States
facility: Charter Research - Winter Park
state: Florida
city: The Villages
country: United States
facility: Charter Research - Lady Lake
state: Florida
city: Ammon
country: United States
facility: Medical Research Partners
state: Idaho
city: Chicago
country: United States
facility: Great Lakes Clinical Trials - Andersonville
state: Illinois
city: Chicago
country: United States
facility: Great Lakes Clinical Trials - Ravenswood
state: Illinois
city: Skokie
country: United States
facility: NorthShore University Health System
state: Illinois
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 Diabetes & Endocrinology
state: Kansas
city: Needham
country: United States
facility: Knownwell
state: Massachusetts
city: New Bedford
country: United States
facility: Lucida Clinical Trials
state: Massachusetts
city: Southfield
country: United States
facility: Headlands Research - Detroit
state: Michigan
city: Troy
country: United States
facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
state: Michigan
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Springfield
country: United States
facility: Clinvest Headlands Llc
state: Missouri
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
city: East Syracuse
country: United States
facility: Velocity Clinical Research, Syracuse
state: New York
city: Port Jefferson Station
country: United States
facility: North Suffolk Neurology
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, LLC
state: New York
city: Greensboro
country: United States
facility: Medication Management
state: North Carolina
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research, Inc
state: North Carolina
city: New Bern
country: United States
facility: Lucas Research, Inc.
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC
state: South Carolina
city: Nashville
country: United States
facility: Quality Medical Research
state: Tennessee
city: Austin
country: United States
facility: IMA Clinical Research Austin
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Research, Dallas
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas
state: Texas
city: Houston
country: United States
facility: PlanIt Research, PLLC
state: Texas
city: San Antonio
country: United States
facility: Tekton Research - Fredericksburg Road
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
city: Weslaco
country: United States
facility: Texas Valley Clinical Research
state: Texas
city: Danville
country: United States
facility: Spectrum Medical, Inc.
state: Virginia
city: Wenatchee
country: United States
facility: Central Washington Health Services Association d/b/a Confluence Health
state: Washington
city: Buenos Aires
country: Argentina
facility: Centro Médico Viamonte
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Consultorio de Investigación Clínica EMO SRL
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)
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: