Clinical trial NCT04881760: A Study of LY3437943 in Participants Who Have Obesity or Are Overweight
Official title: A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Overweight
Keywords: Nutritional or Metabolism Disorder
Weight Loss
Overnutrition
Incretins
Hormones
Physiological Effects of Drugs
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-05-11
Enrollment: 338
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: This is a study of LY3437943 in participants who have obesity or are overweight. The main purpose is to learn more about how LY3437943 affects body weight loss. The study will last about 18 months and may include up to 18 visits.


Eligibility criteria: Inclusion Criteria:

* Participants must have a Body Mass Index (BMI) ) ≥30 and ≤50 kilograms per square meter (kg/m²), or ≥27 kg/m² and \<30 kg/m², with at least one of the following comorbidities: hypertension, dyslipidemia, cardiovascular disease
* Participants must be willing to learn how to self-inject study drug or receive an injection from a trained individual if visually impaired or with physical limitations, and follow study procedures for the duration of the study, including, but not limited to, follow lifestyle advice (for example, dietary changes and physical activity plan), maintain a study drug administration log, and complete required questionnaires

Exclusion Criteria:

* Participants must not have type 1 or type 2 diabetes mellitus
* Participants must not have had an increase or decrease in body weight \> more than 5 kg (11 pounds) within the past 3 months
* Participants must not have had surgery for obesity or plan to have such surgery during the study
* Participants must not be using medications that promote weight loss or cause weight gain
* Participants must not drink excessive amounts of alcohol (more than 14 units a week for women or more than 21 units a week for men)
* Participants must not have used marijuana within the last 3 months.
* Participants must not have heart attack, stroke, or hospitalization for congestive heart failure in the past 3 months
* Participants must not have active cancer within the last 5 years
* Participants must not have uncontrolled high blood pressure
* Participants must not have liver disease other than non-alcoholic fatty liver disease
* Participants must not have renal impairment with estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m2
* Participants must not have a history of acute or chronic pancreatitis symptomatic gallbladder disease or documented human immunodeficiency virus infection
* Participants must not have a major problem with depression or other mental illness within the last 2 years
* Participants must not have family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (family is defined as a first degree relative)
* Female participants must not be pregnant, breast-feeding, or intend to become pregnant or of childbearing potential and not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)

Primary outcomes:
measure: Mean Percent Change From Baseline in Body Weight
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Mean Percent Change From Baseline in Body Weight
timeFrame: Baseline, Week 48
measure: Percentage of Participants Who Achieve ≥ 5% Body Weight Reduction
timeFrame: Week 24
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 24
measure: Percentage of Participants Who Achieve ≥ 10% Body Weight Reduction
timeFrame: Week 48
measure: Percentage of Participants Who Achieve ≥ 15% Body Weight Reduction
timeFrame: Week 24
measure: Percentage of Participants Who Achieve ≥ 15% Body Weight Reduction
timeFrame: Week 48
measure: Mean Change From Baseline in Body Weight
timeFrame: Baseline, Week 24
measure: Mean Change From Baseline in Body Weight
timeFrame: Baseline, Week 48
measure: Mean Change From Baseline in BMI
timeFrame: Baseline, Week 24
measure: Mean Change From Baseline in BMI
timeFrame: Baseline, Week 48
measure: Mean Change From Baseline in Waist Circumference
timeFrame: Baseline, Week 24
measure: Mean Change From Baseline in Waist Circumference
timeFrame: Baseline, Week 48
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Perseverance Research Center
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Huntington Park
country: United States
facility: Velocity Clinical Research, Huntington Park
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Research, Huntington Park
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology, Inc.
state: California
city: Ventura
country: United States
facility: Coastal Metabolic Research Centre
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Weston
country: United States
facility: Encore Medical Research - Weston
state: Florida
city: Springfield
country: United States
facility: Springfield Diabetes & Endocrine Center
state: Illinois
city: Topeka
country: United States
facility: Cotton O'Neil Diabetes and Endocrinology Center
state: Kansas
city: Marrero
country: United States
facility: Tandem Clinical Research,LLC
state: Louisiana
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Raritan
country: United States
facility: Amici Clinical Research LLC
state: New Jersey
city: Norman
country: United States
facility: Intend Research, LLC
state: Oklahoma
city: Pittsburgh
country: United States
facility: Allegheny Endocrinology Associates
state: Pennsylvania
city: Knoxville
country: United States
facility: New Phase Research and Development
state: Tennessee
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: Houston
country: United States
facility: Juno Research
state: Texas
city: Houston
country: United States
facility: Endocrine Ips, Pllc
state: Texas
city: Mesquite
country: United States
facility: Southern Endocrinology Associates
state: Texas
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Guaynabo
country: Puerto Rico
facility: Private Practice - Dr. Paola Mansilla-Letelier
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC - Hato Rey Site
city: San Juan
country: Puerto Rico
facility: San Juan City Hospital
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: