A Study of LY3437943 in Participants Who Have Obesity or Are Overweight

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04881760

Collaborator

(none)

494

Enrollment

Locations

Arms

18.3

Anticipated Duration (Months)

17.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Overweight	Drug: LY3437943 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

494 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 20, 2021

Anticipated Primary Completion Date :

May 16, 2022

Anticipated Study Completion Date :

Nov 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3437943 Dose 1 LY3437943 administered subcutaneously (SC)	Drug: LY3437943 Administered SC
Experimental: LY3437943 Dose 2 LY3437943 administered SC	Drug: LY3437943 Administered SC
Experimental: LY3437943 Dose 3 LY3437943 administered SC	Drug: LY3437943 Administered SC
Experimental: LY3437943 Dose 4 LY3437943 administered SC	Drug: LY3437943 Administered SC
Placebo Comparator: Placebo Placebo administered SC	Drug: Placebo Administered SC

Outcome Measures

Primary Outcome Measures

Mean Percent Change in Body Weight [Randomization, Week 24]

Secondary Outcome Measures

Mean Percent Change in Body Weight [Randomization, Week 48]
Percentage of Participants Who Achieve ≥5% Body Weight Reduction [Week 24]
Percentage of Participants Who Achieve ≥5% Body Weight Reduction [Week 48]
Percentage of Participants Who Achieve ≥10% Body Weight Reduction [Week 24]
Percentage of Participants Who Achieve ≥10% Body Weight Reduction [Week 48]
Percentage of Participants Who Achieve ≥15% Body Weight Reduction [Week 24]
Percentage of Participants Who Achieve ≥15% Body Weight Reduction [Week 48]
Mean Change from Randomization in Body Weight [Randomization, Week 24]
Mean Change from Randomization in Body Weight [Randomization, Week 48]
Mean Change from Randomization in Body Mass Index (BMI) [Randomization, Week 24]
Mean Change from Randomization in BMI [Randomization, Week 48]
Mean Change from Randomization in Waist Circumference [Randomization, Week 24]
Mean Change from Randomization in Waist Circumference [Randomization, Week 48]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Perseverance Research Center	Scottsdale	Arizona	United States	85254
2	Anaheim Clinical Trials, LLC	Anaheim	California	United States	92801
3	Valley Research	Fresno	California	United States	93720
4	Velocity Clinical Research, Huntington Park	Huntington Park	California	United States	90255
5	Velocity Clinical Research, Huntington Park	Los Angeles	California	United States	90057
6	Southern California Dermatology, Inc.	Santa Ana	California	United States	92701
7	Coastal Metabolic Research Centre	Ventura	California	United States	93003
8	Diablo Clinical Research, Inc.	Walnut Creek	California	United States	94598
9	East Coast Institute for Research, LLC	Jacksonville	Florida	United States	32216
10	Suncoast Clinical Research, Inc.	New Port Richey	Florida	United States	34652
11	Encore Medical Research - Weston	Weston	Florida	United States	33331
12	Springfield Diabetes & Endocrine Center	Springfield	Illinois	United States	62711
13	Cotton O'Neil Diabetes and Endocrinology Center	Topeka	Kansas	United States	66606
14	Tandem Clinical Research,LLC	Marrero	Louisiana	United States	70072
15	StudyMetrix Research	Saint Peters	Missouri	United States	63303
16	Amici Clinical Research LLC	Raritan	New Jersey	United States	08869
17	Intend Research, LLC	Norman	Oklahoma	United States	73069
18	Allegheny Endocrinology Associates	Pittsburgh	Pennsylvania	United States	15212
19	New Phase Research and Development	Knoxville	Tennessee	United States	37909
20	Texas Diabetes & Endocrinology, P.A.	Austin	Texas	United States	78731
21	Dallas Diabetes Research Center	Dallas	Texas	United States	75230
22	Juno Research	Houston	Texas	United States	77054
23	Endocrine Ips, Pllc	Houston	Texas	United States	77079
24	Southern Endocrinology Associates	Mesquite	Texas	United States	75149
25	Rainier Clinical Research Center	Renton	Washington	United States	98057
26	Private Practice - Dr. Paola Mansilla-Letelier	Guaynabo		Puerto Rico	00970
27	GCM Medical Group, PSC - Hato Rey Site	San Juan		Puerto Rico	00917
28	San Juan City Hospital	San Juan		Puerto Rico	00935

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: 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), Eli Lilly and Company