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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04881760
Collaborator
(none)
494
Enrollment
30
Locations
5
Arms
17.2
Anticipated Duration (Months)
16.5
Patients Per Site
1
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 DiseaseIntervention/TreatmentPhase
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 :
Jun 17, 2022
Anticipated Study Completion Date :
Oct 26, 2022

Arms and Interventions

ArmIntervention/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

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

Secondary Outcome Measures

  1. Mean Percent Change in Body Weight [Randomization, Week 48]

  2. Percentage of Participants Who Achieve ≥5% Body Weight Reduction [Week 24]

  3. Percentage of Participants Who Achieve ≥5% Body Weight Reduction [Week 48]

  4. Percentage of Participants Who Achieve ≥10% Body Weight Reduction [Week 24]

  5. Percentage of Participants Who Achieve ≥10% Body Weight Reduction [Week 48]

  6. Percentage of Participants Who Achieve ≥15% Body Weight Reduction [Week 24]

  7. Percentage of Participants Who Achieve ≥15% Body Weight Reduction [Week 48]

  8. Mean Change from Randomization in Body Weight [Randomization, Week 24]

  9. Mean Change from Randomization in Body Weight [Randomization, Week 48]

  10. Mean Change from Randomization in Body Mass Index (BMI) [Randomization, Week 24]

  11. Mean Change from Randomization in BMI [Randomization, Week 48]

  12. Mean Change from Randomization in Waist Circumference [Randomization, Week 24]

  13. 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:
No
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

SiteCityStateCountryPostal Code
1Perseverance Research CenterScottsdaleArizonaUnited States85254
2Anaheim Clinical Trials, LLCAnaheimCaliforniaUnited States92801
3Valley ResearchFresnoCaliforniaUnited States93720
4National Research Institute - Huntington ParkHuntington ParkCaliforniaUnited States90255
5National Research Institute - Huntington ParkLos AngelesCaliforniaUnited States90057
6Southern California Dermatology, Inc.Santa AnaCaliforniaUnited States92701
7Coastal Metabolic Research CentreVenturaCaliforniaUnited States93003
8Diablo Clinical Research, Inc.Walnut CreekCaliforniaUnited States94598
9Yale University School of MedicineNew HavenConnecticutUnited States06511
10East Coast Institute for Research at The Jones CenterJacksonvilleFloridaUnited States32216
11Suncoast Clinical Research, Inc.New Port RicheyFloridaUnited States34652
12Encore Medical Research - WestonWestonFloridaUnited States33331
13Springfield Diabetes & Endocrine CenterSpringfieldIllinoisUnited States62711
14Cotton O'Neil Diabetes and Endocrinology CenterTopekaKansasUnited States66606
15Tandem Clinical Research,LLCMarreroLouisianaUnited States70072
16StudyMetrix ResearchSaint PetersMissouriUnited States63303
17Palm Research Center TenayaLas VegasNevadaUnited States89128
18Amici Clinical Research LLCRaritanNew JerseyUnited States08869
19Intend Research, LLCNormanOklahomaUnited States73069
20Allegheny Endocrinology AssociatesPittsburghPennsylvaniaUnited States15212
21New Phase Research and DevelopmentKnoxvilleTennesseeUnited States37909
22Texas Diabetes & Endocrinology, P.A.AustinTexasUnited States78731
23Dallas Diabetes Research CenterDallasTexasUnited States75230
24Juno ResearchHoustonTexasUnited States77054
25Endocrine Ips, PllcHoustonTexasUnited States77079
26Southern Endocrinology AssociatesMesquiteTexasUnited States75149
27Rainier Clinical Research CenterRentonWashingtonUnited States98057
28Private Practice - Dr. Paola Mansilla-LetelierGuaynaboPuerto Rico00970
29GCM Medical Group, PSC - Hato Rey SiteSan JuanPuerto Rico00917
30San Juan City HospitalSan JuanPuerto Rico00935

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT04881760
Other Study ID Numbers:
  • 18122
  • J1I-MC-GZBF
First Posted:
May 11, 2021
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eli Lilly and Company
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021