A Study of LY3437943 in Participants Who Have Obesity or Are Overweight
A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities
2 other identifiers
interventional
338
2 countries
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 obesity
Started May 2021
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2021
CompletedFirst Posted
Study publicly available on registry
May 11, 2021
CompletedStudy Start
First participant enrolled
May 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 22, 2022
CompletedResults Posted
Study results publicly available
September 13, 2023
CompletedSeptember 13, 2023
August 1, 2023
12 months
May 10, 2021
August 23, 2023
August 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Percent Change From Baseline in Body Weight
Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
Baseline, Week 24
Secondary Outcomes (13)
Mean Percent Change From Baseline in Body Weight
Baseline, 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
- +8 more secondary outcomes
Study Arms (7)
Placebo
PLACEBO COMPARATORParticipants received placebo matched to LY3437943 administered as subcutaneous (SC) injection once-weekly (QW).
1 milligram (mg) LY3437943
EXPERIMENTALParticipants received 1 mg LY3437943 administered as SC injection QW.
4 mg LY3437943 (2 mg)
EXPERIMENTALParticipants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
4 mg LY3437943
EXPERIMENTALParticipants received 4 mg LY3437943 administered as SC injection QW.
8 mg LY3437943 (2 mg)
EXPERIMENTALParticipants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
8 mg LY3437943 (4 mg)
EXPERIMENTALParticipants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
12 mg LY3437943 (2 mg)
EXPERIMENTALParticipants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Perseverance Research Center
Scottsdale, Arizona, 85254, United States
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Valley Research
Fresno, California, 93720, United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, 90255, United States
Velocity Clinical Research, Huntington Park
Los Angeles, California, 90057, United States
Southern California Dermatology, Inc.
Santa Ana, California, 92701, United States
Coastal Metabolic Research Centre
Ventura, California, 93003, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, 32216, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Encore Medical Research - Weston
Weston, Florida, 33331, United States
Springfield Diabetes & Endocrine Center
Springfield, Illinois, 62711, United States
Cotton O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, 66606, United States
Tandem Clinical Research,LLC
Marrero, Louisiana, 70072, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
Amici Clinical Research LLC
Raritan, New Jersey, 08869, United States
Intend Research, LLC
Norman, Oklahoma, 73069, United States
Allegheny Endocrinology Associates
Pittsburgh, Pennsylvania, 15212, United States
New Phase Research and Development
Knoxville, Tennessee, 37909, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78731, United States
Dallas Diabetes Research Center
Dallas, Texas, 75230, United States
Juno Research
Houston, Texas, 77054, United States
Endocrine Ips, Pllc
Houston, Texas, 77079, United States
Southern Endocrinology Associates
Mesquite, Texas, 75149, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Private Practice - Dr. Paola Mansilla-Letelier
Guaynabo, 00970, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
San Juan, 00917, Puerto Rico
San Juan City Hospital
San Juan, 00935, Puerto Rico
Related Publications (2)
Sanyal AJ, Kaplan LM, Frias JP, Brouwers B, Wu Q, Thomas MK, Harris C, Schloot NC, Du Y, Mather KJ, Haupt A, Hartman ML. Triple hormone receptor agonist retatrutide for metabolic dysfunction-associated steatotic liver disease: a randomized phase 2a trial. Nat Med. 2024 Jul;30(7):2037-2048. doi: 10.1038/s41591-024-03018-2. Epub 2024 Jun 10.
PMID: 38858523DERIVEDJastreboff AM, Kaplan LM, Frias JP, Wu Q, Du Y, Gurbuz S, Coskun T, Haupt A, Milicevic Z, Hartman ML; Retatrutide Phase 2 Obesity Trial Investigators. Triple-Hormone-Receptor Agonist Retatrutide for Obesity - A Phase 2 Trial. N Engl J Med. 2023 Aug 10;389(6):514-526. doi: 10.1056/NEJMoa2301972. Epub 2023 Jun 26.
PMID: 37366315DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2021
First Posted
May 11, 2021
Study Start
May 20, 2021
Primary Completion
May 16, 2022
Study Completion
November 22, 2022
Last Updated
September 13, 2023
Results First Posted
September 13, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.