A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities
A Phase 2 Study of Once-Daily LY3502970 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities
3 other identifiers
interventional
272
4 countries
35
Brief Summary
The main purpose of the study was to assess the effect of LY3502970 in participants who have obesity or are overweight.
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 Sep 2021
35 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
September 17, 2021
CompletedFirst Posted
Study publicly available on registry
September 21, 2021
CompletedStudy Start
First participant enrolled
September 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 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
11 months
September 17, 2021
August 23, 2023
August 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Body Weight in LY3502970 and Placebo
Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Baseline, Week 26
Secondary Outcomes (11)
Percent Change From Baseline in Body Weight in LY3502970 and Placebo
Baseline, Week 36
Change From Baseline in Body Weight in LY3502970 and Placebo
Baseline, Week 26
Change From Baseline in Body Weight in LY3502970 and Placebo
Baseline, Week 36
Change From Baseline in Waist Circumference in LY3502970 and Placebo
Baseline, Week 26
Change From Baseline in Waist Circumference in LY3502970 and Placebo
Baseline, Week 36
- +6 more secondary outcomes
Study Arms (7)
12 milligram (mg) LY3502970
EXPERIMENTALParticipants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.
24 mg LY3502970
EXPERIMENTALParticipants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.
36 mg-1 LY3502970
EXPERIMENTALParticipants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.
36 mg-2 LY3502970
EXPERIMENTALParticipants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.
45 mg-1 LY3502970
EXPERIMENTALParticipants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.
45 mg-2 LY3502970
EXPERIMENTALParticipants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.
Placebo
PLACEBO COMPARATORParticipants received placebo administered orally once daily until 36 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Have a body mass index (BMI) of ≥30-kilogram square meter (kg/m²)
- Have a BMI ≥27 kg/m² and \<30 kg/m² with at least 1 of the following weight-related comorbidities eg; \[Have hypertension, or dyslipidemia, cardiovascular disease\]
- Have had a stable body weight for the 3 months prior to randomization (not more than 5% body weight gain and/or loss)
You may not qualify if:
- Have any prior diagnosis of diabetes
- Have a prior or planned surgical treatment for obesity
- Have obesity induced by other endocrinological disorders or diagnosed monogenetic or syndromic forms of obesity
- Have renal impairment measured as estimated glomerular filtration rate (eGFR) \<30 milliliter (mL)/minute (min)/1.73 m²
- Have a history of acute chronic pancreatitis
- Within 3 months prior to screening:
- Have poorly controlled hypertension
- Have history of acute myocardial infarction
- Have history of cerebrovascular accident (stroke)
- Had hospitalization due to congestive heart failure (CHF)
- Have cancer
- Have human immunodeficiency virus (HIV) and/or positive HIV antibodies historically or at screening
- Have hepatitis B and/or positive hepatitis B surface antigen
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
John Muir Physician Network Research Center
Concord, California, 94520, United States
NorCal Medical Research, Inc
Greenbrae, California, 94904, United States
Valley Clinical Trials, Inc.
Northridge, California, 91325, United States
Norcal Endocrinology & Internal Medicine
San Ramon, California, 94583, United States
Elite Clinical Trials
Blackfoot, Idaho, 83221, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
Premier Research
Trenton, New Jersey, 08611, United States
Lillestol Research
Fargo, North Dakota, 58104, United States
Intend Research, LLC
Norman, Oklahoma, 73069, United States
Capital Area Research, LLC
Camp Hill, Pennsylvania, 17011, United States
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
Pittsburgh, Pennsylvania, 15243, United States
Dallas Diabetes Research Center
Dallas, Texas, 75230, United States
Diabetes and Thyroid Center of Fort Worth
Fort Worth, Texas, 76132, United States
Texas Diabetes & Endocrinology, P.A.
Round Rock, Texas, 78681, United States
National Clinical Research, Inc
Richmond, Virginia, 23294, United States
St. Vincent Hospital d/b/a Prevea Health
Green Bay, Wisconsin, 54303, United States
C-health Research
Calgary, Alberta, T2V 4J2, Canada
Wharton Medical Clinic
Hamilton, Ontario, L8L 5G8, Canada
Bluewater Clinical Research Group Inc.
Sarnia, Ontario, N7T 4X3, Canada
Centre Médical et Professionnel de l'Ouest de Portneuf
Saint-Marc-des-Carrieres, Quebec, G0A 4B0, Canada
Alpha Recherche Clinique
Québec, G2J 0C4, Canada
ALPHA Recherche Clinique
Québec, G3K 2P8, Canada
Studium Egeszseghaz Kft
Kalocsa, Bács-Kiskun county, 6300, Hungary
Bugát Pál Kórház
Gyöngyös, Heves County, 3200, Hungary
DRC Gyógyszervizsgáló Központ
Balatonfüred, Veszprém megye, 8230, Hungary
Kanizsai Dorottya Korhaz
Nagykanizsa, Zala County, 8800, Hungary
Szent Margit Rendelőintézet Nonprofit Kft
Budapest, 1032, Hungary
Clinexpert Kft.
Budapest, 1033, Hungary
TRANTOR'99 Bt. Anyagcsere Centrum
Budapest, 1213, Hungary
Strazsahegy Medicina Bt.
Budapest, H1171, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Puerto Rico Medical Research
Ponce, 00717, Puerto Rico
Research and Cardiovascular Corp.
Ponce, 00717, Puerto Rico
Related Publications (2)
Wharton S, Rosenstock J, Konige M, Lin Y, Duffin K, Wilson J, Banerjee H, Pirro V, Kazda C, Mather K. Treatment with orforglipron, an oral glucagon like peptide-1 receptor agonist, is associated with improvements of CV risk biomarkers in participants with type 2 diabetes or obesity without diabetes. Cardiovasc Diabetol. 2025 Jun 6;24(1):240. doi: 10.1186/s12933-025-02781-x.
PMID: 40481478DERIVEDWharton S, Blevins T, Connery L, Rosenstock J, Raha S, Liu R, Ma X, Mather KJ, Haupt A, Robins D, Pratt E, Kazda C, Konig M; GZGI Investigators. Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults with Obesity. N Engl J Med. 2023 Sep 7;389(10):877-888. doi: 10.1056/NEJMoa2302392. Epub 2023 Jun 23.
PMID: 37351564DERIVED
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 1-317-5615-4559 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
September 17, 2021
First Posted
September 21, 2021
Study Start
September 29, 2021
Primary Completion
August 25, 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.