A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities
NCT ID: NCT05051579
Last Updated: 2023-09-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
272 participants
INTERVENTIONAL
2021-09-29
2022-11-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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12 milligram (mg) LY3502970
Participants 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.
LY3502970
Administered orally
24 mg LY3502970
Participants 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.
LY3502970
Administered orally
36 mg-1 LY3502970
Participants 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.
LY3502970
Administered orally
36 mg-2 LY3502970
Participants 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.
LY3502970
Administered orally
45 mg-1 LY3502970
Participants 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.
LY3502970
Administered orally
45 mg-2 LY3502970
Participants 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.
LY3502970
Administered orally
Placebo
Participants received placebo administered orally once daily until 36 weeks.
Placebo
Administered orally
Interventions
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LY3502970
Administered orally
Placebo
Administered orally
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
* Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within the last 2 years Note: Participants with MDD or generalized anxiety disorder whose disease state is considered stable for the past 2 years and expected to remain stable throughout the course of the study, may be considered for inclusion if they are not on excluded medications.
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
18 Years
75 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Anaheim Clinical Trials, LLC
Anaheim, California, United States
John Muir Physician Network Research Center
Concord, California, United States
NorCal Medical Research, Inc
Greenbrae, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Norcal Endocrinology & Internal Medicine
San Ramon, California, United States
Elite Clinical Trials
Blackfoot, Idaho, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States
StudyMetrix Research
City of Saint Peters, Missouri, United States
Premier Research
Trenton, New Jersey, United States
Lillestol Research
Fargo, North Dakota, United States
Intend Research, LLC
Norman, Oklahoma, United States
Capital Area Research, LLC
Camp Hill, Pennsylvania, United States
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
Pittsburgh, Pennsylvania, United States
Dallas Diabetes Research Center
Dallas, Texas, United States
Diabetes and Thyroid Center of Fort Worth
Fort Worth, Texas, United States
Texas Diabetes & Endocrinology, P.A.
Round Rock, Texas, United States
National Clinical Research, Inc
Richmond, Virginia, United States
St. Vincent Hospital d/b/a Prevea Health
Green Bay, Wisconsin, United States
C-health Research
Calgary, Alberta, Canada
Wharton Medical Clinic
Hamilton, Ontario, Canada
Bluewater Clinical Research Group Inc.
Sarnia, Ontario, Canada
Centre Médical et Professionnel de l'Ouest de Portneuf
Saint-Marc-des-Carrieres, Quebec, Canada
Alpha Recherche Clinique
Québec, , Canada
ALPHA Recherche Clinique
Québec, , Canada
Studium Egeszseghaz Kft
Kalocsa, Bács-Kiskun county, Hungary
Bugát Pál Kórház
Gyöngyös, Heves County, Hungary
DRC Gyógyszervizsgáló Központ
Balatonfüred, Veszprém megye, Hungary
Kanizsai Dorottya Korhaz
Nagykanizsa, Zala County, Hungary
Szent Margit Rendelőintézet Nonprofit Kft
Budapest, , Hungary
Clinexpert Kft.
Budapest, , Hungary
TRANTOR'99 Bt. Anyagcsere Centrum
Budapest, , Hungary
Strazsahegy Medicina Bt.
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Puerto Rico Medical Research
Ponce, , Puerto Rico
Research and Cardiovascular Corp.
Ponce, , Puerto Rico
Countries
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References
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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.
Wharton 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities
Other Identifiers
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J2A-MC-GZGI
Identifier Type: OTHER
Identifier Source: secondary_id
2021-002805-88
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
18210
Identifier Type: -
Identifier Source: org_study_id
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