A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus
NCT ID: NCT05048719
Last Updated: 2023-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
383 participants
INTERVENTIONAL
2021-09-15
2022-09-30
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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3 milligrams (mg) LY3502970
Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily (QD).
LY3502970
Administered orally
12 mg LY3502970
Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.
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 QD.
LY3502970
Administered orally
36 mg LY3502970 - 1
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 QD.
LY3502970
Administered orally
36 mg LY3502970 - 2
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 QD.
LY3502970
Administered orally
45 mg LY3502970 - 1
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 QD.
LY3502970
Administered orally
45 mg LY3502970 - 2
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 QD.
LY3502970
Administered orally
1.5 mg Dulaglutide
Participants received 1.5 mg Dulaglutide administered subcutaneously (SC) once weekly (QW).
Dulaglutide
Administered subcutaneously
Placebo
Participants received matching placebo.
Placebo
Administered orally
Placebo
Administered subcutaneously
Interventions
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LY3502970
Administered orally
Dulaglutide
Administered subcutaneously
Placebo
Administered orally
Placebo
Administered subcutaneously
Eligibility Criteria
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Inclusion Criteria
* Have a stable body weight for the 3 months prior to randomization
* Have a body mass index (BMI) ≥23 kilogram/square meter (kg/m²)
* Males must agree to use highly effective methods of contraception
* Women not of childbearing potential (WNOCBP) may participate in this trial
* Note: Hormone replacement therapy in post-menopausal women is allowed but women must be on stable therapy for 3 months prior to day 1.
Exclusion Criteria
* Have a history of diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy that requires immediate treatment intervention
* Have had more than 1 episode of severe hypoglycemia and aware of hypoglycemic symptoms
* Have acute or chronic pancreatitis
* Have obesity induced other endocrine disorders (Cushing's syndrome or Prader - Willi syndrome)
* Have gastric emptying abnormality or chronically take medications impacting GI motility
* Have poorly controlled hypertension
* Have the following heart conditions within the last 6 months: myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack (TIA), cerebrovascular accident (stroke)or decompensated congestive heart failure, or IV heart failure
* Have any symptoms of other liver diseases besides nonalcoholic fatty liver disease (NAFLD)
* Have HIV, or Hepatitis B or Hepatitis C
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 1-317-615-4559 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
Velocity Clinical Research, Huntington Park
Huntington Park, California, United States
Velocity Clinical Research, Westlake
Los Angeles, California, United States
Rancho Cucamonga Clinical Research
Rancho Cucamonga, California, United States
Touro University California
Vallejo, California, United States
New West Physicians Clinical Research
Golden, Colorado, United States
Optumcare Colorado Springs - Monument
Monument, Colorado, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States
Clinvest Research LLC
Springfield, Missouri, United States
Premier Research
Trenton, New Jersey, United States
Intend Research, LLC
Norman, Oklahoma, United States
Capital Area Research, LLC
Camp Hill, Pennsylvania, United States
Family Medical Associates
Levittown, Pennsylvania, United States
Tristar Clinical Investigations
Philadelphia, Pennsylvania, United States
Dallas Diabetes Research Center
Dallas, Texas, United States
Biopharma Informatic, LLC
Houston, Texas, United States
Bandera Family Health Care
San Antonio, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Capital Clinical Research Center
Olympia, Washington, United States
Eastside Research Associates
Redmond, Washington, United States
Bugát Pál Kórház
Gyöngyös, Heves County, Hungary
Kanizsai Dorottya Korhaz
Nagykanizsa, Zala County, Hungary
Zala Megyei Szent Rafael Kórház
Zalaegerszeg, Zala County, Hungary
Szent Margit Rendelőintézet Nonprofit Kft
Budapest, , Hungary
Clinexpert Kft.
Budapest, , Hungary
ClinDiab Kft.
Budapest, , Hungary
TRANTOR'99 Bt. Anyagcsere Centrum
Budapest, , Hungary
Strazsahegy Medicina Bt.
Budapest, , Hungary
Centrum Zdrowia Tuchów
Wierzchosławice, Lesser Poland Voivodeship, Poland
Wojewódzki Zespól Specjalistycznej Opieki Zdrowotnej
Wroclaw, Lower Silesian Voivodeship, Poland
Gabinety TERPA
Lublin, Lublin Voivodeship, Poland
NZOZ Medica
Lublin, Lublin Voivodeship, Poland
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw, Masovian Voivodeship, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, Poland
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
Ruda Śląska, Silesian Voivodeship, Poland
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, Łódź Voivodeship, Poland
Dorado Medical Complex
Dorado, , Puerto Rico
Clinical Research Management Group Inc. - Hospital San Cristobal
Ponce, , Puerto Rico
BRCR Global Puerto Rico-Unda
San Juan, , Puerto Rico
Ambulancia diabetológie a porúch látkovej premeny a výživy - DIABEDA
Bratislava, Bratislava Region, Slovakia
Diabetol
Prešov, Presov, Slovakia
MEDI-DIA s.r.o.
Sabinov, Presov, Slovakia
DIA-MED CENTRUM s.r.o.
Púchov, Trenčín Region, Slovakia
Funkystuff
Nové Zámky, , Slovakia
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.
Frias JP, Hsia S, Eyde S, Liu R, Ma X, Konig M, Kazda C, Mather KJ, Haupt A, Pratt E, Robins D. Efficacy and safety of oral orforglipron in patients with type 2 diabetes: a multicentre, randomised, dose-response, phase 2 study. Lancet. 2023 Aug 5;402(10400):472-483. doi: 10.1016/S0140-6736(23)01302-8. Epub 2023 Jun 24.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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J2A-MC-GZGE
Identifier Type: OTHER
Identifier Source: secondary_id
2021-002806-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17787
Identifier Type: -
Identifier Source: org_study_id
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