A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus

A Phase 2 Study of Once-Daily LY3502970 Compared With Placebo and Once-Weekly Dulaglutide in Participants With Type 2 Diabetes Mellitus

The main purpose of this study is to evaluate the efficacy and safety of LY3502970 in participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin. This study will last about 30 weeks.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Placebo; Drug: LY3502970; Drug: Placebo; Drug: Dulaglutide

• Study Type: Interventional
• Enrollment (Actual): 383
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1033
    • Clinexpert Kft.
  • Budapest, Hungary, 1032
    • Szent Margit Rendelőintézet Nonprofit Kft
  • Budapest, Hungary, 1213
    • TRANTOR'99 Bt. Anyagcsere Centrum
  • Budapest, Hungary, H1171
    • Strazsahegy Medicina Bt.
  • Budapest, Hungary, 1089
    • ClinDiab Kft.
  • Heves
    • Gyongyos, Heves, Hungary, 3200
      • Bugat Pal Korhaz
  • Zala
    • Nagykanizsa, Zala, Hungary, 8800
      • Kanizsai Dorottya Korhaz
    • Zalaegerszeg, Zala, Hungary, 8900
      • Zala Megyei Szent Rafael Kórház
• Poland
  • Dolnośląskie
    • Wrocław, Dolnośląskie, Poland, 50-403
      • Wojewódzki Zespól Specjalistycznej Opieki Zdrowotnej
  • Lubelskie
    • Lublin, Lubelskie, Poland, 20-333
      • Gabinety TERPA
    • Lublin, Lubelskie, Poland, 20-538
      • NZOZ Medica
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-507
      • Centralny Szpital Kliniczny MSWiA w Warszawie
  • Małopolskie
    • Wierzchosławice, Małopolskie, Poland, 33-122
      • Centrum Zdrowia Tuchow
  • Pomorskie
    • Gdansk, Pomorskie, Poland, 80-546
      • Centrum Badan Klinicznych PI-House sp. z o.o.
  • Łódzkie
    • Lodz, Łódzkie, Poland
      • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
  • Śląskie
    • Ruda Slaska, Śląskie, Poland, 41-709
      • NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
• Puerto Rico
  • Dorado, Puerto Rico, 00646
    • Dorado Medical Complex
  • Ponce, Puerto Rico, 00780
    • Clinical Research Management Group Inc. - Hospital San Cristobal
  • San Juan, Puerto Rico, 00907
    • BRCR Global Puerto Rico-Unda
• Slovakia
  • Nove Zamky, Slovakia, 940 01
    • Funkystuff
  • Bratislavský Kraj
    • Bratislava, Bratislavský Kraj, Slovakia, 831 06
      • Ambulancia diabetológie a porúch látkovej premeny a výživy - DIABEDA
  • Prešovský Kraj
    • Prešov, Prešovský Kraj, Slovakia, 080 01
      • Diabetol
    • Sabinov, Prešovský Kraj, Slovakia, 083 01
      • MEDI-DIA s.r.o.
  • Trenčiansky Kraj
    • Puchov, Trenčiansky Kraj, Slovakia, 020 01
      • DIA-MED CENTRUM s.r.o.
• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC
    • Huntington Park, California, United States, 90255
      • Velocity Clinical Research, Huntington Park
    • Los Angeles, California, United States, 90057
      • Velocity Clinical Research, Westlake
    • Rancho Cucamonga, California, United States, 91730
      • Rancho Cucamonga Clinical Research
    • Vallejo, California, United States, 94592
      • Touro University California
  • Colorado
    • Golden, Colorado, United States, 80401
      • New West Physicians Clinical Research
    • Monument, Colorado, United States, 80132
      • Optumcare Colorado Springs - Monument
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Clinical Research Center
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Clinvest Research LLC
  • New Jersey
    • Trenton, New Jersey, United States, 08611
      • Premier Research
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Intend Research, LLC
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Capital Area Research, LLC
    • Levittown, Pennsylvania, United States, 19056
      • Family Medical Associates
    • Philadelphia, Pennsylvania, United States, 19114
      • Tristar Clinical Investigations
  • Texas
    • Dallas, Texas, United States, 75230
      • Dallas Diabetes Research Center
    • Houston, Texas, United States, 77084
      • Biopharma Informatic, LLC
    • San Antonio, Texas, United States, 78249
      • Bandera Family Health Care
    • Shavano Park, Texas, United States, 78231
      • Consano Clinical Research, LLC
  • Washington
    • Olympia, Washington, United States, 98502
      • Capital Clinical Research Center
    • Redmond, Washington, United States, 98052
      • Eastside Research Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Have been diagnosed with Type 2 Diabetes on diet and exercise and/or a stable dose of metformin
• 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 Type 1 diabetes mellitus (T1DM) or history of ketoacidosis or hyperosmolar coma
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants received matching placebo.	Drug: Placebo; Administered orally; Drug: Placebo; Administered subcutaneously
Experimental: 3 milligrams (mg) LY3502970; Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily (QD).	Drug: LY3502970; Administered orally
Experimental: 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.	Drug: LY3502970; Administered orally
Experimental: 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.	Drug: LY3502970; Administered orally
Experimental: 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.	Drug: LY3502970; Administered orally
Experimental: 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.	Drug: LY3502970; Administered orally
Experimental: 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.	Drug: LY3502970; Administered orally
Experimental: 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.	Drug: LY3502970; Administered orally
Active Comparator: 1.5 mg Dulaglutide; Participants received 1.5 mg Dulaglutide administered subcutaneously (SC) once weekly (QW).	Drug: Dulaglutide; Administered subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in HbA1c in LY3502970 as Compared to Placebo	HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Country + Baseline HbA1c Group (<=8.0%, >8.0%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.	Baseline, Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide	HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Country + Baseline HbA1c Group (<=8.0%, >8.0%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.	Baseline, Week 26
Percentage of Participants With HbA1c ≤ 6.5%	Percentage of Participants with HbA1c ≤ 6.5%. Odds ratio was calculated using logistic regression model.	Week 26
Percentage of Participants With HbA1c <7.0%	Percentage of Participants with HbA1c <7.0%. Odds ratio was calculated using logistic regression model.	Week 26
Change From Baseline in Fasting Serum Glucose	Fasting glucose is a test to determine sugar levels in blood sample after an overnight fast. LS mean was determined by MMRM model with Baseline + Country + Baseline HbA1c Group (<=8.0%, 8.0%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.	Baseline, Week 26
Change From Baseline in Body Weight	LS mean was determined by MMRM model with Baseline + Country + Baseline HbA1c Group (<=8.0%, >8.0%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.	Baseline, Week 26
Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970	PK: Steady State AUC of LY3502970	Pre-dose (Week (wk) 0, wk 8, wk 12, and wk 26); Post-dose (wk 4, wk 8, wk 16, wk 20, and end of treatment).

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 13, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Dulaglutide
• Other Study ID Numbers: 17787 (REB); J2A-MC-GZGE (Other Identifier: Eli Lilly and Company); 2021-002806-29 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No