A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05048719
Collaborator
(none)
370
44
8
12.3
8.4
0.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
370 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study of Once-Daily LY3502970 Compared With Placebo and Once-Weekly Dulaglutide in Participants With Type 2 Diabetes Mellitus
Actual Study Start Date :
Sep 15, 2021
Anticipated Primary Completion Date :
Sep 23, 2022
Anticipated Study Completion Date :
Sep 23, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3502970 Dose 1

Participants will receive escalated doses of LY3502970 administered orally

Drug: LY3502970
Administered orally

Experimental: LY3502970 Dose 2

Participants will receive escalated doses of LY3502970 administered orally

Drug: LY3502970
Administered orally

Experimental: LY3502970 Dose 3

Participants will receive escalated doses of LY3502970 administered orally

Drug: LY3502970
Administered orally

Experimental: LY3502970 Dose 4

Participants will receive escalated doses of LY3502970 administered orally

Drug: LY3502970
Administered orally

Experimental: LY3502970 Dose 5

Participants will receive escalated doses of LY3502970 administered orally

Drug: LY3502970
Administered orally

Active Comparator: Dulaglutide

Participants will receive Dulaglutide subcutaneously (SC)

Drug: Dulaglutide
Administered subcutaneously

Placebo Comparator: Placebo Matching LY3502970

Participants will receive placebo matching LY3502970 orally

Drug: Placebo
Administered orally

Placebo Comparator: Placebo Matching Dulaglutide

Participants will receive placebo matching Dulaglutide subcutaneously

Drug: Placebo
Administered subcutaneously

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline in Hemoglobin A1c (HbA1c) in LY3502970 and Placebo [Baseline, Week 26]

    Change from Baseline in HbA1c in LY3502970 and Placebo

Secondary Outcome Measures

  1. Change from Baseline in HbA1c in LY3502970 and Dulaglutide [Baseline, Week 26]

    Change from Baseline in HbA1c in LY3502970 and Dulaglutide

  2. Percentage of Participants with HbA1c ≤ 6.5% [Week 26]

    Percentage of Participants with HbA1c ≤ 6.5%

  3. Percentage of Participants with HbA1c <7.0% [Week 26]

    Percentage of Participants with HbA1c <7.0%

  4. Percentage of Participants in Fasting Glucose [Week 26]

    Percentage of Participants in Fasting Glucose

  5. Change from Baseline in Body Weight [Baseline, Week 26]

    Change from Baseline in Body Weight

  6. Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970 [Baseline through Week 26]

    PK: Steady State AUC of LY3502970

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05048719
Other Study ID Numbers:
  • 17787
  • J2A-MC-GZGE
  • 2021-002806-29
First Posted:
Sep 17, 2021
Last Update Posted:
Jun 22, 2022
Last Verified:
Jun 17, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2022