A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus

NCT05048719 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: 17787J2A-MC-GZGE2021-002806-29
• Study Type: interventional
• Target: 383
• Locations: 5 countries
• Sites: 44

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide

  Baseline, Week 26

• Percentage of Participants With HbA1c ≤ 6.5%

  Week 26

• Percentage of Participants With HbA1c <7.0%

  Week 26

• Change From Baseline in Fasting Serum Glucose

  Baseline, Week 26

• Change From Baseline in Body Weight

  Baseline, Week 26

Study Arms (9)

3 milligrams (mg) LY3502970

EXPERIMENTAL

Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily (QD).

Drug: LY3502970

12 mg LY3502970

EXPERIMENTAL

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

24 mg LY3502970

EXPERIMENTAL

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

36 mg LY3502970 - 1

EXPERIMENTAL

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

36 mg LY3502970 - 2

EXPERIMENTAL

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

45 mg LY3502970 - 1

EXPERIMENTAL

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

45 mg LY3502970 - 2

EXPERIMENTAL

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

1.5 mg Dulaglutide

ACTIVE COMPARATOR

Participants received 1.5 mg Dulaglutide administered subcutaneously (SC) once weekly (QW).

Drug: Dulaglutide

Placebo

PLACEBO COMPARATOR

Participants received matching placebo.

Drug: Placebo

Interventions

LY3502970 DRUG

Administered orally

12 mg LY3502970; 24 mg LY3502970; 3 milligrams (mg) LY3502970; 36 mg LY3502970 - 1; 36 mg LY3502970 - 2; 45 mg LY3502970 - 1; 45 mg LY3502970 - 2

Dulaglutide DRUG

Administered subcutaneously

1.5 mg Dulaglutide

Placebo DRUG

Administered orally

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (44)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Velocity Clinical Research, Huntington Park

Huntington Park, California, 90255, United States

Location

Velocity Clinical Research, Westlake

Los Angeles, California, 90057, United States

Location

Rancho Cucamonga Clinical Research

Rancho Cucamonga, California, 91730, United States

Location

Touro University California

Vallejo, California, 94592, United States

Location

New West Physicians Clinical Research

Golden, Colorado, 80401, United States

Location

Optumcare Colorado Springs - Monument

Monument, Colorado, 80132, United States

Location

Cotton O'Neil Clinical Research Center

Topeka, Kansas, 66606, United States

Location

Clinvest Research LLC

Springfield, Missouri, 65807, United States

Location

Premier Research

Trenton, New Jersey, 08611, United States

Location

Intend Research, LLC

Norman, Oklahoma, 73069, United States

Location

Capital Area Research, LLC

Camp Hill, Pennsylvania, 17011, United States

Location

Family Medical Associates

Levittown, Pennsylvania, 19056, United States

Location

Tristar Clinical Investigations

Philadelphia, Pennsylvania, 19114, United States

Location

Dallas Diabetes Research Center

Dallas, Texas, 75230, United States

Location

Biopharma Informatic, LLC

Houston, Texas, 77084, United States

Location

Bandera Family Health Care

San Antonio, Texas, 78249, United States

Location

Consano Clinical Research, LLC

Shavano Park, Texas, 78231, United States

Location

Capital Clinical Research Center

Olympia, Washington, 98502, United States

Location

Eastside Research Associates

Redmond, Washington, 98052, United States

Location

Bugát Pál Kórház

Gyöngyös, Heves County, 3200, Hungary

Location

Kanizsai Dorottya Korhaz

Nagykanizsa, Zala County, 8800, Hungary

Location

Zala Megyei Szent Rafael Kórház

Zalaegerszeg, Zala County, 8900, Hungary

Location

Szent Margit Rendelőintézet Nonprofit Kft

Budapest, 1032, Hungary

Location

Clinexpert Kft.

Budapest, 1033, Hungary

Location

ClinDiab Kft.

Budapest, 1089, Hungary

Location

TRANTOR'99 Bt. Anyagcsere Centrum

Budapest, 1213, Hungary

Location

Strazsahegy Medicina Bt.

Budapest, H1171, Hungary

Location

Centrum Zdrowia Tuchów

Wierzchosławice, Lesser Poland Voivodeship, 33-122, Poland

Location

Wojewódzki Zespól Specjalistycznej Opieki Zdrowotnej

Wroclaw, Lower Silesian Voivodeship, 50-403, Poland

Location

Gabinety TERPA

Lublin, Lublin Voivodeship, 20-333, Poland

Location

NZOZ Medica

Lublin, Lublin Voivodeship, 20-538, Poland

Location

Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, Masovian Voivodeship, 02-507, Poland

Location

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Pomeranian Voivodeship, 80-546, Poland

Location

NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki

Ruda Śląska, Silesian Voivodeship, 41-709, Poland

Location

Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

Lodz, Łódź Voivodeship, Poland

Location

Dorado Medical Complex

Dorado, 00646, Puerto Rico

Location

Clinical Research Management Group Inc. - Hospital San Cristobal

Ponce, 00780, Puerto Rico

Location

BRCR Global Puerto Rico-Unda

San Juan, 00907, Puerto Rico

Location

Ambulancia diabetológie a porúch látkovej premeny a výživy - DIABEDA

Bratislava, Bratislava Region, 831 06, Slovakia

Location

Diabetol

Prešov, Presov, 080 01, Slovakia

Location

MEDI-DIA s.r.o.

Sabinov, Presov, 083 01, Slovakia

Location

DIA-MED CENTRUM s.r.o.

Púchov, Trenčín Region, 020 01, Slovakia

Location

Funkystuff

Nové Zámky, 940 01, Slovakia

Location

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: 40481478 DERIVED

• 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.

  PMID: 37369232 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

orforglipron; dulaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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 DIRECTOR

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 13, 2021
• First Posted: September 17, 2021
• Study Start: September 15, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: October 17, 2023
• Results First Posted: October 17, 2023

Record last verified: 2023-09

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 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.

Locations

SL (5); HU (8); PR (3); US (20); PL (8)