A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus

September 28, 2023 updated by: Eli Lilly and Company

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
383

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c in LY3502970 as Compared to Placebo
Time Frame: Baseline, Week 26
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide
Time Frame: Baseline, Week 26
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%
Time Frame: Week 26
Percentage of Participants with HbA1c ≤ 6.5%. Odds ratio was calculated using logistic regression model.
Week 26
Percentage of Participants With HbA1c <7.0%
Time Frame: Week 26
Percentage of Participants with HbA1c <7.0%. Odds ratio was calculated using logistic regression model.
Week 26
Change From Baseline in Fasting Serum Glucose
Time Frame: Baseline, Week 26
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
Time Frame: Baseline, Week 26
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
Time Frame: 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).
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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