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Type 2 DiabetesPhase 2NCT05048719

A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus

A Phase 2 study testing LY3502970 and Dulaglutide in people with Type 2 Diabetes, run by Eli Lilly and Company at 44 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
LY3502970 and Dulaglutide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
383 participants
Where
44 sitesin 5 countries
Study dates
15 Sep 2021to 30 Sep 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

44 sites in 5 countries.

44 sites in 5 countries

United States20 sites

  • Anaheim Clinical Trials, LLC

    Anaheim, California, 92801

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania, 17011

  • Dallas Diabetes Research Center

    Dallas, Texas, 75230

  • New West Physicians Clinical Research

    Golden, Colorado, 80401

  • Biopharma Informatic, LLC

    Houston, Texas, 77084

  • Velocity Clinical Research, Huntington Park

    Huntington Park, California, 90255

  • Family Medical Associates

    Levittown, Pennsylvania, 19056

  • Velocity Clinical Research, Westlake

    Los Angeles, California, 90057

  • Optumcare Colorado Springs - Monument

    Monument, Colorado, 80132

  • Intend Research, LLC

    Norman, Oklahoma, 73069

  • Capital Clinical Research Center

    Olympia, Washington, 98502

  • Tristar Clinical Investigations

    Philadelphia, Pennsylvania, 19114

  • Rancho Cucamonga Clinical Research

    Rancho Cucamonga, California, 91730

  • Eastside Research Associates

    Redmond, Washington, 98052

  • Bandera Family Health Care

    San Antonio, Texas, 78249

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • Clinvest Research LLC

    Springfield, Missouri, 65807

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas, 66606

  • Premier Research

    Trenton, New Jersey, 08611

  • Touro University California

    Vallejo, California, 94592

Other trials in United States

Hungary8 sites

  • Szent Margit Rendelőintézet Nonprofit Kft

    Budapest, 1032

  • Clinexpert Kft.

    Budapest, 1033

  • ClinDiab Kft.

    Budapest, 1089

  • TRANTOR'99 Bt. Anyagcsere Centrum

    Budapest, 1213

  • Strazsahegy Medicina Bt.

    Budapest, H1171

  • Bugát Pál Kórház

    Gyöngyös, Heves County, 3200

  • Kanizsai Dorottya Korhaz

    Nagykanizsa, Zala County, 8800

  • Zala Megyei Szent Rafael Kórház

    Zalaegerszeg, Zala County, 8900

Other trials in Hungary

Poland8 sites

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

    Gdansk, Pomeranian Voivodeship, 80-546

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

    Lodz, Łódź Voivodeship

  • Gabinety TERPA

    Lublin, Lublin Voivodeship, 20-333

  • NZOZ Medica

    Lublin, Lublin Voivodeship, 20-538

  • NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki

    Ruda Śląska, Silesian Voivodeship, 41-709

  • Centralny Szpital Kliniczny MSWiA w Warszawie

    Warsaw, Masovian Voivodeship, 02-507

  • Centrum Zdrowia Tuchów

    Wierzchosławice, Lesser Poland Voivodeship, 33-122

  • Wojewódzki Zespól Specjalistycznej Opieki Zdrowotnej

    Wroclaw, Lower Silesian Voivodeship, 50-403

Other trials in Poland

Slovakia5 sites

  • Ambulancia diabetológie a porúch látkovej premeny a výživy - DIABEDA

    Bratislava, Bratislava Region, 831 06

  • Funkystuff

    Nové Zámky, 940 01

  • Diabetol

    Prešov, Presov, 080 01

  • DIA-MED CENTRUM s.r.o.

    Púchov, Trenčín Region, 020 01

  • MEDI-DIA s.r.o.

    Sabinov, Presov, 083 01

Other trials in Slovakia

Puerto Rico3 sites

  • Dorado Medical Complex

    Dorado, 00646

  • Clinical Research Management Group Inc. - Hospital San Cristobal

    Ponce, 00780

  • BRCR Global Puerto Rico-Unda

    San Juan, 00907

Other trials in Puerto Rico

About this study

Official title: 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.

Conditions
Type 2 Diabetes
Being tested
LY3502970, Dulaglutide, Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3502970Drug

    Administered orally

  • DulaglutideDrug

    Administered subcutaneously

  • PlaceboDrug

    Administered orally

  • PlaceboDrug

    Administered subcutaneously

Study groups in NCT05048719
Study groupRoleWhat they receive
3 milligrams (mg) LY3502970ExperimentalParticipants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily (QD).
Receives: Drug: LY3502970
12 mg LY3502970ExperimentalParticipants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.
Receives: Drug: LY3502970
24 mg LY3502970ExperimentalParticipants 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.
Receives: Drug: LY3502970
36 mg LY3502970 - 1ExperimentalParticipants 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.
Receives: Drug: LY3502970
36 mg LY3502970 - 2ExperimentalParticipants 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.
Receives: Drug: LY3502970
45 mg LY3502970 - 1ExperimentalParticipants 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.
Receives: Drug: LY3502970
45 mg LY3502970 - 2ExperimentalParticipants 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.
Receives: Drug: LY3502970
1.5 mg DulaglutideActive comparatorParticipants received 1.5 mg Dulaglutide administered subcutaneously (SC) once weekly (QW).
Receives: Drug: Dulaglutide
PlaceboPlacebo comparatorParticipants received matching placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 26

Secondary outcomes (6)

  1. 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.

    Measured: Baseline, Week 26

  2. Percentage of Participants With HbA1c ≤ 6.5%

    Percentage of Participants with HbA1c ≤ 6.5%. Odds ratio was calculated using logistic regression model.

    Measured: Week 26

  3. Percentage of Participants With HbA1c <7.0%

    Percentage of Participants with HbA1c <7.0%. Odds ratio was calculated using logistic regression model.

    Measured: Week 26

  4. 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.

    Measured: Baseline, Week 26

  5. 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.

    Measured: Baseline, Week 26

  6. Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970

    PK: Steady State AUC of LY3502970

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2021
  2. Study start15 Sep 2021
  3. Primary completion30 Sep 2022
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
383 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05048719
Sponsor's protocol ID
17787
Other IDs
J2A-MC-GZGE, 2021-002806-29
Status last verified
Sep 2023
First submitted
13 Sep 2021
Last updated
17 Oct 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 40481478

  • 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.

    PubMed 37369232

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY3502970 and Dulaglutide in people with Type 2 Diabetes, run by Eli Lilly and Company at 44 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, Hungary, Poland, Slovakia, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in HbA1c in LY3502970 as Compared to Placebo (time frame: Baseline, Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05048719, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.

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