Diabetes Mellitus, Type 2Phase 1NCT04426474
A Study of LY3502970 in Participants With Type 2 Diabetes
A Phase 1 study testing LY3502970 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 6 sites in 2 countries.
Trial summary
The main purpose of this study is to learn more about the safety of LY3502970 and any side effects that might be associated with it. Blood tests will be done to measure how much LY3502970 is in the bloodstream, how long it takes the body to eliminate it, and how it affects blood sugar. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- LY3502970
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 8 Oct 2020to 12 Jul 2021
- Phase
- Phase 1
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have type 2 diabetes mellitus (T2DM) for at least 6 months
- Have a glycated hemoglobin (HbA1c) value at screening of greater than or equal to (≥)7.0 percent (%) and less than or equal to (≤)10.5% and are treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening
- Have a body weight of ≥45 kilograms (kg) and have a body mass index of 18.5 to 45 kilograms per square meter (kg/m²), inclusive
- Have had a stable body weight for the 3 months prior to screening (less than [<]5% body weight change)
- Males and females (not considered woman of childbearing potential)
Who cannot join
- Have type 1 diabetes mellitus, latent autoimmune diabetes in adults or have had an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening
- Have had any of the following within the past 6 months prior to screening: myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, cerebrovascular accident or decompensated congestive heart failure, or currently have New York Health Association Class III or IV heart failure
- Show evidence of hepatitis B, and/or positive hepatitis B surface antigen
- Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
- Any glucose-lowering medications other than metformin within 3 months prior to screening
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States4 sites
Midwest Clinical Research Unit
Dayton, Ohio, 45417
Clinical Pharmacology of Miami
Hialeah, Florida, 33014
Hassman Research Institute
Marlton, New Jersey, 08053
Endeavor Clinical Trials
San Antonio, Texas, 78229
Germany2 sites
Profil Mainz
Mainz, 55116
Profil Institut für Stoffwechselforschung
Neuss, North Rhine-Westphalia, 41460
About this study
Official title: A Multiple-Dose Study in Participants With Type 2 Diabetes Mellitus to Investigate the Safety, Tolerability, Pharmacokinetics,and Pharmacodynamics of LY3502970
The main purpose of this study is to learn more about the safety of LY3502970 and any side effects that might be associated with it. Blood tests will be done to measure how much LY3502970 is in the bloodstream, how long it takes the body to eliminate it, and how it affects blood sugar. Participation could last up to 18 weeks and may include up to 14 visits (including three overnight stays) in the study center.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- LY3502970, 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.
PlaceboDrug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| LY3502970 | Experimental | 3, 6, 9, 12, 15, 21, 27, 36 and 45 milligrams (mg) LY3502970 administered orally. Receives: Drug: LY3502970 |
| Placebo | Placebo comparator | Placebo administered orally. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
An SAE is defined as any untoward medical occurrence that, at any dose: Results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations based on medical judgement. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Measured: Baseline through Follow-up (up to Day 105)
Secondary outcomes (4)
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970
Measured: Day 84: Predose 0.5, 1, 2, 4, 6, 8,12, 24, 48, 96 Hours Postdose
PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours [AUC(0-24)] of LY3502970
PK: area under the concentration versus time curve from time 0 to 24 hours [AUC(0-24)] of LY3502970
Measured: Day 84: Predose 0.5, 1, 2, 4, 6, 8,12, 24 Hours Postdose
Pharmacodynamics (PD): Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)
Pharmacodynamics (PD): Change from Baseline to Week 12 in Fasting Plasma Glucose (FPG).
Measured: Baseline, Week 12
PD: Change From Baseline to Week 12 in Fasting Insulin
PD: Change From Baseline to Week 12 in Fasting Insulin.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start8 Oct 2020
- Primary completion12 Jul 2021
- Study completion12 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426474
- Sponsor's protocol ID
- 17681
- Other IDs
- J2A-MC-GZGC, 2020-000125-86
- Status last verified
- Apr 2026
- First submitted
- 8 Jun 2020
- Last updated
- 26 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No