Trial · Interventional

CompletedPhase 1Results postedRegistry data

A Study of LY3502970 in Participants With Type 2 Diabetes

NCTNCT04426474Other id17681Other idJ2A-MC-GZGCOther id2020-000125-86

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 68 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Double masking
Countries: 2 countries
United States, Germany
Start: 8 Oct 2020
Primary completion: 12 Jul 2021
Completion: 12 Jul 2021
First posted: 11 Jun 2020
Last update posted: 26 May 2026
Conditions: Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202020212022

Ph 1
A Study of LY3502970 in Participants With Type 2 Diabetes
NCT04426474
8 Oct 2020 to 12 Jul 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

LY3502970Drug
PlaceboDrug

Arms2

Experimental
LY3502970
3, 6, 9, 12, 15, 21, 27, 36 and 45 milligrams (mg) LY3502970 administered orally.
Placebo comparator
Placebo
Placebo administered orally.

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
Time frame · Baseline through Follow-up (up to Day 105)
Registry description
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.

Secondary outcomes(4)

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970
Time frame · Day 84: Predose 0.5, 1, 2, 4, 6, 8,12, 24, 48, 96 Hours Postdose
Registry description
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970
PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours [AUC(0-24)] of LY3502970
Time frame · Day 84: Predose 0.5, 1, 2, 4, 6, 8,12, 24 Hours Postdose
Registry description
PK: area under the concentration versus time curve from time 0 to 24 hours \[AUC(0-24)\] of LY3502970
Pharmacodynamics (PD): Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)
Time frame · Baseline, Week 12
Registry description
Pharmacodynamics (PD): Change from Baseline to Week 12 in Fasting Plasma Glucose (FPG).
PD: Change From Baseline to Week 12 in Fasting Insulin
Time frame · Baseline, Week 12
Registry description
PD: Change From Baseline to Week 12 in Fasting Insulin.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Baseline through Follow-up (up to Day 105)

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug

Group	Value (Participants)
Placebo QD	1
3/6/12/21 mg LY3502970 QD	0
3/6/9 mg LY3502970 QD	0
3/6/12/15 mg LY3502970 QD	0
3/6/12/21/27 mg LY3502970 QD	0
3/6/9/21/36/45 mg LY3502970 QD	0

Secondary and other outcome results(4)

Secondary outcomeGeometric mean· Day 84: Predose 0.5, 1, 2, 4, 6, 8,12, 24, 48, 96 Hours Postdose

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970

Group	Value (nanograms/milliliter (ng/mL))	Spread
3/6/12/21 mg LY3502970 QD	101	28
3/6/9 mg LY3502970 QD	57.9	78
3/6/12/15 mg LY3502970 QD	97.9	30
3/6/12/21/27 mg LY3502970 QD	191	59
3/6/9/21/36/45 mg LY3502970 QD	218	40

Secondary outcomeGeometric least squares mean· Day 84: Predose 0.5, 1, 2, 4, 6, 8,12, 24 Hours Postdose

PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours [AUC(0-24)] of LY3502970

Group	Value (nanograms hour per milliliter (ng*h/mL))	Spread
3/6/12/21 mg LY3502970 QD	1480	23
3/6/9 mg LY3502970 QD	850	73
3/6/12/15 mg LY3502970 QD	1600	29
3/6/12/21/27 mg LY3502970 QD	3120	53
3/6/9/21/36/45 mg LY3502970 QD	3520	29

Secondary outcomeLeast squares mean· Baseline, Week 12

Pharmacodynamics (PD): Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)

Group	Value (millimoles per litre (mmol/L))	Spread
Placebo QD	-1.14	0.47
3/6/12/21 mg LY3502970 QD	-2.02	0.60
3/6/9 mg LY3502970 QD	-3.00	0.54
3/6/12/15 mg LY3502970 QD	-2.85	0.55
3/6/12/21/27 mg LY3502970 QD	-2.42	0.57
3/6/9/21/36/45 mg LY3502970 QD	-2.29	0.55

Secondary outcomeMean· Baseline, Week 12

PD: Change From Baseline to Week 12 in Fasting Insulin

Group	Value (picomoles/litre (pmol/L))	Spread
Placebo QD	-9.71	11.14
3/6/12/21 mg LY3502970 QD	-12.20	13.13
3/6/9 mg LY3502970 QD	-5.46	14.48
3/6/12/15 mg LY3502970 QD	15.16	17.97
3/6/12/21/27 mg LY3502970 QD	7.30	17.09
3/6/9/21/36/45 mg LY3502970 QD	-1.32	15.63

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Placebo QDParticipants received placebo administered once daily (QD) as oral daily dosing over 12 weeks.	0 / 17	1 / 17	7 / 17
3/6/12/21 mg LY3502970 QDParticipants received 3 mg, 6 mg,12 mg and 21 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.	0 / 14	0 / 14	10 / 14
3/6/9 mg LY3502970 QDParticipants received 3 mg, 6 mg and 9 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.	0 / 9	0 / 9	8 / 9
3/6/12/15 mg LY3502970 QDParticipants received 3 mg, 6 mg,12 mg and 15 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.	0 / 10	0 / 10	9 / 10
3/6/12/21/27 mg LY3502970 QDParticipants received 3 mg, 6 mg,12 mg, 21 mg and 27 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.	0 / 9	0 / 9	8 / 9
3/6/9/21/36/45 mg LY3502970 QDParticipants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.	0 / 9	0 / 9	9 / 9

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 70 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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) Exclusion Criteria: * 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

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