Trial · Interventional

CompletedPhase 2Results postedRegistry data

A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus

NCTNCT05048719Other id17787Other idJ2A-MC-GZGEOther id2021-002806-29

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 383 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Double masking
Countries: 5 countries
United States, Hungary, Poland, Puerto Rico, Slovakia
Start: 15 Sept 2021
Primary completion: 30 Sept 2022
Completion: 30 Sept 2022
First posted: 17 Sept 2021
Last update posted: 17 Oct 2023
Conditions: Type 2 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

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

202120222023

Ph 2
A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus
NCT05048719
15 Sept 2021 to 30 Sept 2022

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 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.

Interventions

LY3502970Drug
DulaglutideDrug
PlaceboDrug
PlaceboDrug

Arms9

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).
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.
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.
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.
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.
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.
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.
Active comparator
1.5 mg Dulaglutide
Participants received 1.5 mg Dulaglutide administered subcutaneously (SC) once weekly (QW).
Placebo comparator
Placebo
Participants received matching placebo.

Primary outcomes1

Outcomes the sponsor listed as primary.

Change From Baseline in HbA1c in LY3502970 as Compared to Placebo
Time frame · Baseline, Week 26
Registry description
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.

Secondary outcomes(6)

Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide
Time frame · Baseline, Week 26
Registry description
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.
Percentage of Participants With HbA1c ≤ 6.5%
Time frame · Week 26
Registry description
Percentage of Participants with HbA1c ≤ 6.5%. Odds ratio was calculated using logistic regression model.
Percentage of Participants With HbA1c <7.0%
Time frame · Week 26
Registry description
Percentage of Participants with HbA1c \<7.0%. Odds ratio was calculated using logistic regression model.
Change From Baseline in Fasting Serum Glucose
Time frame · Baseline, Week 26
Registry description
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.
Change From Baseline in Body Weight
Time frame · Baseline, Week 26
Registry description
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.
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).
Registry description
PK: Steady State AUC of LY3502970

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 outcomeLeast squares mean· Baseline, Week 26

Change From Baseline in HbA1c in LY3502970 as Compared to Placebo

Group	Value (Percentage of HbA1c)	Spread
3 mg LY3502970	-1.19	0.137
12 mg LY3502970	-1.91	0.133
24 mg LY3502970	-1.79	0.149
36 mg LY3502970	-2.03	0.127
45 mg LY3502970	-2.10	0.124
Placebo	-0.43	0.128

Secondary and other outcome results(6)

Secondary outcomeLeast squares mean· Baseline, Week 26

Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide

Group	Value (Percentage of HbA1c)	Spread
3 mg LY3502970	-1.19	0.137
12 mg LY3502970	-1.91	0.133
24 mg LY3502970	-1.79	0.149
36 mg LY3502970	-2.03	0.127
45 mg LY3502970	-2.10	0.124
1.5 mg Dulaglutide	-1.10	0.131

Secondary outcomeNumber· Week 26

Percentage of Participants With HbA1c ≤ 6.5%

Group	Value (Percentage of participants)
3 mg LY3502970	45.30
12 mg LY3502970	70.73
24 mg LY3502970	80.12
36 mg LY3502970	79.39
45 mg LY3502970	83.52
Placebo	14.56
1.5 mg Dulaglutide	41.04

Secondary outcomeNumber· Week 26

Percentage of Participants With HbA1c <7.0%

Group	Value (Percentage of participants)
3 mg LY3502970	65.17
12 mg LY3502970	78.92
24 mg LY3502970	91.24
36 mg LY3502970	92.75
45 mg LY3502970	95.76
Placebo	24.27
1.5 mg Dulaglutide	64.06

Secondary outcomeLeast squares mean· Baseline, Week 26

Change From Baseline in Fasting Serum Glucose

Group	Value (milligrams per deciliter (mg/dL))	Spread
3 mg LY3502970	-32.6	4.14
12 mg LY3502970	-53.7	3.92
24 mg LY3502970	-52.2	4.49
36 mg LY3502970	-53.9	3.79
45 mg LY3502970	-55.9	3.69
Placebo	-11.1	3.90
1.5 mg Dulaglutide	-33.2	3.91

Secondary outcomeLeast squares mean· Baseline, Week 26

Change From Baseline in Body Weight

Group	Value (kilograms (kg))	Spread
3 mg LY3502970	-3.7	0.79
12 mg LY3502970	-6.5	0.76
24 mg LY3502970	-9.7	0.85
36 mg LY3502970	-9.5	0.73
45 mg LY3502970	-10.1	0.71
Placebo	-2.2	0.74
1.5 mg Dulaglutide	-3.9	0.76

Secondary outcomeGeometric mean· 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).

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

Group	Value (nanogram hour per milliliter (ngh/mL))	Spread
3 mg LY3502970	364	38.7
12 mg LY3502970	1020	63.5
24 mg LY3502970	1500	84.5
36 mg LY3502970 - 1	1830	94.6
36 mg LY3502970 - 2	2430	39.8
45 mg LY3502970 - 1	2230	80.4
45 mg LY3502970 - 2	2550	55.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
PlaceboParticipants received matching placebo.	1 / 55	3 / 55	25 / 55
3 mg LY3502970Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally QD.	0 / 51	3 / 51	34 / 51
12 mg LY3502970Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.	0 / 56	1 / 56	40 / 56
24 mg LY3502970Participants 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.	0 / 47	5 / 47	32 / 47
36 mg LY3502970 - 1Participants 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.	0 / 27	1 / 27	21 / 27
36 mg LY3502970 - 2Participants 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.	0 / 34	1 / 34	18 / 34
45 mg LY3502970 - 1Participants 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.	0 / 31	0 / 31	21 / 31
45 mg LY3502970 - 2Participants 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.	0 / 32	1 / 32	23 / 32
1.5 mg DulaglutideParticipants received 1.5 mg Dulaglutide administered SC QW.	0 / 50	1 / 50	23 / 50

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

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CC BY8 results

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Corrected

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PMID 37369232DOI 10.1016/s0140-6736(23)01302-8PUB-37369232

Full text at the publisher

Publisher page Read the notice

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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