Phase 2
Completed N=383
A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT05048719 ↗Enrolled (actual)
383
Serious AEs
4.2%
Results posted
Oct 2023
Primary outcomePrimary: Change From Baseline in HbA1c in LY3502970 as Compared to Placebo — -1.19; -1.91; -1.79; -2.03 Percentage of HbA1c — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c in LY3502970 as Compared to Placebo |
-1.19; -1.91; -1.79; -2.03; -2.10; -0.43 | <0.001 sig |
| SECONDARY Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide |
-1.19; -1.91; -1.79; -2.03; -2.10; -1.10 | 0.626 |
| SECONDARY Percentage of Participants With HbA1c ≤ 6.5% |
45.30; 70.73; 80.12; 79.39; 83.52; 14.56 | <0.001 sig |
| SECONDARY Percentage of Participants With HbA1c <7.0% |
65.17; 78.92; 91.24; 92.75; 95.76; 24.27 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Serum Glucose |
-32.6; -53.7; -52.2; -53.9; -55.9; -11.1 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight |
-3.7; -6.5; -9.7; -9.5; -10.1; -2.2 | 0.153 |
| SECONDARY Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970 |
364; 1020; 1500; 1830; 2430; 2230 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05048719). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.