Phase 2
Completed N=281
A Study of LY3437943 in Participants With Type 2 Diabetes
Source: ClinicalTrials.gov NCT04867785 ↗Enrolled (actual)
281
Serious AEs
5.3%
Results posted
Jul 2023
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) — -0.05; -1.41; -0.43; -1.39 percentage of HbA1c — p=0.188
Summary
The main purpose of this study is to evaluate the efficacy and safety of LY3437943 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 43 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) |
-0.05; -1.41; -0.43; -1.39; -1.30; -1.99 | 0.188 |
| SECONDARY Change From Baseline in HbA1c |
-0.30; -1.36; -0.54; -1.30; -1.50; -2.13 | 0.448 |
| SECONDARY Change From Baseline in HbA1c |
-0.30; -1.36; -0.54; -1.30; -1.50; -2.13 | 0.448 |
| SECONDARY Percentage of Participants Reaching HbA1c <7.0% |
18; 52; 32; 53; 66; 88 | 0.121 |
| SECONDARY Percentage of Participant Reaching HbA1c <7.0% |
22; 60; 37; 61; 59; 82 | 0.169 |
| SECONDARY Change From Baseline in Fasting Blood Glucose (FBG) |
-17.26; -27.53; -17.51; -21.46; -38.72; -69.10 | 0.984 |
| SECONDARY Change From Baseline in Fasting Blood Glucose (FBG) |
-17.26; -27.53; -17.51; -21.46; -38.72; -69.10 | 0.984 |
| SECONDARY Change From Baseline in Body Weight |
-3.28; -1.97; -3.31; -7.28; -10.37; -16.48 | 0.979 |
| SECONDARY Change From Baseline in Body Weight |
-3.28; -1.97; -3.31; -7.28; -10.37; -16.48 | 0.979 |
| SECONDARY Population PK: Average Steady-State Plasma Concentration (Cav,ss) of LY3437943 |
62.8; 466; 551; 1100; 1140; 1620 | — |
Eligibility Criteria
Inclusion Criteria
- Have Type 2 Diabetes (T2D)
- Have an HbA1c value at screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or with a stable dose of metformin (either immediate release or extended release, 1000 milligram (mg)/day and not more than the locally approved dose) for at least 3 months prior to screening.
Exclusion Criteria
- Have type 1 diabetes mellitus (T1DM)
- Have ketoacidosis
- Have retinopathy, maculopathy
- Have history of pancreatitis
- Have obesity induced by other endocrine disorders
- Have uncontrolled hypertension
- Have acute or chronic hepatitis
- Have chronic kidney disease
- Have an autoimmune abnormality for example, lupus or rheumatoid arthritis
- Have an active or untreated malignancy
Data sourced from ClinicalTrials.gov (NCT04867785). 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.