Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as LY2409021 Test-High Formulation (high particle size), LY2409021 Test-High Formulation
LY2409021 · 9 trials · 5 indications
Systolic blood pressure obtained from Ambulatory Blood Pressure Monitoring (ABPM).
Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction.
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was calculated using a mixed-model repeated measures analysis (MMRM) that included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction.
The mean absolute change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported.
Measured by magnetic resonance (MR) scanning.
Measured by MR scanning.
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR\^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. Least Squares (LS) means were calculated using mixed effects model with fixed effects for treatment, time, period, sequence, and the time-by-treatment interaction, random effects for participant, the participant-by-treatment interaction, and participant-by-time interaction.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Single daily dose of placebo matching LY2409021 administered orally in 1 of 2 treatment periods. |
| LY2409021 | EXPERIMENTAL | Single daily dose of 20 milligrams (mg) LY2409021 administered orally in 1 of 2 treatment periods. |
| 2.5 mg LY2409021 | EXPERIMENTAL | Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician. |
| 10 mg LY2409021 | EXPERIMENTAL | Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician. |
| 20 mg LY2409021 | EXPERIMENTAL | Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician. |
| LY2409021 10 milligrams (mg) | EXPERIMENTAL | - |
| LY2409021 30 mg | EXPERIMENTAL | - |
| LY2409021 60 mg | EXPERIMENTAL | - |
| LY2409021 Control | EXPERIMENTAL | Healthy participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study. |
| LY2409021 Mild Renal Impairment | EXPERIMENTAL | Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study. |
| LY2409021 Moderate Renal Impairment | EXPERIMENTAL | Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study. |
| LY2409021 Severe Renal Impairment | EXPERIMENTAL | Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study. |
| LY2409021 End Stage Renal Disease | EXPERIMENTAL | Participants received a single 80 mg dose of LY2409021 orally on Day 1 of Period 1 of the study and a single 80 mg dose of LY2409021 orally on Day 1 of Period 2 of the study. |
| 100 mg LY2409021 | EXPERIMENTAL | LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2. Placebo: 2 capsules, administered as a single oral dose on Day 2. Glucagon: 1 mg administered via intramuscular injection on Day 3. |
| 300 mg LY2409021 | EXPERIMENTAL | LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2. Glucagon: 1 mg administered via intramuscular injection on Day 3. |
| 15 mg LY2409021 | EXPERIMENTAL | Part B - 1 capsule of 15 mg LY2409021 orally once a day for 28 days. (Arm added in September, 2012, per protocol amendment.) |
| 60 mg LY2409021 | EXPERIMENTAL | Part A - 4 capsules of 15 mg LY2409021 administered orally once a day for 28 days. |
| Part A: LY2409021 | EXPERIMENTAL | Participants will receive 2 standard meals; one alone without LY2409021, and one along with a single dose of 300 milligrams (mg) LY2409021 administered orally. Participants enrolled in Part A will not be allowed to participate in Part B. |
| Part B: LY2409021 | EXPERIMENTAL | 300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1 of the relevant treatment period. The treatment and washout period was a total of 15 days in length. |
| Part B: Placebo | PLACEBO_COMPARATOR | Administered orally as a single dose on Day 1 of the relevant treatment period. The treatment and washout period was a total of 15 days in length. |
| Part B: Moxifloxacin | ACTIVE_COMPARATOR | 400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1 of the relevant treatment period. The treatment and washout period was a total of 15 days in length. |
| 5 mg LY2409021 | EXPERIMENTAL | 5 mg LY2409021 administered orally once daily for 4 weeks |
| 30 mg LY2409021 | EXPERIMENTAL | 30 mg LY2409021 administered orally once daily for 4 weeks |
| 90 mg LY2409021 | EXPERIMENTAL | 90 mg LY2409021 administered orally once daily for 4 weeks |
| Healthy-Placebo | PLACEBO_COMPARATOR | Placebo (capsule) administered once, orally |
| Healthy-2.5 mg LY2409021 | EXPERIMENTAL | 2.5 mg LY2409021 administered once, orally |
| Healthy-10 mg LY2409021 | EXPERIMENTAL | 10 mg LY2409021 administered once, orally |
| Healthy-30 mg LY2409021 | EXPERIMENTAL | 30 mg LY2409021 administered once, orally |
| Healthy-100 mg LY2409021 | EXPERIMENTAL | 100 mg LY2409021 administered once, orally |
| Healthy-250 mg LY2409021 | EXPERIMENTAL | 250 mg LY2409021 administered once, orally |
| Healthy-500 mg LY2409021 | EXPERIMENTAL | 500 mg LY2409021 administered once, orally |
| Diabetic-Placebo | PLACEBO_COMPARATOR | Placebo (capsule) administered once, orally |
| Diabetic-75 mg LY2409021 | EXPERIMENTAL | 75 mg LY2409021 administered once, orally |
| Diabetic-200 mg LY2409021 | EXPERIMENTAL | 200 mg LY2409021 administered once, orally |
| Diabetic-500 mg LY2409021 | EXPERIMENTAL | 500 mg LY2409021 administered once, orally |
| Name | Type | Description |
|---|---|---|
| LY2409021 | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
| Metformin | DRUG | Administered as background therapy. |
| Glucagon | DRUG | Administered via intramuscular injection |
| Moxifloxacin | DRUG | Administered orally |
Inclusion Criteria: * Have type 2 diabetes mellitus (according to the World Health Organization diagnostic criteria) and use diet and exercise alone or in combination with a stable dose of metformin ( \>/=1000 mg/day \[or \<1000 mg, if documented intolerance to 1000 mg or higher dosages\] immediate...
LY2409021 is an investigational small molecule developed for metabolic conditions, specifically type 2 diabetes mellitus, type 1 diabetes mellitus, and chronic kidney failure. It has been studied in clinical trials involving participants with these conditions, including a Phase 2 study of its effects on blood pressure and pulse rate in people with type 2 diabetes.
LY2409021 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the clinical trial program for this investigational small molecule in metabolic diseases.
LY2409021 is in Phase 1 clinical development. Seven trials have been completed and none are currently active, with a total enrollment of 799 participants across the program. The studies include both Phase 1 and Phase 2 trials, and the drug remains investigational rather than approved.
Completed trials of LY2409021 include NCT02091362, a Phase 2 study of blood pressure and pulse rate in type 2 diabetes; NCT01929109, a Phase 1 study in participants with different levels of kidney function; NCT01640834, a Phase 1 study in type 1 diabetes; and NCT01606397, a Phase 1 multiple ascending dose study in type 2 diabetes.
Yes. LY2409021 is also known as LY2409021 Test-High Formulation, or the high particle size formulation. These names refer to the same investigational compound developed by Eli Lilly and Company for type 1 diabetes, type 2 diabetes, and chronic kidney failure.
LY2409021 trials were randomized, double-blind, and placebo-controlled, with 799 total participants enrolled across seven completed studies. Trials were conducted in countries including the United States, Czechia, Mexico, Poland, Puerto Rico, Germany, the United Kingdom, and Singapore, in adults with type 1 diabetes, type 2 diabetes, or chronic kidney failure.