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| ID | Type | Description | Link |
|---|---|---|---|
| I4P-FW-GPFA | Other Identifier | Eli Lilly and Company |
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This will be the first study in which LY2881835 is given to humans in order to evaluate the safety and any side effects of LY2881835 in humans as well as how long LY2881835 stays in the body and its effect on blood sugar levels.
The study consists of two parts. In part A, healthy subjects will participate and in part B, patients with type 2 Diabetes Mellitus (T2DM) will participate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2881835 | Experimental | One cohort of healthy participants will receive single oral doses of LY2881835 in up to 3 of the 4 periods in Part A (dose escalation: 0.5 milligram (mg), 1.5 mg, subsequent doses determined based on review of safety, tolerability, glycaemic response and available pharmacokinetic (PK) data from the first 2 dose levels). One cohort of participants with Type 2 Diabetes Mellitus (T2DM) will receive single oral doses of LY2881835 in up to 2 of the 3 periods in Part B (dose escalation: starting dose based on review of safety, tolerability, glycaemic response and available PK data from Part A). There is a washout period of at least 5 days between periods (doses). |
|
| placebo | Placebo Comparator | One cohort of healthy participants will receive a single oral dose of placebo in 1 of the 4 periods in Part A. Another cohort of participants with T2DM will receive a single oral dose of placebo in 1 of the 3 periods in Part B. There is a washout period of at least 5 days between periods (doses). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2881835 | Drug | Administered orally |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Significant Adverse Effects | Clinically significant adverse effects are treatment emergent adverse events (TEAEs) possibly related to study drug. | Baseline to study completion up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Curve (AUC) of LY2881835 | Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only AUC from time zero to 24 hours [AUC(0-24 hours)] is provided. | Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24hours (h) post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose |
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Inclusion Criteria:
All subjects:
Subjects with Type 2 Diabetes Mellitus (T2DM) only:
Exclusion Criteria:
All subjects:
Subjects with Type 2 Diabetes Mellitus (T2DM) only:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Singapore |
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.
This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
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This is a 2-part (Part A and Part B) crossover study with four periods.In Part A, 8 participants were dosed at each dose level in 4 study periods (1 additional participant was dosed only in 1 study period). In Part B, a single cohort of 9 participants with type 2 diabetes mellitus (T2DM) participated in 3 dosing periods.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Part A (Healthy): Sequence 1 | Participants received single oral doses of 0.5 milligram (mg), 1.5 mg, 4.5 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence. Period 1: 0.5 mg LY2881835, Period 2: 1.5 mg LY2881835, Period 3: 4.5 mg LY2881835, Period 4: Placebo. |
| FG001 | Cohort 1: Part A (Healthy): Sequence 2 | Participants received single oral doses of 0.5 mg, 1.5 mg, 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence. Period 1: 0.5 mg LY2881835, Period 2: 1.5 mg LY2881835, Period 3: Placebo, Period 4: 8.4 mg LY2881835. |
| FG002 | Cohort 1: Part A (Healthy): Sequence 3 | Participants received single oral doses of 0.5 mg, 4.5 mg, 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence. Period 1: 0.5 mg LY2881835, Period 2: Placebo, Period 3: 4.5 mg LY2881835, Period 4: 8.4 mg LY2881835. |
| FG003 | Cohort 1: Part A (Healthy): Sequence 4 | Participants received single oral doses of 1.5 mg, 4.5 mg, 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence. Period 1: Placebo, Period 2: 1.5 mg LY2881835, Period 3: 4.5 mg LY2881835, Period 4: 8.4 mg LY2881835. |
| FG004 | Cohort 2: Part B (T2DM): Sequence 1 | Participants received single oral doses of 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence. Period 1: 8.4 mg LY2881835, Period 2: 8.4 mg LY2881835, Period 3: Placebo. |
| FG005 | Cohort 2: Part B (T2DM): Sequence 2 | Participants received single oral doses of 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence. Period 1: 8.4 mg LY2881835, Period 2: Placebo, Period 3: 8.4 mg LY2881835. |
| FG006 | Cohort 2: Part B (T2DM): Sequence 3 | Participants received single oral doses of 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence. Period 1: Placebo, Period 2: 8.4 mg LY2881835, Period 3: 8.4 mg LY2881835. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| |||||||||||||||||||||
| Period 2 |
| ||||||||||||||||||||||
| Period 3 |
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| Period 4 |
|
All enrolled participants who received study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Part A (Healthy): Sequence 1 | Participants received single oral doses of 0.5 milligram (mg), 1.5 mg, 4.5 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence. Period 1: 0.5 mg LY2881835, Period 2: 1.5 mg LY2881835, Period 3: 4.5 mg LY2881835, Period 4: Placebo. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Clinically Significant Adverse Effects | Clinically significant adverse effects are treatment emergent adverse events (TEAEs) possibly related to study drug. | All enrolled participants who received study drug. | Posted | Number | participants | Baseline to study completion up to 3 months |
|
Baseline to study completion up to 3 months
All enrolled participants who received study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A - Placebo | Single oral dose of placebo in a study period in Part A (Healthy). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000614377 | LY2881835 |
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| Drug |
Administered orally |
|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) Of LY2881835 | Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only Cmax up to 24 hours post-dose is provided. | Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose |
| Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY2881835 | Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only Tmax up to 24 hours post dose is provided. | Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose |
| Glucose Area Under the Effective Concentration Curve (AUEC) | Glucose area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 24 hours. | Part A: Predose, 1.0, 1.5, 2.5, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18 and 24 h post-dose; Part B: Predose, 1.0, 1.5, 2.5, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18 and 24 h post-dose |
| Glucagon-Like Peptide (Active GLP-1) Area Under the Effective Concentration Curve (AUEC) | Glucagon-like peptide (active GLP-1) area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 2.5 hours. | Part A: Predose, 1.5 and 2.5 h post-dose; Part B: Predose, 1.5 and 2.5 h post-dose |
| C-Peptide Area Under the Effective Concentration Curve (AUEC) | C-Peptide area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 6 hours. | Part A: Predose, 1.0, 1.5, 2.5, 4, 5, 6 and 24 h post-dose; Part B: Predose, 1.0, 1.5, 2.5, 4, 5, 6 and 24 h post-dose |
| Singapore |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
| Cohort 1: Part A (Healthy): Sequence 2 |
Participants received single oral doses of 0.5 mg, 1.5 mg, 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence. Period 1: 0.5 mg LY2881835, Period 2: 1.5 mg LY2881835, Period 3: Placebo, Period 4: 8.4 mg LY2881835. |
| BG002 | Cohort 1: Part A (Healthy): Sequence 3 | Participants received single oral doses of 0.5 mg, 4.5 mg, 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence. Period 1: 0.5 mg LY2881835, Period 2: Placebo, Period 3: 4.5 mg LY2881835, Period 4: 8.4 mg LY2881835. |
| BG003 | Cohort 1: Part A (Healthy): Sequence 4 | Participants received single oral doses of 1.5 mg, 4.5 mg, 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence. Period 1: Placebo, Period 2: 1.5 mg LY2881835, Period 3: 4.5 mg LY2881835, Period 4: 8.4 mg LY2881835. |
| BG004 | Cohort 2: Part B (T2DM): Sequence 1 | Participants received single oral doses of 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence. Period 1: 8.4 mg LY2881835, Period 2: 8.4 mg LY2881835, Period 3: Placebo. |
| BG005 | Cohort 2: Part B (T2DM): Sequence 2 | Participants received single oral doses of 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence. Period 1: 8.4 mg LY2881835, Period 2: Placebo, Period 3: 8.4 mg LY2881835. |
| BG006 | Cohort 2: Part B (T2DM): Sequence 3 | Participants received single oral doses of 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence. Period 1: Placebo, Period 2: 8.4 mg LY2881835, Period 3: 8.4 mg LY2881835. |
| BG007 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG002 |
| Part A - 1.5 mg LY2881835 |
Single oral dose of 1.5 mg LY2881835 in a study period in Part A (Healthy). |
| OG003 | Part A - 4.5 mg LY2881835 | Single oral dose of 4.5 mg LY2881835 in a study period in Part A (Healthy). |
| OG004 | Part A - 8.4 mg LY2881835 | Single oral dose of 8.4 mg LY2881835 in a study period in Part A (Healthy). |
| OG005 | Part B - Placebo | Single oral dose of placebo in a study period in Part B [Type 2 Diabetes Mellitus (T2DM)]. |
| OG006 | Part B - 8.4 mg LY2881835 | Single oral dose of 8.4 mg LY2881835 in 2 of the 3 study periods in Part B (T2DM). |
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Curve (AUC) of LY2881835 | Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only AUC from time zero to 24 hours [AUC(0-24 hours)] is provided. | All participants who received study drug and had evaluable PK data. Each participant in group Part B, Study Periods 1, 2 and 3 - 8.4 mg LY2881835 was dosed and had corresponding PK measures in 2 of the 3 study periods in Part B resulting in 18 samples being analyzed. Analysis used data according to the treatment the participants actually received. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour/milliliter (ng*hr/mL) | Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24hours (h) post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose | Samples | Samples |
|
|
|
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) Of LY2881835 | Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only Cmax up to 24 hours post-dose is provided. | All participants who received study drug and had evaluable PK data. Each participant in group Part B, Study Periods 1, 2 and 3 - 8.4 mg LY2881835 was dosed and had corresponding PK measures in 2 of the 3 study periods in Part B resulting in 18 samples being analyzed. Analysis used data according to the treatment the participants actually received. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose | Samples | Samples |
|
|
|
| Secondary | Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY2881835 | Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only Tmax up to 24 hours post dose is provided. | All participants who received study drug and had evaluable PK data. Each participant in group Part B, Study Periods 1, 2 and 3 - 8.4 mg LY2881835 was dosed and had corresponding PK measures in 2 of the 3 study periods in Part B resulting in 18 samples being analyzed. Analysis used data according to the treatment the participants actually received. | Posted | Median | Full Range | hours | Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose | Samples | Samples |
|
|
|
| Secondary | Glucose Area Under the Effective Concentration Curve (AUEC) | Glucose area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 24 hours. | All participants who received study drug and had evaluable glucose data. Each participant in group Part B, Study Periods (SP) 1, 2 and 3-8.4 mg LY2881835 was dosed and had corresponding glucose measures in 2 of the 3 SP in Part B resulting in 18 samples being analyzed. Analysis used data according to the treatment participants actually received. | Posted | Mean | Standard Deviation | milligrams*hour/deciliter (mg*hr/dL) | Part A: Predose, 1.0, 1.5, 2.5, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18 and 24 h post-dose; Part B: Predose, 1.0, 1.5, 2.5, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18 and 24 h post-dose | Samples | Samples |
|
|
|
| Secondary | Glucagon-Like Peptide (Active GLP-1) Area Under the Effective Concentration Curve (AUEC) | Glucagon-like peptide (active GLP-1) area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 2.5 hours. | All participants who received study drug and had evaluable GLP-1 data. Each participant in group Part B, Study Periods (SP) 1, 2 and 3-8.4 mg LY2881835 was dosed and had corresponding GLP-1 measures in 2 of the 3 SP in Part B resulting in 18 samples being analyzed. Analysis used data according to the treatment participants actually received. | Posted | Mean | Standard Deviation | picomoles*hour/liter (pmol*h/L) | Part A: Predose, 1.5 and 2.5 h post-dose; Part B: Predose, 1.5 and 2.5 h post-dose | Samples | Samples |
|
|
|
| Secondary | C-Peptide Area Under the Effective Concentration Curve (AUEC) | C-Peptide area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 6 hours. | All participants who received study drug and had evaluable C-Peptide data. Each participant in group Part B, Study Periods (SP) 1, 2, 3-8.4 mg LY2881835 was dosed and had corresponding C-Peptide measures in 2 of the 3 SP in Part B resulting in 18 samples being analyzed. Analysis used data according to the treatment participants actually received. | Posted | Mean | Standard Deviation | picomoles*hour/liter (pmol*h/L) | Part A: Predose, 1.0, 1.5, 2.5, 4, 5, 6 and 24 h post-dose; Part B: Predose, 1.0, 1.5, 2.5, 4, 5, 6 and 24 h post-dose | Samples | Samples |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 3 |
| 9 |
| EG001 | Part A - 0.5 mg LY2881835 | Single oral dose of 0.5 milligram (mg) LY2881835 in a study period in Part A (Healthy). | 0 | 6 | 0 | 6 | 3 | 6 |
| EG002 | Part A - 1.5 mg LY2881835 | Single oral dose of 1.5 mg LY2881835 in a study period in Part A (Healthy). | 0 | 6 | 0 | 6 | 3 | 6 |
| EG003 | Part A - 4.5 mg LY2881835 | Single oral dose of 4.5 mg LY2881835 in a study period in Part A (Healthy). | 0 | 6 | 0 | 6 | 2 | 6 |
| EG004 | Part A - 8.4 mg LY2881835 | Single oral dose of 8.4 mg LY2881835 in a study period in Part A (Healthy). | 0 | 6 | 0 | 6 | 4 | 6 |
| EG005 | Part B - Placebo | Single oral dose of placebo in a study period in Part B [Type 2 Diabetes Mellitus (T2DM)]. | 0 | 9 | 0 | 9 | 3 | 9 |
| EG006 | Part B - 8.4 mg LY2881835 | Single oral dose of 8.4 mg LY2881835 in 2 of the 3 study periods in Part B (T2DM). | 0 | 9 | 0 | 9 | 4 | 9 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Catheter site erythema | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hunger | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vessel puncture site swelling | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
Not provided
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| D004700 | Endocrine System Diseases |
| Samples |
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| Samples |
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| Samples |
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| Samples |
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| Samples |
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| Samples |
|