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| ID | Type | Description | Link |
|---|---|---|---|
| I7I-EW-XNAB | Other Identifier | Eli Lilly and Company |
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The termination criteria of the protocol was met during dose escalation.
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LY2944876 is an investigative drug for the treatment of Type 2 Diabetes Mellitus. Part A of the study will assess the safety and tolerability of single doses of LY2944876 in Japanese participants. Participation is expected to last up to about 7 weeks, not including screening.
Part B of the study will investigate the safety and tolerability of multiple doses of LY2944876 in non Japanese participants. Participation is expected to last up to about 8 weeks, not including screening.
All doses will be administered as injections into the fatty layer just beneath the skin.
Screening is required within 28 days prior to the start of the study. All participants will attend a post study safety assessment approximately 6 weeks after their final dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (Single Dose, Cohorts 1-3) | Placebo Comparator | Single dose of placebo matching LY2944876 administered subcutaneous (SC) on Day 1 |
|
| LY2944876 (Single Dose, Cohorts 1-3) | Experimental | Single dose of 10 milligrams (mg) of LY2944876 administered SC on Day 1 |
|
| Placebo (Multiple Dose, Cohort 4) | Placebo Comparator | Placebo matching LY2944876 administered once daily SC on Days 1-7 |
|
| LY2944876 (Multiple Dose, Cohort 4) | Experimental | 40 mg LY2944876 administered once daily SC on Days 1-7 |
|
| Placebo (Multiple, Cohort 5) | Placebo Comparator | Placebo matching LY2944876 administered once daily SC on Days 1, 4, 6, 8, 10 and 12 |
|
| LY2944876 (Multiple Dose, Cohort 5, Titrated) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2944876 | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to Be Related to Study Drug Administration | An SAE is any adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module. | Pre-dose (PRD) through Study Completion (Up to Day 40) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration Versus Time Curve - Time Zero to 168 Hours Post-dose [AUC(0-168h)] of LY2944876 | Cohorts1-3:Day1 PRD,8,12,24,32,48,56,72,96,168Hrs;Days15,28,42:Cohort4:Day1 PRD,12 Hrs;Days2,3,4,5,6 PRD;Day7 PRD,12,24,36,48,56,72,96,168 Hrs;Days21,34,49: Cohort 5:Day1 PRD,12,24,48 Hrs;Days4,6,8,10 PRD;Day12 PRD,12,24,36,48,56,72,96,168 Hrs;Day26,39,53 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 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. | Leeds | West Yorkshire |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A / Cohorts 1-3 - Placebo | Placebo, Single Dose Administered Subcutaneously (SC) on Day 1 |
| FG001 | Part A / Cohort 1 - 10 mg LY2944876 | 10 milligram (mg) LY2944876, Single Dose Administered SC on Day 1 |
| FG002 | Part A / Cohort 2 - 30 mg LY2944876 | 30 mg LY2944876, Single Dose Administered SC on Day 1 |
| FG003 | Part A / Cohort 3 - 50 mg LY2944876 | 50 mg LY2944876, Single Dose Administered SC on Day 1 |
| FG004 | Part B / Cohort 4 - Placebo | Placebo Administered Once Daily (QD) SC, Days 1-7 |
| FG005 | Part B / Cohort 4 - 40 mg LY2944876 | 40 mg LY2944876 Administered QD SC, Days 1-7 |
| FG006 | Part B / Cohort 5 - Placebo | Placebo Administered QD SC, Day 1, 4 and 6. |
| FG007 | Part B / Cohort 5 - 15-60 mg Titrated LY2944876 | LY2944876 Administered QD SC 15 mg on Day 1, 30 mg on Day 4 and up to 60 mg on Day 6. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A / Cohorts 1-3 - Placebo | Placebo, Single Dose Administered SC |
| BG001 | Part A / Cohort 1 - 10 mg LY2944876 | LY2944876 10 mg, Single Dose Administered SC |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age data was presented per Cohort (Part A and Part B). |
| 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 One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to Be Related to Study Drug Administration | An SAE is any adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module. | All enrolled participants, whether or not they completed all protocol requirements. | Posted | Number | Participants | Pre-dose (PRD) through Study Completion (Up to Day 40) |
|
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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 | Cohorts 1-3 - Placebo | Placebo, Single Dose Administered Subcutaneously (SC) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 17.0 | 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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LY2944876 in titrated doses of 15 mg on Day 1, 30 mg on Day 4, up to 60 mg on Day 6, and up to 80 mg on Days 8, 10 and 12 administered once daily SC |
|
| Placebo | Drug | Administered SC |
|
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2944876 |
| Cohorts1-3:Day1 PRD,8,12,24,32,48,56,72,96,168Hrs;Days15,28,42:Cohort4:Day1 PRD,12 Hrs;Days2,3,4,5,6 PRD;Day7 PRD,12,24,36,48,56,72,96,168 Hrs;Days21,34,49: Cohort 5:Day1 PRD,12,24,48 Hrs;Days4,6,8,10 PRD;Day12 PRD,12,24,36,48,56,72,96,168 Hrs;Day26,39,53 |
| United Kingdom |
| Dose Termination Criteria Met |
|
| BG002 | Part A / Cohort 2 - 30 mg LY2944876 | LY2944876 30 mg, Single Dose Administered SC |
| BG003 | Part A / Cohort 3 - 50 mg LY2944876 | LY2944876 50 mg, Single Dose Administered SC |
| BG004 | Part B / Cohort 4 - Placebo | Placebo Administered QD SC, Days 1-7 |
| BG005 | Part B / Cohort 4 - 40 mg LY2944876 | LY2944876 40 mg, Administered QD SC, Days 1-7 |
| BG006 | Part B / Cohort 5 - Placebo | Placebo, Administered QD SC, Days 1, 4 and 6. |
| BG007 | Part B / Cohort 5 - 15-60 mg Titrated LY2944876 | LY2944876 Administered QD SC 15 mg on Day 1, 30 mg on Day 4 and up to 60 mg on Day 6. |
| BG008 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Number | Participants |
|
| OG001 | Cohort 1 - 10 mg LY2944876 | 10 mg LY2944876, Single Dose Administered SC |
| OG002 | Cohort 2 - 30 mg LY2944876 | 30 mg LY2944876, Single Dose Administered SC |
| OG003 | Cohort 3 - 50 mg LY2944876 | 50 mg LY2944876, Single Dose Administered SC |
| OG004 | Cohort 4 - Placebo | Placebo Administered QD SC, Days 1-7 |
| OG005 | Cohort 4 - 40 mg LY2944876 | 40 mg LY2944876 Administered QD SC, Days 1-7 |
| OG006 | Cohort 5 - Placebo | Placebo Administered QD SC, Day 1, Day 4 and Day 6. |
| OG007 | Cohort 5 - 15-60 mg Titrated LY2944876 | LY2944876 Administered QD SC 15 mg on Day 1, 30 mg on Day 4 and up to 60 mg on Day 6. |
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration Versus Time Curve - Time Zero to 168 Hours Post-dose [AUC(0-168h)] of LY2944876 | All randomized participants receiving at least one dose of the investigational product and had evaluable AUC data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms∙hours/milliliters (ng∙h/mL) | Cohorts1-3:Day1 PRD,8,12,24,32,48,56,72,96,168Hrs;Days15,28,42:Cohort4:Day1 PRD,12 Hrs;Days2,3,4,5,6 PRD;Day7 PRD,12,24,36,48,56,72,96,168 Hrs;Days21,34,49: Cohort 5:Day1 PRD,12,24,48 Hrs;Days4,6,8,10 PRD;Day12 PRD,12,24,36,48,56,72,96,168 Hrs;Day26,39,53 |
|
|
|
| Secondary | Pharmacokinetics: Maximum Concentration (Cmax) of LY2944876 | All randomized participants receiving at least one dose of the investigational product and had evaluable Cmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Cohorts1-3:Day1 PRD,8,12,24,32,48,56,72,96,168Hrs;Days15,28,42:Cohort4:Day1 PRD,12 Hrs;Days2,3,4,5,6 PRD;Day7 PRD,12,24,36,48,56,72,96,168 Hrs;Days21,34,49: Cohort 5:Day1 PRD,12,24,48 Hrs;Days4,6,8,10 PRD;Day12 PRD,12,24,36,48,56,72,96,168 Hrs;Day26,39,53 |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Cohort 1 - LY2944876 10 mg | LY2944876 10 mg, Single Dose Administered SC | 0 | 6 | 4 | 6 |
| EG002 | Cohort 2 - LY2944876 30 mg | LY2944876 30 mg, Single Dose Administered SC | 0 | 6 | 4 | 6 |
| EG003 | Cohort 3 - LY2944876 50 mg | LY2944876 50 mg, Single Dose Administered SC | 0 | 6 | 6 | 6 |
| EG004 | Cohort 4 - Placebo | Placebo Administered QD SC, Days 1-7 | 0 | 4 | 4 | 4 |
| EG005 | Cohort 4 - LY2944876 40 mg | LY2944876 40 mg Administered QD SC, Days 1-7 | 0 | 12 | 12 | 12 |
| EG006 | Cohort 5 - Placebo | Placebo Administered QD SC, Day 1, Day 4, and Day 6. | 0 | 2 | 2 | 2 |
| EG007 | Cohort 5 - 15-80 mg Titrated LY2944876 | LY2944876 Administered QD SC 15 mg on Day 1, 30 mg on Day 4 and up to 60 mg on Day 6. | 0 | 6 | 6 | 6 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Rectal tenesmus | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Labyrinthitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Joint lock | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Ageusia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
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|
| Male |
|
|