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| ID | Type | Description | Link |
|---|---|---|---|
| I6P-MC-FMRA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3084077 in healthy participants. The study will also investigate how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. The study is expected to last approximately 8 weeks for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Single dose of placebo matching LY3084077 administered subcutaneously (SC). |
|
| LY3084077 | Experimental | Single escalating doses (1 mg up to 300 mg) of LY3084077 administered SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Given as a SC injection. |
| |
| LY3084077 |
| 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 an 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. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. | Pre-dose, Up to Day 190 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) GLP1-Fc Domain of LY3084077 | Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose | |
| PK: Maximum Concentration (Cmax) GLP1-Fc Domain of LY3084077 |
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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. | Singapore | 117597 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Cohort 1 | Single dose of placebo matching LY3084077 administered subcutaneously (SC). |
| FG001 | LY3084077 Cohort 2 | 1 mg single dose of LY3084077 administered SC. |
| FG002 | LY3084077 Cohort 3 | 3 mg single dose of LY3084077 administered SC. |
| FG003 | LY3084077 Cohort 4 | 10 mg single dose of LY3084077 administered SC. |
| FG004 | LY3084077 Cohort 5 | 30 mg single dose of LY3084077 administered SC. |
| FG005 | LY3084077 Cohort 6 | 100 mg single dose of LY3084077 administered SC. |
| FG006 | LY3084077 Cohort 7 | 150 mg single dose of LY3084077 administered SC |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All randomized participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Cohort 1 | Single dose of placebo matching LY3084077 administered subcutaneously (SC). |
| BG001 | LY3084077 Cohort 2 | 1 mg single dose of LY3084077 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 | Mean |
| 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 an 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. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. | All randomized participants who received at least one dose of study drug. | Posted | Number | participants | Pre-dose, Up to Day 190 |
|
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All randomized participants who received at least one dose of 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 | Placebo Cohort 1 | Single dose of placebo matching LY3084077 administered SC. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| Drug |
Given as a SC injection. |
|
| Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose |
| Pharmacodynamics (PD): Percent Change From Baseline in Fasting Triglycerides | Percent change=(measure at time t-measure at baseline)/measure at baseline*100%). Least Square Means (LS means) were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction. | Baseline, Up to Day 15 |
| PD: Change From Baseline in Fasting Insulin | LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction. | Baseline, Up to Day 15 |
| PD: Change From Baseline in Weight | Baseline, Up to Day 15 |
| PD: Change From Baseline Up to Day 2 in Level of C-peptide AUC (Predose to 4 Hours) After a Standard Meal | LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction. | Baseline, Day 2 |
| PD: Change From Baseline to Day 2 Incremental AUC Level of Blood Glucose (Predose to 6 Hours) After a Standard Meal | LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction. | Baseline, Day 2 |
| PD: Change From Baseline to Day 2 in Fasting Glucagon | LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction. | Baseline, Up to Day 2 |
| Number of Participants Developing Anti-LY3084077 Antibodies | The number of participants with 1:4 baseline and postbaseline positive anti-LY3084077 antibody titers. | Pre-dose, Up to Day 190 |
| Singapore |
| BG002 | LY3084077 Cohort 3 | 3 mg single dose of LY3084077 administered SC. |
| BG003 | LY3084077 Cohort 4 | 10 mg single dose of LY3074077 administered SC. |
| BG004 | LY3084077 Cohort 5 | 30 mg single dose of LY3074077 administered SC. |
| BG005 | LY3084077 Cohort 6 | 100 mg single dose of LY3074077 administered SC. |
| BG006 | LY3084077 Cohort 7 | 150 mg single dose of LY3074077 administered SC. |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| LY3084077 Cohort 2 |
1 mg single dose of LY3084077 administered SC. |
| OG002 | LY3084077 Cohort 3 | 3 mg single dose of LY3084077 administered SC |
| OG003 | LY3084077 Cohort 4 | 10 mg single dose of LY3084077 administered SC |
| OG004 | LY3084077 Cohort 5 | 30 mg single dose of LY3084077 administered SC |
| OG005 | LY3084077 Cohort 6 | 100 mg single dose of LY3084077 administered SC |
| OG006 | LY3084077 Cohort 7 | 150 mg single dose of LY3084077 administered SC |
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) GLP1-Fc Domain of LY3084077 | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*hour/milliliter (μg•hr/mL) | Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose |
|
|
|
| Secondary | PK: Maximum Concentration (Cmax) GLP1-Fc Domain of LY3084077 | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram/milliliter (μg/mL) | Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose |
|
|
|
| Secondary | Pharmacodynamics (PD): Percent Change From Baseline in Fasting Triglycerides | Percent change=(measure at time t-measure at baseline)/measure at baseline*100%). Least Square Means (LS means) were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction. | All randomized participants who received at least one dose of study drug and had evaluable fasting triglycerides data. | Posted | Least Squares Mean | Standard Deviation | percent | Baseline, Up to Day 15 |
|
|
|
| Secondary | PD: Change From Baseline in Fasting Insulin | LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction. | All randomized participants who received at least one dose of study drug and had evaluable fasting insulin data. | Posted | Least Squares Mean | Standard Error | picomole/Liter (pmol/L) | Baseline, Up to Day 15 |
|
|
|
| Secondary | PD: Change From Baseline in Weight | Zero participants had weight measured and therefore change from baseline in weight was not calculable across all arms. | Posted | Baseline, Up to Day 15 |
|
|
| Secondary | PD: Change From Baseline Up to Day 2 in Level of C-peptide AUC (Predose to 4 Hours) After a Standard Meal | LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction. | All randomized participants who received at least one dose of study drug and had evaluable C-peptide AUC before and after a standard meal data. | Posted | Least Squares Mean | Standard Error | picomole*hour/Liter (pmol*h/L) | Baseline, Day 2 |
|
|
|
| Secondary | PD: Change From Baseline to Day 2 Incremental AUC Level of Blood Glucose (Predose to 6 Hours) After a Standard Meal | LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction. | All randomized participants who received at least one dose of study drug and had evaluable incremental glucose AUC before and after a standard meal data. | Posted | Least Squares Mean | Standard Error | millomole*hour/Liter (mmol*h/L) | Baseline, Day 2 |
|
|
|
| Secondary | PD: Change From Baseline to Day 2 in Fasting Glucagon | LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction. | All randomized participants who received at least one dose of study drug and have evaluable fasting glucagon data. | Posted | Least Squares Mean | Standard Error | pmol/L | Baseline, Up to Day 2 |
|
|
|
| Secondary | Number of Participants Developing Anti-LY3084077 Antibodies | The number of participants with 1:4 baseline and postbaseline positive anti-LY3084077 antibody titers. | All randomized participants who received at least one dose of study drug and had evaluable baseline and postbaseline antibody titers. | Posted | Number | participants | Pre-dose, Up to Day 190 |
|
|
|
| 1 |
| 6 |
| 6 |
| 6 |
| EG001 | LY3084077 Cohort 2 | 1 mg single dose of LY3084077 administered SC. | 0 | 6 | 6 | 6 |
| EG002 | LY3084077 Cohort 3 | 3 mg single dose of LY3084077 administered SC | 0 | 6 | 3 | 6 |
| EG003 | LY3084077 Cohort 4 | 10 mg single dose of LY3084077 administered SC | 0 | 6 | 3 | 6 |
| EG004 | LY3084077 Cohort 5 | 30 mg single dose of LY3084077 administered SC | 0 | 6 | 5 | 6 |
| EG005 | LY3084077 Cohort 6 | 100 mg single dose of LY3084077 administered SC | 0 | 6 | 6 | 6 |
| EG006 | LY3084077 Cohort 7 | 150 mg single dose of LY3084077 administered SC | 0 | 6 | 6 | 6 |
| Eyelid pain | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Catheter site erythema | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Catheter site haematoma | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Early satiety | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dengue fever | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
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