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| ID | Type | Description | Link |
|---|---|---|---|
| J1X-MC-GZHC | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to determine the side effects related to LY3493269 in participants with type 2 diabetes. Blood tests will be performed to check concentrations of LY3493269 in the bloodstream. Each enrolled participant will receive LY3493269, dulaglutide, or placebo. The study will last up to approximately 16 weeks for each participant and may include up to 11 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.5 milligrams (mg) Dulaglutide | Active Comparator | Participants received 1.5 mg dulaglutide subcutaneously (SC) once weekly (QW) for 4 weeks. |
|
| 0.3 mg LY3493269 | Experimental | Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks. |
|
| 1 mg LY3493269 | Experimental | Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks. |
|
| 0.75/1.5/3 mg LY3493269 | Experimental | Participants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses. |
|
| 1.5/3/4/5 mg LY3493269 | Experimental | Participants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses. |
|
| Placebo | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3493269 | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence that, at any dose:
A summary of SAEs, TEAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through final follow-up at Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269 | Area Under the Concentration Versus Time Curve from Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269 | Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4. |
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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 |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States | ||
| Miami Research Associates |
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| Label | URL |
|---|---|
| A Study of LY3493269 in Participants With Type 2 Diabetes | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks. |
| FG001 | 1.5 Milligrams (mg) Dulaglutide | Participants received 1.5 mg dulaglutide SC QW for 4 weeks. |
| FG002 | 0.3 mg LY3493269 | Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks. |
| FG003 | 1 mg LY3493269 | Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks. |
| FG004 | 0.75/1.5/3 mg LY3493269 | Participants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses. |
| FG005 | 1.5/3/4/5 mg LY3493269 | Participants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks. |
| BG001 | 1.5 mg Dulaglutide | Participants received 1.5 mg dulaglutide SC QW for 4 weeks. |
| 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 Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence that, at any dose:
A summary of SAEs, TEAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline through final follow-up at Day 57 |
|
Baseline through final follow-up at Day 57
All 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 | Participants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 23.0 | 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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 16, 2021 | Aug 4, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 3, 2020 | Aug 4, 2022 | SAP_001.pdf |
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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 |
|---|---|
| C555680 | dulaglutide |
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Participants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks. |
|
| Dulaglutide | Drug | Administered SC |
|
|
| Placebo | Drug | Administered SC |
|
| PK: Maximum Observed Drug Concentration (Cmax) of LY3493269 |
Maximum Observed Drug Concentration (Cmax) of LY3493269 |
| Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4. |
| Pharmacodynamics (PD):Change From Baseline to Day 29 in Fasting Plasma Glucose | Pharmacodynamics (PD): Summary Statistics (Mean, Standard Deviation) of Change From Baseline to Day 29. | Baseline, Day 29 |
| Miami |
| Florida |
| 33143 |
| United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| BG002 | 0.3 mg LY3493269 | Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks. |
| BG003 | 1 mg LY3493269 | Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks |
| BG004 | 0.75/1.5/3 mg LY3493269 | Participants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses. |
| BG005 | 1.5/3/4/5 mg LY3493269 | Participants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| 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 |
|
| OG000 | Placebo | Participants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks. |
| OG001 | 1.5 mg Dulaglutide | Participants received 1.5 mg dulaglutide SC QW for 4 weeks. |
| OG002 | 0.3 mg LY3493269 | Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks. |
| OG003 | 1 mg LY3493269 | Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks. |
| OG004 | 0.75/1.5/3 mg LY3493269 | Participants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses. |
| OG005 | 1.5/3/4/5 mg LY3493269 | Participants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses. |
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269 | Area Under the Concentration Versus Time Curve from Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269 | All participants who received at least one dose of LY3493269 and had evaluable PK data. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*h/mL) | Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4. |
|
|
|
| Secondary | PK: Maximum Observed Drug Concentration (Cmax) of LY3493269 | Maximum Observed Drug Concentration (Cmax) of LY3493269 | All participants who received at least one dose of LY3493269 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4. |
|
|
|
| Secondary | Pharmacodynamics (PD):Change From Baseline to Day 29 in Fasting Plasma Glucose | Pharmacodynamics (PD): Summary Statistics (Mean, Standard Deviation) of Change From Baseline to Day 29. | All participants who received at least one dose of study drug and had evaluable fasting plasma glucose data. | Posted | Mean | Standard Deviation | millimoles per litre (mmol/L) | Baseline, Day 29 |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 2 |
| 7 |
| EG001 | 1.5 mg Dulaglutide QW | Participants received 1.5 mg dulaglutide SC QW for 4 weeks. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG002 | 0.3 mg LY3493269 QW | Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG003 | 1 mg LY3493269 QW | Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks. | 0 | 8 | 0 | 8 | 7 | 8 |
| EG004 | 0.75/1.5/3 mg LY3493269 QW | Participants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses. | 0 | 11 | 0 | 11 | 11 | 11 |
| EG005 | 1.5/3/4/5 mg LY3493269 QW | Participants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses. | 0 | 14 | 0 | 14 | 13 | 14 |
| Tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 23.0 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Early satiety | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Injection site haemorrhage | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Medical device site dermatitis | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Tenderness | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Vessel puncture site haemorrhage | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Epicondylitis | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Procedural nausea | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Sensitive skin | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Withdrawal hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
|
| Week 4 |
|
|
|
| Week 4 |
|
|