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| ID | Type | Description | Link |
|---|---|---|---|
| J2A-MC-GZGC | Other Identifier | Eli Lilly and Company | |
| 2020-000125-86 | EudraCT Number |
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The main purpose of this study is to learn more about the safety of LY3502970 and any side effects that might be associated with it. Blood tests will be done to measure how much LY3502970 is in the bloodstream, how long it takes the body to eliminate it, and how it affects blood sugar. Participation could last up to 18 weeks and may include up to 14 visits (including three overnight stays) in the study center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3502970 | Experimental | 3, 6, 9, 12, 15, 21, 27, 36 and 45 milligrams (mg) LY3502970 administered orally. |
|
| Placebo | Placebo Comparator | Placebo administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3502970 | Drug | Administered orally. |
| |
| Placebo |
| 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 | An SAE is defined as any untoward medical occurrence that, at any dose: Results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations based on medical judgement. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. | Baseline through Follow-up (up to Day 105) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 | Day 84: Predose 0.5, 1, 2, 4, 6, 8,12, 24, 48, 96 Hours Postdose |
| PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours [AUC(0-24)] of LY3502970 |
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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 |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami | Hialeah | Florida | 33014 | United States | ||
| Hassman Research Institute |
Not provided
| Label | URL |
|---|---|
| A Study of LY3502970 in Participants With Type 2 Diabetes | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo QD | Participants received placebo administered once daily (QD) as oral daily dosing over 12 weeks. |
| FG001 | 3/6/12/21 mg LY3502970 QD | Participants received 3 milligrams (mg), 6 mg,12 mg and 21 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks. |
| FG002 | 3/6/9 mg LY3502970 QD | Participants received 3 mg, 6 mg and 9 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks. |
| FG003 | 3/6/12/15 mg LY3502970 QD | Participants received 3 mg, 6 mg,12 mg and 15 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks. |
| FG004 | 3/6/12/21/27 mg LY3502970 QD | Participants received 3 mg, 6 mg,12 mg, 21 mg and 27 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks. |
| FG005 | 3/6/9/21/36/45 mg LY3502970 QD | Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo QD | Participants received placebo administered once daily (QD) as oral daily dosing over 12 weeks. |
| BG001 | 3/6/12/21 mg LY3502970 QD | Participants received 3 mg, 6 mg,12 mg and 21 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 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 Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug | An SAE is defined as any untoward medical occurrence that, at any dose: Results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations based on medical judgement. A summary of SAEs 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 Follow-up (up to Day 105) |
|
Baseline through Follow-up (up to Day 105)
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 QD | Participants received placebo administered once daily (QD) as oral daily dosing over 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bundle branch block left | 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 | Jan 28, 2021 | Jun 29, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 7, 2020 | Jun 29, 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 |
|---|---|
| C000729680 | orforglipron |
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| Drug |
Administered orally. |
|
PK: area under the concentration versus time curve from time 0 to 24 hours [AUC(0-24)] of LY3502970 |
| Day 84: Predose 0.5, 1, 2, 4, 6, 8,12, 24 Hours Postdose |
| Pharmacodynamics (PD): Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) | Pharmacodynamics (PD): Change from Baseline to Week 12 in Fasting Plasma Glucose (FPG). | Baseline, Week 12 |
| PD: Change From Baseline to Week 12 in Fasting Insulin | PD: Change From Baseline to Week 12 in Fasting Insulin. | Baseline, Week 12 |
| Marlton |
| New Jersey |
| 08053 |
| United States |
| Midwest Clinical Research Unit | Dayton | Ohio | 45417 | United States |
| Endeavor Clinical Trials | San Antonio | Texas | 78229 | United States |
| Profil Institut für Stoffwechselforschung | Neuss | North Rhine-Westphalia | 41460 | Germany |
| Profil Mainz | Mainz | 55116 | Germany |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| BG002 | 3/6/9 mg LY3502970 QD | Participants received 3 mg, 6 mg and 9 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks. |
| BG003 | 3/6/12/15 mg LY3502970 QD | Participants received 3 mg, 6 mg,12 mg and 15 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks. |
| BG004 | 3/6/12/21/27 mg LY3502970 QD | Participants received 3 mg, 6 mg,12 mg, 21 mg and 27 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks. |
| BG005 | 3/6/9/21/36/45 mg LY3502970 QD | Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks. |
| 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 |
|
| OG001 | 3/6/12/21 mg LY3502970 QD | Participants received 3 mg, 6 mg,12 mg and 21 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks. |
| OG002 | 3/6/9 mg LY3502970 QD | Participants received 3 mg, 6 mg and 9 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks. |
| OG003 | 3/6/12/15 mg LY3502970 QD | Participants received 3 mg, 6 mg,12 mg and 15 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks. |
| OG004 | 3/6/12/21/27 mg LY3502970 QD | Participants received 3 mg, 6 mg,12 mg, 21 mg and 27 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks. |
| OG005 | 3/6/9/21/36/45 mg LY3502970 QD | Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks. |
|
|
| Secondary | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Day 84: Predose 0.5, 1, 2, 4, 6, 8,12, 24, 48, 96 Hours Postdose |
|
|
|
| Secondary | PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours [AUC(0-24)] of LY3502970 | PK: area under the concentration versus time curve from time 0 to 24 hours [AUC(0-24)] of LY3502970 | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | nanograms hour per milliliter (ng*h/mL) | Day 84: Predose 0.5, 1, 2, 4, 6, 8,12, 24 Hours Postdose |
|
|
|
| Secondary | Pharmacodynamics (PD): Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) | Pharmacodynamics (PD): Change from Baseline to Week 12 in Fasting Plasma Glucose (FPG). | All participants who received at least one dose of study drug and had a baseline and at least one post baseline FPG value. | Posted | Least Squares Mean | Standard Error | millimoles per litre (mmol/L) | Baseline, Week 12 |
|
|
|
|
| Secondary | PD: Change From Baseline to Week 12 in Fasting Insulin | PD: Change From Baseline to Week 12 in Fasting Insulin. | All participants who received at least one dose of study drug and had a baseline and at least one post baseline fasting insulin value. | Posted | Mean | Standard Error | picomoles/litre (pmol/L) | Baseline, Week 12 |
|
|
|
|
| 0 |
| 17 |
| 1 |
| 17 |
| 7 |
| 17 |
| EG001 | 3/6/12/21 mg LY3502970 QD | Participants received 3 mg, 6 mg,12 mg and 21 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks. | 0 | 14 | 0 | 14 | 10 | 14 |
| EG002 | 3/6/9 mg LY3502970 QD | Participants received 3 mg, 6 mg and 9 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks. | 0 | 9 | 0 | 9 | 8 | 9 |
| EG003 | 3/6/12/15 mg LY3502970 QD | Participants received 3 mg, 6 mg,12 mg and 15 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks. | 0 | 10 | 0 | 10 | 9 | 10 |
| EG004 | 3/6/12/21/27 mg LY3502970 QD | Participants received 3 mg, 6 mg,12 mg, 21 mg and 27 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks. | 0 | 9 | 0 | 9 | 8 | 9 |
| EG005 | 3/6/9/21/36/45 mg LY3502970 QD | Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks. | 0 | 9 | 0 | 9 | 9 | 9 |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Breath odour | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Early satiety | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Vaccination site pain | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Covid-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Root canal infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Eyelid injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Neck injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Electrocardiogram pr prolongation | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Electrocardiogram qt prolonged | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Food aversion | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Drug withdrawal headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Listless | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
Not provided
| D004700 | Endocrine System Diseases |
| Least Squares Mean Difference |
| -1.86 |
| 2-Sided |
| 90 |
| -3.07 |
| -0.65 |
| Superiority |
| Least Squares Mean Difference | Least Squares Mean Difference | -1.70 | 2-Sided | 90 | -2.91 | -0.50 | Superiority |
| Least Squares Mean Difference | -1.28 | 2-Sided | 90 | -2.52 | -0.03 | Superiority |
| Least Squares Mean Difference | -1.14 | 2-Sided | 90 | -2.35 | 0.07 | Superiority |
| Difference in Estimated Mean Change |
| 4.24 |
| 2-Sided |
| 90 |
| -25.81 |
| 34.30 |
| Superiority |
| [Difference in Estimated Mean Change | 24.87 | 2-Sided | 90 | -9.91 | 59.65 | Superiority |
| [Difference in Estimated Mean Change | 17.01 | 2-Sided | 90 | -16.55 | 50.57 | Superiority |
| [Difference in Estimated Mean Change | 8.38 | 2-Sided | 90 | -23.19 | 39.95 | Superiority |