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| ID | Type | Description | Link |
|---|---|---|---|
| I6D-MC-SMRB | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to assess the safety and tolerability of LY3025876 given alone (Part A) and in combination with liraglutide (Part B) in participants with type 2 diabetes mellitus (T2DM).
This study will also evaluate how much of the study drug enters the blood stream and how long it takes for the body to remove the study drug. Information about any side effects that may occur will also be collected. Participants will continue their usual diet and exercise program and may remain on their physician-prescribed dose of metformin.
Each part of the study is expected to last 10 to 12 weeks on average, not including screening. Participants may only enroll in one part.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3025876 | Experimental | Part A: 0.5 milligram (mg), 1.5 mg, 5 mg, and 15 mg of LY3025876 administered as once daily (QD) subcutaneous (SQ) injections for up to 28 days. |
|
| Placebo | Placebo Comparator | Part B: Placebo matching LY3025876 administered as QD SQ injections for up to 28 days |
|
| LY3025876 + Liraglutide | Experimental | Part B: 5.0 mg of LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks. |
|
| Placebo + Liraglutide | Placebo Comparator | Part B: Placebo doses matching LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3025876 | Drug | Administered SQ |
| |
| 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 | A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. | Predose on Day 1 up to Day 56 in each Part |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC[0-24]) of LY3025876 | AUC(0-24) of individual participants was calculated by equation Area Under Concentration (AUC)=Dose/CL, where the clearance (CL) was estimated using a population PK model. | Predose and 0.5 hour(hr), 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr Postdose |
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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. | Chula Vista | California | 91911 |
Dose escalation was planned for 20 milligrams (mg) of LY3025876 but dose escalation was only up to 15 mg LY3025876.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Part A | Part A Placebo for LY3025876 administered as once daily (QD) subcutaneous (SQ) injections for up to 28 days. |
| FG001 | 0.5 mg LY3025876 | Part A: 0.5 mg of LY3025876 administered as QD SQ injections for up to 28 days. |
| FG002 | 1.5 mg LY3025876 | Part A: 1.5 mg of LY3025876 administered as QD SQ injections for up to 28 days. |
| FG003 | 5.0 mg LY3025876 | Part A: 5.0 mg of LY3025876 administered as QD SQ injections for up to 28 days. |
| FG004 | 15 mg LY3025876 | Part A: 15 mg of LY3025876 administered as QD SQ injections for up to 28 days. |
| FG005 | Placebo + Liraglutide | Part B: Placebo doses matching LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks. |
| FG006 | 5.0 mg LY3025876 + Lirgalutide | Part B: 5.0 mg LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Part A | Part A Placebo for LY3025876 administered as QD SQ injections for up to 28 days. |
| BG001 | 0.5 mg LY3025876 | Part A: 0.5 mg of LY3025876 administered as QD SQ injections for up to 28 days. |
| 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 | 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 | Predose on Day 1 up to Day 56 in each Part |
|
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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 Part A | Part A: Placebo for LY3025876 administered as QD SQ injections for up to 28 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | (800) 545-5979 |
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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 |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| Placebo |
| Drug |
Administered SQ |
|
| Liraglutide | Drug | Administered SQ |
|
| PK: Maximum Concentration (Cmax) of LY3025876 | Days 1 and 28: Predose and 0.5 hr, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr Postdose |
| Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Predose on Day 7, 14, 28, 56, and 180 |
| Pharmacodynamics (PD): Change From Baseline to Day 28 in Fasting Glucose | Least Squares Mean (LS) Mean change from baseline in fasting glucose was modeled using Mixed Effect Model Repeat Measurement (MMRM) analysis with fixed effects of baseline, treatment, day, treatment*day interaction, and participant as a random effect. | Baseline, Day 28 |
| United States |
| 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. | Orange | California | 92868 | United States |
| 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. | Miami | Florida | 33143 | United States |
| 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. | Cincinnati | Ohio | 45227 | United States |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Sponsor Decision |
|
| BG002 | 1.5 mg LY3025876 | Part A: 1.5 mg of LY3025876 administered as QD SQ injections for up to 28 days. |
| BG003 | 5.0 mg LY3025876 | Part A: 5.0 mg of LY3025876 administered as QD SQ injections for up to 28 days. |
| BG004 | 15 mg LY3025876 | Part A: 15 mg of LY3025876 administered as QD SQ injections for up to 28 days. |
| BG005 | Placebo + Liraglutide | Part B: Placebo doses matching LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks. |
| BG006 | 5.0 mg LY3025876 + Liraglutide | Part B:5.0 mg LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks. |
| 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 | Number | participants |
|
| Glycosylated Hemoglobin (HbA1c) | Mean | Standard Deviation | percent of HbA1c |
|
| Fasting Serum Glucose (FSG) | Mean | Standard Deviation | milligram/deciliter (mg/dL) |
|
| OG002 | 1.5 mg LY3025876 | Part A: 1.5 mg of LY3025876 administered as QD SQ injections for up to 28 days. |
| OG003 | 5.0 mg LY3025876 | Part A: 5.0 mg of LY3025876 administered as QD SQ injections for up to 28 days. |
| OG004 | 15 mg LY3025876 | Part A: 15 mg of LY3025876 administered as QD SQ injections for up to 28 days. |
| OG005 | Placebo + Liraglutide | Part B: Placebo doses matching LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks. |
| OG006 | 5.0 mg LY3025876 + Liraglutide | Part B: 5.0 mg LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks. |
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC[0-24]) of LY3025876 | AUC(0-24) of individual participants was calculated by equation Area Under Concentration (AUC)=Dose/CL, where the clearance (CL) was estimated using a population PK model. | All randomized participants who received at least one dose of study drug and had evaluable AUC 0-24 PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour/milliliter (ng*hr/mL) | Predose and 0.5 hour(hr), 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr Postdose |
|
|
|
| Secondary | PK: Maximum Concentration (Cmax) of LY3025876 | All randomized participants who received at least one dose of study drug and had evaluable Cmax PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter (ng/mL) | Days 1 and 28: Predose and 0.5 hr, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr Postdose |
|
|
|
| Secondary | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | All randomized participants who received at least one dose of study drug in Part A and Part B. | Posted | Count of Participants | Participants | No | Predose on Day 7, 14, 28, 56, and 180 |
|
|
|
| Secondary | Pharmacodynamics (PD): Change From Baseline to Day 28 in Fasting Glucose | Least Squares Mean (LS) Mean change from baseline in fasting glucose was modeled using Mixed Effect Model Repeat Measurement (MMRM) analysis with fixed effects of baseline, treatment, day, treatment*day interaction, and participant as a random effect. | All randomized participants who received one dose of study drug and had evaluable PD data baseline and at least 1 post-baseline data in fasting glucose. | Posted | Least Squares Mean | Standard Error | milligram/deciliter (mg/dL) | Baseline, Day 28 |
|
|
|
| 0 |
| 11 |
| 5 |
| 11 |
| EG001 | 0.5 mg LY3025876 | Part A: 0.5 mg of LY3025876 administered as QD SQ injections for up to 28 days. | 0 | 15 | 7 | 15 |
| EG002 | 1.5 mg LY3025876 | Part A: 1.5 mg of LY3025876 administered as QD SQ injections for up to 28 days. | 0 | 8 | 8 | 8 |
| EG003 | 5.0 mg LY3025876 | Part A: 5.0 mg of LY3025876 administered as QD SQ injections for up to 28 days. | 0 | 9 | 9 | 9 |
| EG004 | 15 mg LY3025876 | Part A: 15 mg of LY3025876 administered as QD SQ injections for up to 28 days. | 0 | 10 | 10 | 10 |
| EG005 | Placebo Part B | Part B: Placebo matching LY3025876 administered as QD SQ injections for up to 28 days. | 0 | 9 | 9 | 9 |
| EG006 | Placebo + Liraglutide | Part B: Placebo doses matching LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks. | 0 | 10 | 9 | 10 |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Atrioventricular block first degree | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Infrequent bowel movements | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Early satiety | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Feeling cold | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Injection site erosion | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Injection site mass | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Injection site rash | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Temperature intolerance | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Eye contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Procedural headache | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Food aversion | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
Not provided
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
|
| Day 28 |
|
|
| Positive Antibodies Day 14 |
|
| Positive Antibodies Day 28 |
|
| Positive Antibodies Day 56 |
|
| Positive Antibodies Day 180 |
|