A Study of LY3025876 in Participants With Diabetes

This study is currently recruiting participants.
Verified March 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01870297
First received: May 31, 2013
Last updated: March 11, 2014
Last verified: March 2014

May 31, 2013
March 11, 2014
June 2013
July 2014   (final data collection date for primary outcome measure)
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Predose on Day 1 up to Day 56 in each Part ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01870297 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics (PK): Area under the Concentration Curve (AUC) of LY3025876 [ Time Frame: Predose on Day 1 up to 28 days after the first administration of study drug in each Part ] [ Designated as safety issue: No ]
  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3025876 [ Time Frame: Predose on Day 1 up to 28 days after the first administration of study drug in each Part ] [ Designated as safety issue: No ]
  • Part A: Immunogenicity: The Number of Participants with Anti-LY3025876 Antibodies [ Time Frame: Predose on Day 1 through Day 56 ] [ Designated as safety issue: No ]
  • Pharmacodynamics (PD): Change from Baseline to Day 28 in Fasting Glucose [ Time Frame: Baseline, Day 28 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of LY3025876 in Participants With Diabetes
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of LY3025876 in Patients With Type 2 Diabetes Mellitus

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus
  • Drug: LY3025876
    Administered SQ
  • Drug: Placebo
    Administered SQ
  • Drug: Liraglutide
    Administered SQ
  • Experimental: LY3025876
    Part A: Escalating doses (0.5 milligram [mg] up to 20 mg) of LY3025876 administered as once daily (QD) subcutaneous (SQ) injections for up to 28 days
    Intervention: Drug: LY3025876
  • Placebo Comparator: Placebo
    Part B: Placebo matching LY3025876 administered as QD SQ injections for up to 28 days
    Intervention: Drug: Placebo
  • Experimental: LY3025876 + Liraglutide
    Part B: LY3025876 (dose will be determined by Part A) and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
    Interventions:
    • Drug: LY3025876
    • Drug: Liraglutide
  • Placebo Comparator: 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.
    Interventions:
    • Drug: Placebo
    • Drug: Liraglutide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
83
November 2014
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of type 2 diabetes mellitus (T2DM) as determined by the investigator, controlled with diet or exercise alone or on a stable dose of metformin for at least 30 days
  • Have a body mass index (BMI) greater than or equal to 23 and less than or equal to 45 kilograms per square meter (kg/m^2) at screening
  • Have a supine blood pressure reading at screening of between 90-160 millimeter of mercury (mmHg) (systolic) and 40-95 mmHg (diastolic)
  • Women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause

Exclusion Criteria:

  • Have taken LY3025876 or investigational drugs like it (for example, other fibroblast growth factor-21 [FGF21]-related drugs) or have known allergies to these drugs
  • History or presence of bone disease (including osteoporosis or unhealed fractures)
  • Current active treatment of periodontal disease
  • Have had a significant change in weight, defined as a gain or loss of at least 4 kilogram (kg) (9 pounds) in the last 3 months
  • Have had greater than 1 episode of severe hypoglycemia within 6 months of screening that required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions or had a seizure or coma
  • Have known allergies or a history of intolerance to liraglutide, glucagon-like peptide 1 (GLP-1) analogues, or other related compounds
  • Have a history of acute or chronic pancreatitis
  • Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
Both
21 Years to 70 Years
No
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559
United States
 
NCT01870297
14347, I6D-MC-SMRB
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: 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
Eli Lilly and Company
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP