A Study of LY3025876 in Participants With Diabetes

This study is currently recruiting participants.
Verified April 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: April 21, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: LY3025876
Drug: Placebo
Drug: Liraglutide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of LY3025876 in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 83
Study Start Date: June 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: LY3025876
Administered SQ
Placebo Comparator: Placebo
Part B: Placebo matching LY3025876 administered as QD SQ injections for up to 28 days
Drug: Placebo
Administered SQ
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.
Drug: LY3025876
Administered SQ
Drug: Liraglutide
Administered SQ
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.
Drug: Placebo
Administered SQ
Drug: Liraglutide
Administered SQ

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01870297

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

Locations
United States, California
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. Recruiting
Chula Vista, California, United States, 91911
Contact: Eli Lilly         
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. Recruiting
Orange, California, United States, 92868
Contact: Eli Lilly         
United States, Florida
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. Recruiting
Miami, Florida, United States, 33143
Contact: Eli Lilly         
United States, Ohio
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. Not yet recruiting
Cincinnati, Ohio, United States, 45227
Contact: Eli Lilly         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01870297     History of Changes
Other Study ID Numbers: 14347, I6D-MC-SMRB
Study First Received: May 31, 2013
Last Updated: April 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 21, 2014