A Study of LY3025876 in Participants With Diabetes

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Liraglutide

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