A Study of LY3050258 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: LY3050258

Study type: Interventional

Funder types: Industry

Identifiers

NCT02121834

14936

I6R-MC-DLAB (Other Identifier)

Details and patient eligibility

About

This is a multiple dose study of LY3050258 in healthy men and postmenopausal women. This study will evaluate the safety and how well the body tolerates LY3050258. It will last approximately 14 weeks with a 2 week follow-up appointment after the last treatment with study drug.

Enrollment: 63 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males or healthy postmenopausal females, including Japanese participants
• Body mass index (BMI) of 18 and 35 kilograms per square meter (kg/m^2), inclusive

Exclusion criteria

• Abnormal siting blood pressure as determined by the investigator
• Abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, places the participant at an unacceptable risk for study participation
• Aspartate aminotransferase (AST) or alkaline phosphatase (ALT) greater than 2 times the upper limit of normal (ULN)
• Skin condition that in the opinion of the investigator makes the participant unsuitable for study participation
• Current use of statins within the last 3 months prior to dosing
• Current use or previous use of anabolic steroids in the preceding 6 months prior to dosing
• Use of dehydroepiandrosterone, other potential over-the-counter steroidal supplements, or other nutritional products intended to have weight-reduction and/or performance-enhancing effects within 21 days prior to dosing

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 2 patient groups, including a placebo group

LY3050258

Experimental group

Description:

Daily dose of LY3050258 for 28 days: Cohort A 10 mg, Cohort B 30 mg, Cohort C 90 mg, Cohort D 180 mg and Cohort E 360 mg.

Treatment:

Drug: Placebo

Drug: LY3050258

Placebo

Placebo Comparator group

Description:

Daily dose of placebo matching LY3050258 for 28 days.

Treatment:

Drug: Placebo

Drug: LY3050258