A Study of Multiple Doses of LY3305677 in Healthy Participants

NCT03325387 | Completed Phase 1 FDA Drug

• 2 other identifiers: 16619I8P-MC-OXAB
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this study are to determine:

• The safety of LY3305677 and any side effects that might be associated with it.
• How much LY3305677 gets into the bloodstream and how long it takes the body to remove it in healthy participants, including those of Japanese origin.
• The effect LY3305677 has on the body, particularly the effect on blood glucose levels. This study will last approximately 17 weeks not including screening. Screening is required within 4 weeks prior to start of the study. This study is for research purposes only and is not intended to treat any medical conditions.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

  Baseline through 115 days

Secondary Outcomes (2)

• Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3305677

  Days 1 and 29: Predose through 168 hours post dose

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3305677

  Days 1 and 29: Predose through 168 hours post dose

Study Arms (2)

LY3305677

EXPERIMENTAL

Escalating doses of LY3305677 administered by subcutaneous (SC) injection

Drug: LY3305677

Placebo

PLACEBO COMPARATOR

Saline solution administered by SC injection

Drug: Placebo

Interventions

LY3305677 DRUG

Administered SC

LY3305677

Placebo DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are overtly healthy males or females, as determined by medical history and physical examination
• Women not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause
• Are first-generation Japanese or non-Japanese. First-generation Japanese is defined as the participant, the participant's biological parents, and all of the participant's grandparents are of exclusive Japanese descent and have been born in Japan
• Have a body weight of more than 54 kilograms (kg)

You may not qualify if:

• Currently enrolled in a clinical study or have participated in a study within the past 3 months
• Have an abnormality in the 12-lead electrocardiogram (ECG) at screening
• Have history of pancreatitis
• Have known or ongoing psychiatric disorders
• Have undergone bariatric surgery or have used any drugs for weight loss
• Have a history of alcoholism
• Currently smoke more than 10 cigarettes a day

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Leeds, West Yorkshire, LS2 9LH, United Kingdom

Location

MeSH Terms

Interventions

mazdutide

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: October 30, 2017
• Study Start: October 27, 2017
• Primary Completion: August 3, 2018
• Study Completion: August 3, 2018
• Last Updated: August 16, 2018

Record last verified: 2018-08

Locations

GB (1)