A Study of LY3305677 in Healthy Participants

NCT02972645 | Completed Phase 1

• 2 other identifiers: 16350I8P-MC-OXAA
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety of LY3305677 and any side effects that might be associated with it. This study will also look at how much LY3305677 gets into the blood stream, how long it takes the body to remove it. This study involves a single dose of LY3305677 administered by subcutaneous injection (SC). Participation in this study is expected to last up to 16 weeks.

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

  Baseline to Study Completion (approximately 16 weeks)

Secondary Outcomes (2)

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

  Day 1 Pre-dose through Day 85

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

  Day 1 Pre-dose through Day 85

Study Arms (2)

LY3305677

EXPERIMENTAL

Single escalating doses of LY3305677 administered subcutaneously (SC)

Drug: LY3305677

Placebo

PLACEBO COMPARATOR

Placebo administered SC

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:

• Overtly healthy as determined by medical history and physical examination
• Male participants: will agree to use a reliable method of birth control and will not donate sperm during the study and for at least 3 months following the last dose of the investigational product
• Female participants: women not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause
• First generation Japanese participants or non-Japanese participants
• Have a body weight of more than 50 kilograms (kg)

You may not qualify if:

• Have participated within the last 3 months in a clinical trial involving an investigational product
• Have known allergies to glucagon-like peptide-1 (GLP-1) analogs, or any components of the formulation, or history of significant atopy
• Have an abnormality in the 12-lead electrocardiogram (ECG) at screening and/or Day -1
• Have undergone any form of bariatric surgery
• Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis
• Have a history of acute or chronic pancreatitis or elevation in serum lipase and/or amylase
• Show evidence of human immunodeficiency virus (HIV) or Hepatitis B or C
• Have used or intend to use medications that promote weight loss
• Have donated blood of more than 500 milliliter (mL) within the last month
• Currently smoke more than 10 cigarettes per 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, 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: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: November 23, 2016
• Study Start: December 5, 2016
• Primary Completion: July 14, 2017
• Study Completion: July 14, 2017
• Last Updated: July 24, 2017

Record last verified: 2017-07

Locations

GB (1)