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NCT03325387·Phase 1·INTERVENTIONAL

A Study of Multiple Doses of LY3305677 in Healthy Participants

MazdutideOtherCompleted

Status

Completed

Phase

Phase 1

Enrollment

56

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

LY3305677

Administered SC

DRUG

Placebo

Administered SC

Timeline

From registration to results.

  1. First posted

    Oct 30, 2017

  2. Study start

    Oct 27, 2017

  3. Primary completion

    Aug 3, 2018

  4. Study completion

    Aug 3, 2018

  5. Results posted

    Not reported

  6. Registry updated

    Aug 16, 2018

Outcomes

What the study measures.

Primary outcomes

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 · Baseline through 115 days

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

Secondary outcomes

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

Time frame · Days 1 and 29: Predose through 168 hours post dose

PK: Cmax of LY3305677

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

Time frame · Days 1 and 29: Predose through 168 hours post dose

PK: AUC of LY3305677

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
Yes

Inclusion Criteria: * 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) Exclusion Criteria: * 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

Study locations

1 registered sites.

United Kingdom. Showing up to 24 locations stored in the fast local snapshot.

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, United Kingdom

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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