Current partner codePEPTIDESDE
NCT02972645·Phase 1·INTERVENTIONAL

A Study of LY3305677 in Healthy Participants

Status

Completed

Phase

Phase 1

Enrollment

66

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

LY3305677

Administered SC

DRUG

Placebo

Administered SC

Timeline

From registration to results.

  1. First posted

    Nov 23, 2016

  2. Study start

    Dec 5, 2016

  3. Primary completion

    Jul 14, 2017

  4. Study completion

    Jul 14, 2017

  5. Results posted

    Not reported

  6. Registry updated

    Jul 24, 2017

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 to Study Completion (approximately 16 weeks)

Secondary outcomes

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

Time frame · Day 1 Pre-dose through Day 85

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

Time frame · Day 1 Pre-dose through Day 85

Eligibility

Who can take part.

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

Inclusion Criteria: * 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) Exclusion Criteria: * 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

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, United Kingdom

Publications

Results and literature.

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

Primary links

Continue at the source.

Related trials

More studies on Mazdutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.