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CompletedNCT04133116Updated Nov 18, 2023

A Study of LY3471851 in Healthy Participants

A Phase 1 interventional study of LY3471851 and Placebo in Healthy, sponsored by Nektar Therapeutics. Completed at 1 site in United States. Open to participants aged 20 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by Nektar Therapeutics · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Mar 2020, 6 years 7 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
20 Years to 64 Years
Sex
All
01

Study summary

The main purpose of this study is to explore the safety and tolerability of LY3471851 in healthy Japanese and Caucasian participants. The study will also estimate how much LY3471851 gets into the blood stream and how long it takes the body to remove it. The study is expected to last about 7 weeks for each participant.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Nektar Therapeutics is the lead sponsor of 39 studies on the registry; 2 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 12 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Are healthy males or females, as determined by medical history and physical examination
  • Are first generation Japanese or are Caucasian
  • Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive, at the time of screening

Exclusion criteria

Exclusion Criteria:

  • Are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study
  • Have an abnormal blood pressure and/or pulse rate as determined by the investigator
  • Regularly use known drugs of abuse and/or show positive findings on drug screening
  • Are immunocompromised per investigator judgment
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    LY3471851

    Participants received single doses of 450 microgram (μg), 900 μg or 1800 μg LY3471851 administered subcutaneously (SC).

    Drug: LY3471851

  • Placebo comparator
    Placebo

    Placebo matching LY3471851 administered SC.

    Drug: Placebo

Interventions

  • DrugLY3471851

    Administered SC

    Also known as: NKTR-358

  • DrugPlacebo

    Administered SC

06

What researchers measure

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

    Time frame: Baseline through Study Completion (up to week 7)

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851

    PK: AUC of LY3471851

    Time frame: Predose on Day 1 through Day 50

  2. PK: Maximum Concentration (Cmax) of LY3471851

    PK: Cmax of LY3471851

    Time frame: Predose on Day 1 through Day 50

07

Study locations

1 site
  • WCCT Global
    Cypress, California 90630, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04133116
Lead sponsor
Nektar Therapeutics
Collaborators
Eli Lilly and Company
Responsible party
Sponsor
First posted
Oct 21, 2019
Start date
Oct 29, 2019
Primary completion
Mar 6, 2020
Completion
Mar 6, 2020
Last update
Nov 18, 2023

Study contacts

Study Director
study director · Nektar Therapeutics

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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