HealthyPhase 1NCT03764774
A Study of LY3463251 in Healthy Participants
A Phase 1 study testing LY3463251 in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability (side effects) of single (Part A) and multiple (Part B) doses of the study drug when it is administered subcutaneously (under the skin) into the abdomen. This is a two-part study. Participants will enroll in only one part. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3463251
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2018to 7 Dec 2020
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and females
Who cannot join
- Diagnosed with Type 1 or Type 2 diabetes
- Women who are of childbearing potential or who are breastfeeding
- Donated blood of more than 500 millilitres (mL) within the previous 3 months of study screening
- Have used any tobacco product within 3 months of Day -1, or are unwilling to refrain from the use of tobacco during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Inc
Daytona Beach, Florida, 32117
About this study
Official title: A Randomized, Placebo-Controlled, Subject- and Investigator-Blind, Single and Multiple Dose, Safety, Tolerability, and Pharmacokinetics Study of LY3463251 in Healthy and Overweight Healthy Subjects
The purpose of this study is to evaluate the safety and tolerability (side effects) of single (Part A) and multiple (Part B) doses of the study drug when it is administered subcutaneously (under the skin) into the abdomen.
This is a two-part study. Participants will enroll in only one part. For each participant, Part A will last about 10 weeks and Part B will last about 23 weeks, including screening.
- Conditions
- Healthy
- Being tested
- LY3463251, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3463251Drug
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| 0.01 Milligram (mg) LY3463251 Part A Cohort 1 | Experimental | Single dose of 0.01 mg LY3463251 administered subcutaneously (SC) on Day 1. Receives: Drug: LY3463251 |
| 0.03 mg LY3463251 Part A Cohort 2 | Experimental | Single dose of 0.03 mg LY3463251 administered SC on Day 1. Receives: Drug: LY3463251 |
| 0.1 mg LY3463251 Part A Cohort 3 | Experimental | Single dose of 0.1 mg LY3463251 administered SC on Day 1. Receives: Drug: LY3463251 |
| 0.3 mg LY3463251 Part A Cohort 4 | Experimental | Single dose of 0.3 mg LY3463251 administered SC on Day 1. Receives: Drug: LY3463251 |
| 1 mg LY3463251 Part A Cohort 5 | Experimental | Single dose of 1 mg LY3463251 administered SC on Day 1. Receives: Drug: LY3463251 |
| 3 mg LY3463251 Part A Cohort 6 | Experimental | Single dose of 3 mg LY3463251 administered SC on Day 1. Receives: Drug: LY3463251 |
| 10 mg LY3463251 Part A Cohort 7 | Experimental | Single dose of 10 mg LY3463251 administered SC on Day 1. Receives: Drug: LY3463251 |
| 24 mg LY3463251 Part A Cohort 8 | Experimental | Single dose of 24 mg LY3463251 administered SC on Day 1. Receives: Drug: LY3463251 |
| Placebo Single Dose | Placebo comparator | Single dose of placebo administered SC. Receives: Drug: Placebo |
| 1 mg LY3463251 Part B Cohort 1 | Experimental | 1 mg LY3463251 administered SC, once weekly (QW) for 12 weeks on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Receives: Drug: LY3463251 |
| 3 mg LY3465231 Part B Cohort 2 | Experimental | 3 mg LY3463251 administered SC, QW for 12 weeks on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Receives: Drug: LY3463251 |
| 3/6/9 mg LY3463251 Part B Cohort 3 | Experimental | 3 mg LY3463251 administered SC, QW on Days 1 and 8.
6 mg LY3463251 administered SC, QW on Days 15 and 22.
9 mg LY3463251 administered SC, QW on Days 29. 36, 43, 50, 57, 64, 71, and 78. Receives: Drug: LY3463251 |
| 3/9/15/24 mg LY3463251 Part B Cohort | Experimental | 3 mg LY3463251 administered SC, QW on Days 1 and 8.
9 mg LY3463251 administered SC, QW on Days 15 and 22.
15 mg LY3463251 administered SC, QW on Days 29 and 36.
24 mg LY3463251 administered SC, QW on Days 43, 50, 57, 64, 71, and 78. Receives: Drug: LY3463251 |
| Placebo Multiple Dose | Placebo comparator | Placebo administered SC, QW for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With One or More Adverse Event(s) (AEs), All Causalities
A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline through follow up in Part A (up to Day 42); Baseline through follow up in Part B (up to Day 123)
Secondary outcomes (6)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3463251 Part A
PK: Cmax of LY3463251
Measured: Day 1: Predose, 6, 12, 24, 48, 72, 96, 120, 168, 264, 360, 528, 696, and 1008 hr postdose
PK: Maximum Observed Concentration of LY3463251 Part B
PK: Cmax of LY3463251
Measured: Day 1: Predose, 6, 12, 24, 48, 72, and 120 hours (hr) postdose; Day 8: Predose; Day 15: Predose; Day 28: Predose; Day 57: Predose; Day 78: Predose, and Day 79: 24 hr postdose
PK: Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tlast]) of LY3463251 Part A
PK: AUC versus time curve from time zero to time t, where t is the last time point with a measurable concentration of LY3463251.
Measured: Day 1: Predose, 6, 12, 24, 48, 72, 96, 120, 168, 264, 360, 528, 696, and 1008 hr postdose
PK: Area Under the Concentration Versus Time Curve During One Dosing Interval (AUC[0-tau)] for LY3463251 Part B
PK: AUC(0-tau) of LY3463251 during one dosing interval on Day 1 and Day 78.
Measured: Day 1: Predose, 6, 12, 24, 48, 72, 120, and 168 hours (hr) postdose: Day 78: Predose, 24, 48, 168, 336, 696, 1080 hr postdose
Pharmacodynamics (PD): AUC (0-2hours) of Glucose Part B
AUC of glucose was analyzed using a model with treatment + Day + Treatment*Day + Subject + Random Error where Subject is fitted as a random effect and a repeated statement used with an Unstructured covariance structure.
Measured: PD: Day -2; Predose: Day 30 and Day 85 (Part B)
Change From Baseline in Body Weight at Day 85 Part B
Change from Baseline in Body Weight
Measured: Baseline, Day 85 (Part B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start6 Dec 2018
- Primary completion7 Dec 2020
- Study completion7 Dec 2020
Why it stopped: Trial was terminated due to an insufficient benefit/tolerability ratio
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764774
- Sponsor's protocol ID
- 17110
- Other IDs
- J1D-MC-GZAA
- Status last verified
- Oct 2025
- First submitted
- 4 Dec 2018
- Last updated
- 4 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benichou O, Coskun T, Gonciarz MD, Garhyan P, Adams AC, Du Y, Dunbar JD, Martin JA, Mather KJ, Pickard RT, Reynolds VL, Robins DA, Zvada SP, Emmerson PJ. Discovery, development, and clinical proof of mechanism of LY3463251, a long-acting GDF15 receptor agonist. Cell Metab. 2023 Feb 7;35(2):274-286.e10. doi: 10.1016/j.cmet.2022.12.011. Epub 2023 Jan 10.
PubMed 36630958