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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03764774
- Acronym / sponsor ID
- 17110
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial was terminated due to an insufficient benefit/tolerability ratio
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 5 Dec 2018 (actual)
- Results
- Posted 4 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| 0.01 Milligram (mg) LY3463251 Part A Cohort 1 | Experimental | Drug: LY3463251Single dose of 0.01 mg LY3463251 administered subcutaneously (SC) on Day 1. |
| 0.03 mg LY3463251 Part A Cohort 2 | Experimental | Drug: LY3463251Single dose of 0.03 mg LY3463251 administered SC on Day 1. |
| 0.1 mg LY3463251 Part A Cohort 3 | Experimental | Drug: LY3463251Single dose of 0.1 mg LY3463251 administered SC on Day 1. |
| 0.3 mg LY3463251 Part A Cohort 4 | Experimental | Drug: LY3463251Single dose of 0.3 mg LY3463251 administered SC on Day 1. |
| 1 mg LY3463251 Part A Cohort 5 | Experimental | Drug: LY3463251Single dose of 1 mg LY3463251 administered SC on Day 1. |
| 3 mg LY3463251 Part A Cohort 6 | Experimental | Drug: LY3463251Single dose of 3 mg LY3463251 administered SC on Day 1. |
| 10 mg LY3463251 Part A Cohort 7 | Experimental | Drug: LY3463251Single dose of 10 mg LY3463251 administered SC on Day 1. |
| 24 mg LY3463251 Part A Cohort 8 | Experimental | Drug: LY3463251Single dose of 24 mg LY3463251 administered SC on Day 1. |
| Placebo Single Dose | Placebo comparator | Drug: PlaceboSingle dose of placebo administered SC. |
| 1 mg LY3463251 Part B Cohort 1 | Experimental | Drug: LY34632511 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. |
| 3 mg LY3465231 Part B Cohort 2 | Experimental | Drug: LY34632513 mg LY3463251 administered SC, QW for 12 weeks on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. |
| 3/6/9 mg LY3463251 Part B Cohort 3 | Experimental | Drug: LY34632513 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. |
| 3/9/15/24 mg LY3463251 Part B Cohort | Experimental | Drug: LY34632513 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. |
| Placebo Multiple Dose | Placebo comparator | Drug: PlaceboPlacebo administered SC, QW for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy males and females
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3463251Administered SC | Drug | 0.01 Milligram (mg) LY3463251 Part A Cohort 1, 0.03 mg LY3463251 Part A Cohort 2, 0.1 mg LY3463251 Part A Cohort 3, 0.3 mg LY3463251 Part A Cohort 4, 1 mg LY3463251 Part A Cohort 5, 1 mg LY3463251 Part B Cohort 1, 10 mg LY3463251 Part A Cohort 7, 24 mg LY3463251 Part A Cohort 8, 3 mg LY3463251 Part A Cohort 6, 3 mg LY3465231 Part B Cohort 2, 3/6/9 mg LY3463251 Part B Cohort 3, 3/9/15/24 mg LY3463251 Part B Cohort |
| PlaceboAdministered SC | Drug | Placebo Multiple Dose, Placebo Single Dose |
Primary outcome
Number of Participants With One or More Adverse Event(s) (AEs), All Causalities
Time frame: Baseline through follow up in Part A (up to Day 42); Baseline through follow up in Part B (up to Day 123)
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
6 secondary outcomes
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3463251 Part A
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: PD: Day -2; Predose: Day 30 and Day 85 (Part B)
Change From Baseline in Body Weight at Day 85 Part B
Time frame: Baseline, Day 85 (Part B)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36630958Benichou 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.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3463251 in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With One or More Adverse Event(s) (AEs), All Causalities (time frame: Baseline through follow up in Part A (up to Day 42); Baseline through follow up in Part B (up to Day 123)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03764774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.