HypertriglyceridemiaPhase 1NCT05609825
A Study of LY3875383 in Healthy Participants and Participants With Hypertriglyceridemia
A Phase 1 study testing LY3875383 in people with Hypertriglyceridemia, run by Eli Lilly and Company at 1 site in Singapore.
Trial summary
The main purpose of this study is to determine the tolerability and side effects related to LY3875383 given as a single injection under the skin to healthy participants and participants with elevated triglyceride (TG) levels.The study will also assess how fast LY3875383 gets into the blood stream and how long the body… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- LY3875383
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteSingapore
- Study dates
- 14 Nov 2022to 10 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants:
- Have a body mass index (BMI) between 18.5 and 40 kilograms per square meter (kg/m²), inclusive.
- Males who agree to follow contraceptive requirements, or women not of childbearing potential (WNOCBP).
- Healthy participants (Part A):
- Participants must be overtly healthy, as determined by medical evaluation.
- For Part B:
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- Participants must be first-generation Japanese, defined as the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.
- Hypertriglyceridemia participants (Parts C and D):
- For Part C:
- Have history of very high triglyceride (lipid) level 500 mg/dL ≤ TG <2000 mg/dL, which needs to be further confirmed at screening.
- Participants must be on a lipid-modifying diet and can be on stable lipid-lowering drugs (LLDs) for at least 8 weeks before screening and plan to continue the same throughout the study duration.
- For Part D:
- Have history of high triglyceride (lipid) level between 150 mg/dL and 500 mg/dL inclusive at pre-screening or based on medical history and confirmed at screening and Low-density lipoprotein cholesterol (LDL-C) level of ≥40 mg/dL.
- Participants must be on a stable moderate or high-intensity dose of a statin for at least 8 weeks before screening and plan to continue the same medication and dose throughout the study duration.
Who cannot join
- All participants:
- Participants must not be currently participating in or completed a clinical trial within the last 30 days
- Have donated blood of more than 500 mL within the previous 3 months
- Have one of the following viral infections: hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV).
- Participants must not be heavy alcohol drinkers or cigarette smokers.
- For Part C: Have active pancreatitis within the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3875383 in Healthy Participants and Participants With Hypertriglyceridemia
The main purpose of this study is to determine the tolerability and side effects related to LY3875383 given as a single injection under the skin to healthy participants and participants with elevated triglyceride (TG) levels.The study will also assess how fast LY3875383 gets into the blood stream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of either LY3875383 or placebo.The study will be conducted in four parts (A, B, C and D) and may last up to approximately 28 to 56 weeks including screening.
- Conditions
- Hypertriglyceridemia
- Being tested
- LY3875383, Placebo
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3875383Drug
Administered SC.
PlaceboDrug
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| LY3875383 (Part A) | Experimental | Single-ascending doses of LY3875383 administered subcutaneously (SC). Receives: Drug: LY3875383 |
| LY3875383 (Part B) | Experimental | Single doses of LY3875383 administered SC. Receives: Drug: LY3875383 |
| LY3875383 (Part C) | Experimental | Single doses of LY3875383 administered SC. Receives: Drug: LY3875383 |
| LY3875383 (Part D) | Experimental | Single doses of LY3875383 administered SC. Receives: Drug: LY3875383 |
| Placebo (Part A) | Placebo comparator | Placebo administered SC. Receives: Drug: Placebo |
| Placebo (Part B) | Placebo comparator | Placebo administered SC. Receives: Drug: Placebo |
| Placebo (Part C) | Placebo comparator | Placebo administered SC. Receives: Drug: Placebo |
| Placebo (Part D) | Placebo comparator | Placebo administered SC. 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 Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline through Week 53
Secondary outcomes (4)
Pharmacokinetics (PK):Area Under the Concentration Versus Time Curve (AUC) of LY3875383
PK: AUC of LY3875383
Measured: Predose up to Day 8 post dose
PK: Maximum Observed Concentration (Cmax) of LY3875383
PK: Cmax of LY3875383
Measured: Predose up to Day 8 post dose
Part C and D only: Pharmacodynamics (PD): Percentage Change from Baseline in Fasting Triglyceride (TG)
Part C and D only: PD: Percentage Change from Baseline in Fasting TG
Measured: Baseline through up to Week 53
Part D only: PD: Percentage Change from Baseline in Fasting Non-High-Density Lipoprotein Cholesterol (HDL-C)
Part D only: PD: Percentage Change from Baseline in Fasting non-HDL-C
Measured: Baseline through Week 53
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start14 Nov 2022
- Primary completion10 Jan 2024
- Study completion10 Jan 2024
Why it stopped: The study was terminated due to a change in risk/benefit ratio, which no longer favoured continued development.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies 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
- 41 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
- NCT05609825
- Sponsor's protocol ID
- 18537
- Other IDs
- J4D-MC-EZFA
- Status last verified
- May 2025
- First submitted
- 4 Nov 2022
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3875383 in Healthy Participants and Participants With Hypertriglyceridemia
- ClinicalTrials.gov ID
- NCT05609825
- Acronym / sponsor ID
- 18537
- Conditions
- Hypertriglyceridemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to a change in risk/benefit ratio, which no longer favoured continued development.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to determine the tolerability and side effects related to LY3875383 given as a single injection under the skin to healthy participants and participants with elevated triglyceride (TG) levels.The study will also assess how fast LY3875383 gets into the blood stream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of either LY3875383 or placebo.The study will be conducted in four parts (A, B, C and D) and may last up to approximately 28 to 56 weeks including screening.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| LY3875383 (Part A) | Experimental | Drug: LY3875383Single-ascending doses of LY3875383 administered subcutaneously (SC). |
| LY3875383 (Part B) | Experimental | Drug: LY3875383Single doses of LY3875383 administered SC. |
| LY3875383 (Part C) | Experimental | Drug: LY3875383Single doses of LY3875383 administered SC. |
| LY3875383 (Part D) | Experimental | Drug: LY3875383Single doses of LY3875383 administered SC. |
| Placebo (Part A) | Placebo comparator | Drug: PlaceboPlacebo administered SC. |
| Placebo (Part B) | Placebo comparator | Drug: PlaceboPlacebo administered SC. |
| Placebo (Part C) | Placebo comparator | Drug: PlaceboPlacebo administered SC. |
| Placebo (Part D) | Placebo comparator | Drug: PlaceboPlacebo administered SC. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Have a body mass index (BMI) between 18.5 and 40 kilograms per square meter (kg/m²), inclusive.
- Males who agree to follow contraceptive requirements, or women not of childbearing potential (WNOCBP).
- Participants must be overtly healthy, as determined by medical evaluation.
- Participants must be first-generation Japanese, defined as the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.
- Have history of very high triglyceride (lipid) level 500 mg/dL ≤ TG <2000 mg/dL, which needs to be further confirmed at screening.
Key exclusion criteria (6 listed)
- Participants must not be currently participating in or completed a clinical trial within the last 30 days
- Have donated blood of more than 500 mL within the previous 3 months
- Have one of the following viral infections: hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV).
- Participants must not be heavy alcohol drinkers or cigarette smokers.
- For Part C: Have active pancreatitis within the last 6 months
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 |
|---|---|---|
| LY3875383Administered SC. | Drug | LY3875383 (Part A), LY3875383 (Part B), LY3875383 (Part C), LY3875383 (Part D) |
| PlaceboAdministered SC. | Drug | Placebo (Part A), Placebo (Part B), Placebo (Part C), Placebo (Part D) |
Primary outcome
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline through Week 53
A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module
4 secondary outcomes
Pharmacokinetics (PK):Area Under the Concentration Versus Time Curve (AUC) of LY3875383
Time frame: Predose up to Day 8 post dose
PK: Maximum Observed Concentration (Cmax) of LY3875383
Time frame: Predose up to Day 8 post dose
Part C and D only: Pharmacodynamics (PD): Percentage Change from Baseline in Fasting Triglyceride (TG)
Time frame: Baseline through up to Week 53
Part D only: PD: Percentage Change from Baseline in Fasting Non-High-Density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline through Week 53
Results and safety
The study was stopped early (reason given: The study was terminated due to a change in risk/benefit ratio, which no longer favoured continued development.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- A Study of LY3875383 in Healthy Participants and Participants With HypertriglyceridemiaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 LY3875383 in people with Hypertriglyceridemia, run by Eli Lilly and Company at 1 site in Singapore.
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 14 inclusion and 6 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 Jun 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 Singapore. 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?
The study was stopped early (reason given: The study was terminated due to a change in risk/benefit ratio, which no longer favoured continued development.). Results are not available in the source record.
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 Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through Week 53). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2025.