DyslipidemiasPhase 1NCT04644809
A Study of LY3561774 in Participants With Dyslipidemia
A Phase 1 study testing LY3561774 in people with Dyslipidemias, run by Eli Lilly and Company at 5 sites in United States.
Trial summary
This is a 3-part study. In Parts A and B, the main purpose is to evaluate the safety and tolerability of the study drug known as LY3561774 in participants with dyslipidemia (high blood fat levels). How the body processes the study drug and the effect of the study drug on blood fat levels will also be investigated. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- LY3561774
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Nov 2020to 17 May 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For Parts A and B, have a fasting triglyceride (TG) level greater than or equal to (≥) 150 milligram/deciliter (mg/dL) and less than 500 mg/dL, as well as low density lipoprotein cholesterol (LDL-C) level greater than or equal to (≥) 70 mg/dL
- For Part C, participants should be first-generation Japanese origin.
- Have a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m²)
- Male participants must agree to adhere to contraception restrictions and female participants must not be able to get pregnant
Who cannot join
- Have taken any prescription medications that are for lowering serum TGs within the past 2 months (use of statins is allowed if the dose has been stable for 8 weeks)
- Have Type 1 diabetes
- Are currently participating in or completed a clinical trial within the last 30 days
- Are heavy alcohol drinkers or heavy cigarette smokers
- Have donated blood of more than 500 millilitres (mL) in the last 3 months
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Altasciences Clinical Los Angeles, Inc
Cypress, California, 90630
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37920
Collaborative Neuroscience Research, LLC
Long Beach, California, 90806
Hassman Research Institute
Marlton, New Jersey, 08053
Qps-Mra, Llc
South Miami, Florida, 33143
About this study
Official title: A Single-Ascending and Repeat-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3561774
This is a 3-part study. In Parts A and B, the main purpose is to evaluate the safety and tolerability of the study drug known as LY3561774 in participants with dyslipidemia (high blood fat levels). How the body processes the study drug and the effect of the study drug on blood fat levels will also be investigated. Part C will mainly evaluate the safety and tolerability of LY3561774 as well as how the body processes the study drug in Japanese participants. The study may last up 52, 56 and 28 weeks for each participant in Parts A, B and C, respectively. There are up to 22, 26 and 16 visits in Parts A, B and C, respectively.
- Conditions
- Dyslipidemias
- Being tested
- LY3561774, Placebo
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3561774Drug
Administered SC.
PlaceboDrug
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| LY3561774 (Part A) | Experimental | Single ascending doses of LY3561774 administered subcutaneously (SC). Receives: Drug: LY3561774 |
| LY3561774 (Part B) | Experimental | Repeat doses of LY3561774 administered SC. Receives: Drug: LY3561774 |
| LY3561774 (Part C) | Experimental | Single doses of LY3561774 administered SC in Japanese Participants. Receives: Drug: LY3561774 |
| Placebo (Part A, B & C) | 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 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
Measured: Baseline up to Week 53
Secondary outcomes (4)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3561774
PK: AUC[0-tlast] of LY3561774
Measured: Predose through Day 8
PK: Maximum Observed Drug Concentration (Cmax) of LY3561774
PK: Cmax of LY3561774
Measured: Predose through Day 8
PK: Time of Maximum Observed Concentration (Tmax) of LY3561774
PK: Tmax of LY3561774
Measured: Predose through Day 8
PD: Change From Baseline in Fasting Triglyceride (TG) and low-density lipoprotein cholesterol (LDL-C)
PD: Change From Baseline in Fasting TG and LDL-C
Measured: Predose 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 posted25 Nov 2020
- Study start30 Nov 2020
- Primary completion17 May 2022
- Study completion17 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiasStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 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
- NCT04644809
- Sponsor's protocol ID
- 17825
- Other IDs
- J3F-MC-EZCA
- Status last verified
- 1 Aug 2022
- First submitted
- 24 Nov 2020
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ray KK, Linnebjerg H, Michael LF, Shen X, Ma X, Lim S, Zhen EY, Dudek H, Abrams M, Saxena U, Turanov A, Nicholls SJ, Ruotolo G. Effect of ANGPTL3 Inhibition With Solbinsiran in Preclinical and Early Human Studies. J Am Coll Cardiol. 2025 May 20;85(19):1803-1818. doi: 10.1016/j.jacc.2025.03.005. Epub 2025 Mar 30.
PubMed 40158211
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Ascending and Repeat-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3561774
- ClinicalTrials.gov ID
- NCT04644809
- Acronym / sponsor ID
- 17825
- Conditions
- Dyslipidemias
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 25 Nov 2020 (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.
This is a 3-part study. In Parts A and B, the main purpose is to evaluate the safety and tolerability of the study drug known as LY3561774 in participants with dyslipidemia (high blood fat levels). How the body processes the study drug and the effect of the study drug on blood fat levels will also be investigated. Part C will mainly evaluate the safety and tolerability of LY3561774 as well as how the body processes the study drug in Japanese participants. The study may last up 52, 56 and 28 weeks for each participant in Parts A, B and C, respectively. There are up to 22, 26 and 16 visits in Parts A, B and C, respectively.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LY3561774 (Part A) | Experimental | Drug: LY3561774Single ascending doses of LY3561774 administered subcutaneously (SC). |
| LY3561774 (Part B) | Experimental | Drug: LY3561774Repeat doses of LY3561774 administered SC. |
| LY3561774 (Part C) | Experimental | Drug: LY3561774Single doses of LY3561774 administered SC in Japanese Participants. |
| Placebo (Part A, B & C) | Placebo comparator | Drug: PlaceboPlacebo administered SC. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- For Parts A and B, have a fasting triglyceride (TG) level greater than or equal to (≥) 150 milligram/deciliter (mg/dL) and less than 500 mg/dL, as well as low density lipoprotein cholesterol (LDL-C) level greater than or equal to (≥) 70 mg/dL
- For Part C, participants should be first-generation Japanese origin.
- Have a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m²)
- Male participants must agree to adhere to contraception restrictions and female participants must not be able to get pregnant
Key exclusion criteria (5 listed)
- Have taken any prescription medications that are for lowering serum TGs within the past 2 months (use of statins is allowed if the dose has been stable for 8 weeks)
- Have Type 1 diabetes
- Are currently participating in or completed a clinical trial within the last 30 days
- Are heavy alcohol drinkers or heavy cigarette smokers
- Have donated blood of more than 500 millilitres (mL) in the last 3 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 |
|---|---|---|
| LY3561774Administered SC. | Drug | LY3561774 (Part A), LY3561774 (Part B), LY3561774 (Part C) |
| PlaceboAdministered SC. | Drug | Placebo (Part A, B & C) |
Primary outcome
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 up to Week 53
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
4 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3561774
Time frame: Predose through Day 8
PK: Maximum Observed Drug Concentration (Cmax) of LY3561774
Time frame: Predose through Day 8
PK: Time of Maximum Observed Concentration (Tmax) of LY3561774
Time frame: Predose through Day 8
PD: Change From Baseline in Fasting Triglyceride (TG) and low-density lipoprotein cholesterol (LDL-C)
Time frame: Predose through Week 53
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Derived from this study: PubMed 40158211Ray KK, Linnebjerg H, Michael LF, Shen X, Ma X, Lim S, Zhen EY, Dudek H, Abrams M, Saxena U, Turanov A, Nicholls SJ, Ruotolo G. Effect of ANGPTL3 Inhibition With Solbinsiran in Preclinical and Early Human Studies. J Am Coll Cardiol. 2025 May 20;85(19):1803-1818. doi: 10.1016/j.jacc.2025.03.005. Epub 2025 Mar 30.
- A Study of LY3561774 in Participants With DyslipidemiaLink 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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3561774 in people with Dyslipidemias, run by Eli Lilly and Company at 5 sites 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline up to Week 53). 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 NCT04644809, 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 10 Aug 2022.