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DyslipidemiasPhase 2PROLONG-ANG3NCT05256654

A Study of LY3561774 in Participants With Mixed Dyslipidemia

A Phase 2 study testing LY3561774 in people with Dyslipidemias and Lipid Metabolism Disorders, run by Eli Lilly and Company at 41 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This a multicenter, Phase 2b, double-blind, placebo-controlled, parallel group study to provide data on efficacy and safety of LY3561774 administered subcutaneously at various doses in participants with mixed dyslipidemia and on a stable dose of a statin. Read more about this study

Who is it for?
Ages 18 years and older
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
205 participants
Where
41 sitesin 7 countries
Study dates
20 Jul 2022to 23 May 2024
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have fasting triglycerides (TGs) within the range of 150 (1.69 millimole/liter (mmoL) to 499 milligram/deciliter (mg/dL) 2.26 to 5.64 millimole/liter (mmol/L) at screening.
  • Have fasting LDL-C ≥70 mg/dL (1.81 mmol/L) at screening.
  • Have non-HDL-C ≥ 130 mg/dL (3.36 mmol/L) at screening.
  • Must be on a stable moderate or high-intensity dose of a statin for at least 2 months before screening and remain on the same medication and dose for the duration of the study.
  • Have a body mass index within the range of 18.5 to 40.0 kilogram/square meter (kg/m²), inclusive

Who cannot join

  • Have in the 6 months prior to screening, uncontrolled Type 1 or Type 2 diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization, or have an hemoglobin A1c (HbA1c) ≥8% at screening.
  • Have a history of nephrotic syndrome.
  • Have a history of acute or chronic pancreatitis.
  • Have had within the past 3 months prior to screening
  • Myocardial infarction
  • Unstable angina
Show all 18Show fewer
  • Coronary artery bypass graft
  • Percutaneous coronary intervention - diagnostic angiograms are permitted
  • Peripheral artery disease
  • Transient ischemic attack, or
  • Cerebrovascular accident
  • Have New York Heart Association Class III or IV heart failure or last known left ventricular ejection fraction <30%.
  • Have undergone LDL apheresis within 12 months prior to screening.
  • Have clinically relevant anemia, as defined by the investigator.
  • Have, within 1 year prior to screening or plan on having during the study, surgical treatment for obesity.
  • Have within 3 years prior to screening a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse.
  • Have uncontrolled hypertension.
  • Have used or are taking products for the purpose of lowering lipid levels (except for statins, PCSK9 inhibitors, bempedoic acid, and ezetimibe). This includes lipid-regulating medication, over-the-counter products, or herbal therapies.

Trial locations and contacts

41 sites in 7 countries.

41 sites in 7 countries

Argentina10 sites

  • Glenny Corp

    Buenos Aires, Ciudad Aut, C1430CKE

  • Investigaciones Medicas Imoba Srl

    Buenos Aires, Ciudad Autónoma de Buenos Aire, C11056ABF

  • Fundación Respirar

    Buenos Aires, C1426ABP

  • CIPREC

    CABA, Ciudad Aut, C1061AAS

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Ciudad Autonoma de Buenos Aire, Ciudad Autónoma de Buenos Aire, C1425AGC

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aire, Buenos Air, C1027AAP

  • Clínica Privada Velez Sarsfield

    Córdoba, 5016

  • Centro de Investigaciones Clinicas Instituto del Corazon (CICIC)

    Córdoba, X5002HWE

  • Centro de Investigaciones Clinicas del Litoral

    Santa Fe, S3000FWO

  • Sanatorio San Martin

    Venado Tuerto, Santa Fe Province, 2600

Other trials in Argentina

United States6 sites

  • NECCR PrimaCare Research

    Fall River, Massachusetts, 02721

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • MD Medical Research

    Oxon Hill, Maryland, 20745

  • Premier Research

    Trenton, New Jersey, 08611

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania, 15401

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

Other trials in United States

Turkey (Türkiye)6 sites

  • Akdeniz Universitesi Hastanesi

    Antalya, 07070

  • Ege Universitesi Hastanesi

    Bornova, İzmir, 35100

  • Istanbul University Cerrahpasa Medical School Internal Diseases Institute

    Istanbul, 34096

  • Kocaeli Üniversitesi

    Kocaeli, 41380

  • Necmettin Erbakan Meram Medical Fac.

    Meram, Konya, 42080

  • Mersin University

    Mersin, 33343

Other trials in Turkey (Türkiye)

Canada5 sites

  • Ecogene-21

    Chicoutimi, Quebec, G7H 7K9

  • Viacar Recherche Clinique

    Greenfield Park, Quebec, J4V 2G8

  • OCT Research ULC

    Kelowna, British Columbia, V1Y 1Z9

  • North York Diagnostic and Cardiac Centre

    North York, Ontario, M6B 3H7

  • Clinique des Maladies Lipidiques de Québec

    Québec, Quebec, G1V 4W2

Other trials in Canada

Mexico5 sites

  • Investigacion En Salud Y Metabolismo Sc

    Chihuahua City, 31217

  • Virgen Cardiovascular Research SC

    Guadalajara, Jalisco, 44670

  • Medical Care and Research SA de CV

    Mérida, Yucatán, 97070

  • Cardiolink Clin Trials

    Monterrey, Nuevo León, 64060

  • Unidad Médica para la Salud Integral

    San Nicolás de los Garza, Nuevo León, 66465

Other trials in Mexico

Poland5 sites

  • NZOZ Centrum Medyczne KERmed

    Bydgoszcz, Kujawsko-p, 85-231

  • Centrum Badan Klinicznych PI-House sp. z o.o.

    Gdansk, Pomeranian Voivodeship, 80-546

  • Niepubliczny Zakład Opieki Zdrowotnej "Przychodnia z Sercem"

    Grojec, Lesser Poland Voivodeship, 32-615

  • Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

    Warsaw, Masovian Voivodeship, 02-097

  • Centrum Zdrowia Tuchów

    Wierzchosławice, Lesser Poland Voivodeship, 33-122

Other trials in Poland

Japan4 sites

  • Medical Corporation Chiseikai Tokyo Center Clinic

    Chuo-ku, Tokyo, 103-0028

  • AMC Nishiumeda Clinic

    Osaka, 530-0001

  • Heishinkai Medical Group ToCROM Clinic

    Shinjuku-ku, Tokyo, 160-0008

  • Medical Corporation Heishinkai OCROM Clinic

    Suita-shi, Osaka, 565-0853

Other trials in Japan

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3561774 in Adults With Mixed Dyslipidemia

This a multicenter, Phase 2b, double-blind, placebo-controlled, parallel group study to provide data on efficacy and safety of LY3561774 administered subcutaneously at various doses in participants with mixed dyslipidemia and on a stable dose of a statin.

Being tested
LY3561774, Placebo
Keywords
Triglycerides, LDL Cholesterol, Mixed Dyslipidemia
Medical subject headings
Dyslipidemias, Lipid Metabolism Disorders, Metabolic Diseases, Hyperlipoproteinemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3561774Drug

    Also called Solbinsiran

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT05256654
Study groupRoleWhat they receive
LY3561774 100 mgExperimentalParticipants received 100 milligram (mg) LY3561774 subcutaneously (SC) on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
Receives: Drug: LY3561774
LY3561774 400 mgExperimentalParticipants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
Receives: Drug: LY3561774
LY3561774 800 mgExperimentalParticipants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
Receives: Drug: LY3561774
PlaceboPlacebo comparatorParticipants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change From Baseline for Apolipoprotein B (ApoB) at Day 180

    Change in apoB levels from baseline to Day 180 expressed as a percentage of the baseline levels. Least Square Mean (LS mean) using Mixed Model for Repeated Measures (MMRM) model adjusted for baseline.

    Measured: Baseline, Day 180

Secondary outcomes (12)

  1. Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3) at Day 180

    Change in ANGPTL3 levels from baseline to Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

    Measured: Baseline, Day 180

  2. Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C) at Day 180

    Change in LDL-C levels from baseline to the day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

    Measured: Baseline, Day 180

  3. Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) at Day 180

    Change in HDL-C levels from baseline to the Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

    Measured: Baseline, Day 180

  4. Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Day 180

    Change in non-HDL-C levels from baseline to the Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

    Measured: Baseline, Day 180

  5. Percent Change From Baseline for Triglycerides at Day 180

    Change in triglycerides levels from baseline to the Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

    Measured: Baseline, Day 180

  6. Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3)

    Change in ANGPTL3 levels from baseline to Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

    Measured: Baseline, Day 270

  7. Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)

    Change in non-HDL-C levels from baseline to the Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

    Measured: Baseline, Day 270

  8. Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C)

    Change in HDL-C levels from baseline to the Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

    Measured: Baseline, Day 270

  9. Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C)

    Change in LDL-C levels from baseline to the day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

    Measured: Baseline, Day 270

  10. Percent Change From Baseline for Apolipoprotein B (ApoB)

    Change in apoB levels from baseline to Day 270 expressed as a percentage of the baseline levels. LS mean using MMRM model adjusted for baseline.

    Measured: Baseline, Day 270

  11. Percent Change From Baseline for Triglycerides

    Change in triglycerides levels from baseline to the Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

    Measured: Baseline, Day 270

  12. Pharmacokinetics (PK): Seady State Area Under the Concentration Curve From Hour 0 Extrapolated to Infinity (AUC 0-∞) of LY3561774

    PK: Seady State AUC (0-∞) of LY3561774

    Measured: On Day 0: 0.5 hour (hr) and at the latest time after 2 hr post-dose, Day 90: 24 to 48 hr postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2022
  2. Study start20 Jul 2022
  3. Primary completion4 Mar 2024
  4. Study completion23 May 2024

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05256654
Sponsor's protocol ID
18361
Other IDs
J3F-MC-EZCB, 2021-005407-13
Acronym
PROLONG-ANG3
Status last verified
Mar 2025
First submitted
23 Feb 2022
Last updated
17 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • Ray KK, Oru E, Rosenson RS, Jones J, Ma X, Walgren J, Haupt A, Verma S, Gaudet D, Nicholls SJ, Ruotolo G. Durability and efficacy of solbinsiran, a GalNAc-conjugated siRNA targeting ANGPTL3, in adults with mixed dyslipidaemia (PROLONG-ANG3): a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet. 2025 May 3;405(10489):1594-1607. doi: 10.1016/S0140-6736(25)00507-0. Epub 2025 Mar 31.

    PubMed 40179932

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY3561774 in people with Dyslipidemias and Lipid Metabolism Disorders, run by Eli Lilly and Company at 41 sites in 7 countries.

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 5 inclusion and 18 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 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in Argentina, United States, Turkey (Türkiye), Canada, Mexico and 2 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 17 Mar 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?

Percent Change From Baseline for Apolipoprotein B (ApoB) at Day 180 (time frame: Baseline, Day 180). 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 NCT05256654, 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 17 Mar 2025.

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