A Study of LY3561774 in Participants With Mixed Dyslipidemia (PROLONG-ANG3)

Lilly

Status and phase: Completed; Phase 2

Conditions: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipoproteinemia

Treatments: Drug: Placebo; Drug: LY3561774

Study type: Interventional

Funder types: Industry

Identifiers

NCT05256654

2021-005407-13 (EudraCT Number)

18361

J3F-MC-EZCB (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 205 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
  • 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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205 participants in 4 patient groups, including a placebo group

LY3561774 100 mg

Experimental group

Description:

Participants received 100 milligram (mg) LY3561774 subcutaneously (SC) on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.

Treatment:

Drug: LY3561774

LY3561774 400 mg

Experimental group

Description:

Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.

Treatment:

Drug: LY3561774

LY3561774 800 mg

Experimental group

Description:

Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.

Treatment:

Drug: LY3561774

Placebo

Placebo Comparator group

Description:

Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.

Treatment:

Drug: Placebo