A Phase III Study to Assess the Effect of AZD0780 on LDL-C in Patients With HeFH

Conditions

• Heterozygous Familial Hypercholesterolaemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• AZD0780 — DRUG
  Participants will receive daily oral dose of AZD0780
• Placebo — DRUG
  Participants will receive daily oral dose of placebo

Study Details

This is a study to evaluate the efficacy and safety of AZD0780 in adults with HeFH and elevated LDL-C, either with clinical ASCVD and LDL-C levels of 55 mg/dL or higher or without clinical ASCVD and LDL-C levels of 70 mg/dL or higher. AZD0780 is a small molecule that reduces the amount of LDL-C in the blood. Placebo will be used for comparison, and neither the participants nor the Investigators will know who is receiving the AZD0780 medication and who is receiving the placebo until the end of study. The total length of the study for an individual participant will be up to approximately 56 weeks, including a screening period of up to 14 days, treatment with AZD0780 or placebo for 52 weeks, and a safety follow-up period of 10 days.

Key Dates

Start date

Jun 10, 2025

Status verified

May 2026

Primary completion

Jan 4, 2027

Completion

Jan 4, 2027

Study Design

Enrollment

473 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: AZD0780
  Participants will receive daily oral dose of AZD0780
• Placebo Comparator: Placebo
  Participants will receive daily oral dose of placebo

Primary Outcome Measure

Relative change in LDL-C from baseline to 12 weeks [ Time Frame: Baseline - 12 weeks ]

Locations (19)

Find similar trials in Garden Grove, CA