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NCT06834932

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of AZD0780 in Participants With Dyslipidaemia

StatusActive, Not Recruiting
PhasePhase 2/3
Primary completion (estimated)

At risk: Primary completion moved at least 1 year 7 months later.

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Record History

All 13 versions: 12 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jul 3, 2025 to Feb 22, 2027
    • Eligibility criteria expanded, about 35 words
    • Study sites: 42 to 40
    • Secondary endpoints: details revised at 2 of 8 entries
  2. Primary completion moved earlier from Feb 22, 2027 to Jul 3, 2025
    • Study sites: 43 to 42
    v12
  3. Trial status changed: Recruiting → Active, Not Recruiting
    • Enrollment increased: 360 → 432 participants
    • Site details revised at 43 of 43 sites
    v11
  4. Site details revised at 3 of 43 sitesv10
  5. Enrollment target: 380 to 360
    • Primary and study completion dates: Jun 28, 2027 to Feb 22, 2027
    • Site details revised at 1 of 43 sites
    v9
Show 6 earlier versionsHide 6 earlier versions
  1. Enrollment target: 360 to 380
    • Primary and study completion dates: Jun 18, 2027 to Jun 28, 2027
    • Site details revised at 8 of 43 sites
    v8
  2. Enrollment target: 300 to 360
    • Study sites: 40 to 43
    v7
  3. Site details revised at 1 of 40 sitesv5
  4. Eligibility criteria expanded, about 214 wordsv4 Show 4 more changesShow less
    • Primary endpoints revised (5)
    • Study sites: 24 to 40
    • Secondary endpoints revised (8)
    • Study description expanded, about 2 words
  5. Study sites: 18 to 24v3
  6. Enrollment target: 60 to 300
    • Primary and study completion dates: Jun 26, 2025 to Jun 18, 2027
    • Study sites: 11 to 18
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

AZD0780 Concentrations in plasma (PART A)
Timeframe: Day 1 and Day 8: Pre-dose, 0.25,0.5,1,1.5,2,3,4,6,8,12,16 hours post-dose. Day 2, Day 9, Day 11, Day 15, Day 22, Day 29: Pre-dose (PART A)
AZD0780 PK Parameter: AUC0-t (PART A, intensive PK subgroup).
Timeframe: Day 1 and Day 8: Pre-dose, 0.25,0.5,1,1.5,2,3,4,6,8,12,16 hours post-dose. Day 2, Day 9, Day 11, Day 15, Day 22, Day 29: Pre-dose (PART A)
AZD0780 PK parameter: Cmax (PART A, intensive PK subgroup)
Timeframe: Day 1 and Day 8: Pre-dose, 0.25,0.5,1,1.5,2,3,4,6,8,12,16 hours post-dose. Day 2, Day 9, Day 11, Day 15, Day 22, Day 29: Pre-dose (PART A)
AZD0780 PK parameter: AUCtau (PART A, intensive PK sub group)
Timeframe: Day 1 and Day 8: Pre-dose, 0.25,0.5,1,1.5,2,3,4,6,8,12,16 hours post-dose. Day 2, Day 9, Day 11, Day 15, Day 22, Day 29: Pre-dose (PART A)
Relative change in LDL-C from baseline to 12 weeks (PART B)
Timeframe: From baseline to 12 weeks (PART B)

Secondary (8)

Relative change from baseline of LDL-C at Week 4 (PART A)
Relative change in LDL-C from baseline to 12 weeks (PART B Cohort 2)
Relative change in LDL-C from baseline to 12 weeks (PART B)
Indicator for LDL-C < 70 mg/dL (< 1.8 mmol/L) at 12 weeks (PART B)
Indicator for LDL-C < 55 mg/dL (< 1.4 mmol/L) at 12 weeks (PART B)
Show 3 moreShow less
Relative change in LDL-C from baseline to 28 weeks (PART B cohort 1)
Relative change in LDL-C from baseline to 52 weeks (PART B cohort 1)
Relative change in lipid panel from baseline to 12 weeks (PART B cohort 2)

Arms and interventions

AZD0780 +Rosuvastatin Dose 1 (Part A)Experimental

* Participants will receive Rosuvastatin Dose 1 QD for minimum 21 days (up to 28 days) * Then receive AZD0780 QD as add on for next 28 days (Part A)

Placebo +Rosuvastatin Dose 1 (Part A)Placebo comparator

* Participants will receive Rosuvastatin Dose 1 QD for minimum 21 days (up to 28 days) * Then receive Placebo QD as add on for next 28 days (Part A)

AZD0780 +Rosuvastatin Dose 2 (Part A)Experimental

* Participants will receive Rosuvastatin Dose 2 QD for minimum 21 days (up to 28 days) * Then receive AZD0780 QD as add on for next for 28 days (Part A)

Placebo + Rosuvastatin Dose 2 (Part A)Placebo comparator

* Participants will receive Rosuvastatin Dose 2 QD for minimum 21 days (up to 28 days) * Then receive Placebo QD as add on for 28 days (Part A)

AZD0780 (Part B Cohort 1)Experimental

• Participate will receive AZD0780 QD for 52 weeks (Part B Cohort 1)

Placebo (Part B Cohort 1)Placebo comparator

• Participate will receive Placebo QD for 52 weeks (Part B Cohort 1)

AZD0780+Rosuvastatin Dose 1 (Part B Cohort 2)Experimental

* Participate receive Rosuvastatin Dose 1 for 28 days. * Then receive AZD0780 QD as add on for 12 weeks (Part B Cohort 2)

Placebo+Rosuvastation Dose 1 (Part B Cohort 2)Placebo comparator

* Participate receive Rosuvastatin Dose 1 for 28 days. * Then receive Placebo QD as add on for 12 weeks (Part B Cohort 2)

Drugs: Placebo, Rosuvastatin Dose 1, Rosuvastatin dose 2, AZD0780

Sites

40 sites in 2 countries

China 39, Hong Kong 1