Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07513571 | A Study to Assess the Effect of AZD0780 on the Pharmacokinetics of AZD4954 and Vice Versa in Healthy Adults | PHASE1 | RECRUITING | 32 | — | — | Apr 10, 2026 | Jul 9, 2026 | May 11, 2026 | 1 | United States |
| NCT06980428 | A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4954 in Healthy Adult Participants With or Without Elevated Lipoprotein (a) (Lp[a]) Levels, and Participants With Dyslipidemia | PHASE1 | RECRUITING | 136 | — | — | May 27, 2025 | Dec 4, 2026 | Jun 3, 2026 | 6 | United States |
To assess the effect of a single dose of oral laroprovstat on the PK of a single dose of oral AZD4954 in healthy participants.
To assess the effect of a single dose of oral laroprovstat on the PK of a single dose of oral AZD4954 in healthy participants.
To assess the effect of a single dose of oral AZD4954 on the PK of a single dose of oral laroprovstat in healthy participants.
To assess the effect of a single dose of oral AZD4954 on the PK of a single dose of oral laroprovstat in healthy participants.
To assess the safety and tolerability of AZD4954 following oral administration of SAD (Part A).
To assess the safety and tolerability of AZD4954 following oral administration of MAD (Part B).
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Treatment Sequence AC | EXPERIMENTAL | Participant will receive single dose of AZD4954 alone (Treatment A) followed by single doses of laroprovstat+AZD4954 (Treatment C). |
| Cohort 2: Treatment Sequence BC | EXPERIMENTAL | Participant will receive single dose of laroprovstat alone (Treatment B) followed by single doses of laroprovstat+AZD4954 (Treatment C). |
| Part A1: SAD Cohort 1 - AZD4954 (Dose 1) | EXPERIMENTAL | Participants will receive a single dose of AZD4954 (Dose 1) or matching placebo on Day 1. |
| Part A1: SAD Cohort 2 - AZD4954 (Dose 2) | EXPERIMENTAL | Participants will receive a single dose of AZD4954 (Dose 2) or matching placebo on Day 1. |
| Part A1: SAD Cohort 3 - AZD4954 (Dose 3) | EXPERIMENTAL | Participants will receive a single dose of AZD4954 (Dose 3) or matching placebo on Day 1. |
| Part A1: SAD Cohort 4 - AZD4954 (Dose 4) | EXPERIMENTAL | Participants will receive a single dose of AZD4954 (Dose 4) or matching placebo on Day 1. |
| Part A1: SAD Cohort 5 - AZD4954 (Dose 5) | EXPERIMENTAL | Participants will receive a single dose of AZD4954 (Dose 5) or matching placebo on Day 1. |
| Part A1: SAD Optional Cohort 6 - AZD4954 (Dose 6) | EXPERIMENTAL | Participants will receive a single dose of AZD4954 (Dose 6) or matching placebo on Day 1. This additional cohort may be added depending on the findings. |
| Part A1: SAD Cohort 1 (Japanese) - AZD4954 (Dose 2) | EXPERIMENTAL | Japanese participants will receive a single dose of AZD4954 (Dose 2) or matching placebo on Day 1. |
| Part A1: SAD Cohort 2 (Japanese) - AZD4954 (Dose 3) | EXPERIMENTAL | Japanese participants will receive a single dose of AZD4954 (Dose 3) or matching placebo on Day 1. |
| Part A1: SAD Optional Cohort 3 (Japanese) - AZD4954 | EXPERIMENTAL | This additional cohort may be added depending on the findings. |
| Part A1: SAD Cohort 1 (Chinese) - AZD4954 (Dose 5) | EXPERIMENTAL | Chinese participants will receive a single dose of AZD4954 (Dose 5) or matching placebo at the highest dose level on Day 1. |
| Part A2: SAD Food Effect Cohort - AZD4954 (Dose 2) | EXPERIMENTAL | Participants will receive a single dose of AZD4954 (Dose 2) or matching placebo with a high-calorie, high-fat breakfast on Day 1. |
| Part A2: SAD Food Effect Cohort - AZD4954 (Dose 3) | EXPERIMENTAL | Participants will receive a single dose of AZD4954 (Dose 3) or matching placebo with a high-calorie, high-fat breakfast on Day 1. |
| Part B: Global MAD Cohort 1 (healthy participants) - AZD4954 (Dose 1) | EXPERIMENTAL | Participants will receive multiple doses of AZD4954 (Dose 1) or matching placebo for 21 days. |
| Part B: Global MAD Cohort 2 (healthy participants) - AZD4954 (Dose 2) | EXPERIMENTAL | Participants will receive multiple doses of AZD4954 (Dose 2) or matching placebo for 21 days. |
| Part B: Global MAD Cohort 3 (healthy participants) - AZD4954 (Dose 3) | EXPERIMENTAL | Participants will receive multiple doses of AZD4954 (Dose 3) or matching placebo for 21 days. |
| Part B: Optional Global MAD Cohort 4 (healthy participants) - AZD4954 | EXPERIMENTAL | Participants will receive multiple doses of AZD4954 or matching placebo for 21 days. This additional cohort may be added depending on the findings. |
| Part B: MAD Cohort (Japanese) - AZD4954 (Dose 3) | EXPERIMENTAL | Japanese participants will receive multiple doses of AZD4954 (Dose 3) or matching placebo for 21 days. |
| Part B: Global MAD Cohort (participants with dyslipidemia) - AZD4954 (Dose 1) | EXPERIMENTAL | Participants with dyslipidemia will receive multiple doses of AZD4954 (Dose 1) or matching placebo for 21 days. |
| Name | Type | Description |
|---|---|---|
| AZD4954 | DRUG | AZD4954 will be administered orally. |
| Laroprovstat | DRUG | Laroprovstat will be administered orally. |
| Placebo | DRUG | Placebo will be administered orally. |
Inclusion Criteria: * All females must have a negative pregnancy test at the Screening Visit. * Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception. * Females of non-childbearing potential must b...