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Also known as [14C]AZD4954 Oral Solution, AZD4954 film-coated tablet, AZD4954 film-coated, [14C]AZD4954 Solution for Infusion, AZD4954 for Infusion
AZD4954 · 1 trial · 2 indications
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 |
|---|---|---|
| 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. |
| Placebo | DRUG | Placebo will be administered orally. |
Inclusion Criteria: All Parts: * Participants with plasminogen level (concentration) within normal range at the Screening Visit. * All females must have a negative pregnancy test at the Screening Visit and on admission to the study site. * Females of childbearing potential must not be lactating an...
Top 7 of 10 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Enlicitide |
| Eli Lilly and Company | LLY | 2 | PHASE3 | Lepodisiran, Muvalaplin |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE3 | Pelacarsen |
| NewAmsterdam Pharma Company N.V. | NAMS | 3 | PHASE3 | Obicetrapib |
| AstraZeneca PLC | AZN | 2 | PHASE2 | Rosuvastatin, AZD0780, AZD4954 |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE1 | ARO-DIMERPA |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX310 |
AZD4954 is an investigational small molecule being developed by AstraZeneca for dyslipidemia, a condition involving abnormal lipid levels in the blood. It is currently in Phase 1 clinical development and has not been approved by the FDA. The program includes a study enrolling healthy adults with or without elevated lipoprotein(a) levels, as well as participants with dyslipidemia.
AZD4954 is being studied for dyslipidemia, a cardiovascular condition characterized by abnormal lipid levels in the blood. It is an investigational therapy in Phase 1 development and is not approved for any indication. Clinical evaluation includes participants with dyslipidemia and healthy adults with or without elevated lipoprotein(a) levels.
AZD4954 is developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the Phase 1 clinical program evaluating the compound in dyslipidemia and in healthy participants with or without elevated lipoprotein(a) levels.
AZD4954 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA. The single registered trial is currently recruiting participants, with no completed trials reported to date.
AZD4954 is being evaluated in one Phase 1 trial, NCT06980428, titled a study to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD4954 in healthy adult participants with or without elevated lipoprotein(a) levels, and participants with dyslipidemia. The trial is recruiting, randomized, double-blind, controlled, and plans to enroll 136 participants in the United States.
Yes, those names refer to the same investigational compound. AZD4954 appears in study documentation under several labels, including [14C]AZD4954 oral solution, AZD4954 film-coated tablet, AZD4954 film-coated, [14C]AZD4954 solution for infusion, and AZD4954 for infusion. These reflect different formulations and administration forms used in the clinical program.