Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD2693 · 4 trials · 5 indications
To assess the effect of AZD2693 versus placebo on histological resolution of NASH in participants with non-cirrhotic NASH with fibrosis and PNPLA3 risk allele carriers after 52 weeks
area under the concentration-time curve (AUC) from zero to infinity (AUCinf)
area under the concentration-time curve from time zero to last time of quantifiable concentration
maximum observed plasma concentration
To investigate the safety and tolerability of SC administration of SAD of AZD2693
| Arm | Type | Description |
|---|---|---|
| AZD2693 dose 1 | EXPERIMENTAL | Participants will receive AZD2693 dose 1 |
| AZD2693 dose 2 | EXPERIMENTAL | Participants will receive AZD2693 dose 2 |
| Placebo | PLACEBO_COMPARATOR | Participants in this arm will receive placebo |
| Group 1 | EXPERIMENTAL | Participants with mild hepatic impairment (CP Class A, score of 5 or 6) |
| Group 2 | EXPERIMENTAL | Participants with moderate hepatic impairment (CP Class B, score of 7 to 9) |
| Group 3 | EXPERIMENTAL | Participants with severe hepatic impairment (CP Class C, score of 10 to 15) |
| Group 4 | EXPERIMENTAL | Participants with normal hepatic function matched on a group level regarding age, body weight, and sex to the impaired groups |
| Cohort 1 | EXPERIMENTAL | 15 participants will receive AZD2693 dose 1 and 5 participants will receive placebo |
| Cohort 2 | EXPERIMENTAL | 15 participants will receive AZD2693 dose 2 and 5 participants will receive placebo |
| Cohort 3 | EXPERIMENTAL | 15 participants will receive AZD2693 dose 1 and 5 participants will receive placebo |
| Cohort 4 | EXPERIMENTAL | 15 participants will receive AZD2693 dose 3 and 5 participants will receive placebo |
| Cohort 1 healthy subjects: AZD2693 Dose 1 | EXPERIMENTAL | Subjects will receive a subcutaneous (SC) injection of single dose 1 of AZD2693 or placebo matched to AZD2693 on Day 1. |
| Cohort 2 healthy subjects: AZD2693 Dose 2 | EXPERIMENTAL | Subjects will receive a SC injection of single dose 2 of AZD2693 or placebo matched to AZD2693 on Day 1. |
| Cohort 3 healthy subjects: AZD2693 Dose 3 | EXPERIMENTAL | Subjects will receive a SC injection of single dose 3 of AZD2693 or placebo matched to AZD2693 on Day 1. |
| Cohort 4 healthy subjects: AZD2693 Dose 4 | EXPERIMENTAL | Subjects will receive a SC injection of single dose 4 of AZD2693 or placebo matched to AZD2693 on Day 1. |
| Cohort 5 healthy subjects: AZD2693 Dose 5 | EXPERIMENTAL | Subjects will receive a SC injection of single dose 5 of AZD2693 or placebo matched to AZD2693 on Day 1. |
| Cohort 6 healthy subjects: AZD2693 Dose 6 | EXPERIMENTAL | Subjects will receive a SC injection of single dose 6 of AZD2693 or placebo matched to AZD2693 on Day 1. |
| Cohort 7 healthy Japanese subjects: AZD2693 Dose 7 | EXPERIMENTAL | Subjects will receive a SC injection of single dose 7 of AZD2693 or placebo matched to AZD2693 on Day 1. |
| Cohort 8 healthy Japanese subjects: AZD2693 Dose 8 | EXPERIMENTAL | Subjects will receive a SC injection of single dose 8 of AZD2693 or placebo matched to AZD2693 on Day 1. |
| Cohort 9 healthy Chinese subjects: AZD2693 Dose 9 | EXPERIMENTAL | Subjects will receive a SC injection of single dose 9 of AZD2693 or placebo matched to AZD2693 on Day 1. |
| Name | Type | Description |
|---|---|---|
| AZD2693 | DRUG | AZD2693 solution SC once per month |
| Placebo | OTHER | Sodium chloride 0.9% solution SC once per month |
Key Inclusion Criteria : Participants are eligible to be included in the study only if all the following criteria apply: Age 1. Participant must be 18 to 75 years of age (inclusive) at the time of signing the informed consent. Type of Participant and Disease Characteristics 2. Participants wh...
AZD2693 is an investigational small molecule being studied for non-alcoholic steatohepatitis (NASH), also called nonalcoholic steatohepatitis, and related metabolic disorders. Clinical trials have evaluated it in participants with non-cirrhotic NASH with fibrosis who carry the PNPLA3 148M risk allele, as well as in hepatic impairment and in overweight but otherwise healthy volunteers.
AZD2693 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca sponsors the clinical program, including the Phase 1 and Phase 2 studies that have evaluated the compound in hepatic impairment, metabolic disorders, and non-alcoholic steatohepatitis.
AZD2693 has completed Phase 1 and Phase 2 clinical trials. The Phase 2 study, NCT05809934, evaluated AZD2693 in 220 participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis who are carriers of the PNPLA3 148M risk allele. The drug remains investigational and has not been approved for any indication.
AZD2693 has been studied in four completed trials: NCT05919069, a Phase 1 hepatic impairment study with 35 participants; NCT05809934, a Phase 2 NASH study with 220 participants; NCT04483947, a Phase 1 NASH study with 74 participants; and NCT04142424, a Phase 1 study in healthy volunteers with 73 participants.
No, AZD2693 is not FDA approved. It is an investigational small molecule that has completed Phase 1 and Phase 2 clinical development for non-alcoholic steatohepatitis and related metabolic disorders. AstraZeneca continues to evaluate the compound in clinical research.