Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD2693 · 5 trials · 6 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
Safety and tolerability of AZD2693 compared to placebo following multiple dose SC administration in healthy participants will be evaluated.
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: AZD2693 | EXPERIMENTAL | Japanese Participants will receive Dose A of AZD2693. |
| Cohort 2: AZD2693 | EXPERIMENTAL | Japanese Participants will receive Dose B of AZD2693. |
| Cohort 3: AZD2693 | EXPERIMENTAL | Japanese Participants will receive Dose C of AZD2693. |
| Cohort 4: AZD2693 | EXPERIMENTAL | Non-Asian Participants will receive Dose C of AZD2693 |
| 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 nonalcoholic steatohepatitis (NASH), hepatic impairment, metabolic disorders, and in healthy participants. It is in Phase 1 clinical development and is not approved by the FDA. Studies have assessed its safety, tolerability, and pharmacokinetics in various populations.
AZD2693 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is currently in Phase 1 clinical trials, with studies conducted in the United States and Japan.
AZD2693 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. All four clinical trials for AZD2693 have been completed, with a total enrollment of 220 participants across studies in the United States and Japan.
AZD2693 has completed four Phase 1 clinical trials. These include NCT04142424 in overweight healthy subjects and healthy Chinese and Japanese subjects, NCT04483947 in NASH patients, NCT05107336 in healthy Japanese participants, and NCT05919069 in participants with hepatic impairment. All trials were completed in the United States or Japan.
AZD2693 is the only name provided for this drug. No alternative names or aliases have been reported for this investigational compound. It is being studied under this identifier in clinical trials registered with ClinicalTrials.gov.
The mechanism of action for AZD2693 has not been specified in available information. It is classified as a small molecule therapeutic being investigated for metabolic disorders and nonalcoholic steatohepatitis. Clinical trials have focused on evaluating its safety, tolerability, and pharmacokinetics rather than its molecular target.