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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07511205 | A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1043 in Healthy Adult Participants Living With Overweight and/or Obesity. | PHASE1 | RECRUITING | 104 | — | — | Mar 30, 2026 | Oct 21, 2027 | Apr 27, 2026 | 2 | United States, United Kingdom |
To assess the safety and tolerability of a single or multiple doses of AZD1043 in healthy adult participants living with overweight and/or obesity, including participants of Japanese and Chinese descent.
| Arm | Type | Description |
|---|---|---|
| Part A1 (Global SAD): Cohort 1 - AZD1043 (Dose 1) | EXPERIMENTAL | Participants will receive a single dose of AZD1043 (Dose 1) or placebo. |
| Part A1 (Global SAD): Cohort 2 - AZD1043 (Dose 2) | EXPERIMENTAL | Participants will receive a single dose of AZD1043 (Dose 2) or placebo. |
| Part A1 (Global SAD): Cohort 3 - AZD1043 (Dose 3) | EXPERIMENTAL | Participants will receive a single dose of AZD1043 (Dose 3) or placebo. |
| Part A1 (Global SAD): Cohort 4 - AZD1043 (Dose 4) | EXPERIMENTAL | Participants will receive a single dose of AZD1043 (Dose 4) or placebo. |
| Part A1 (Global SAD): Cohort 5 - AZD1043 (Dose 5) | EXPERIMENTAL | Participants will receive a single dose of AZD1043 (Dose 5) or placebo. |
| Part A1 (Global SAD): Cohort 6 - AZD1043 (Dose 6) | EXPERIMENTAL | Participants will receive a single dose of AZD1043 (Dose 6) or placebo. |
| Part A2 (Japanese SAD): Cohort 1 - AZD1043 (Dose X) | EXPERIMENTAL | Japanese participants will receive a single dose of AZD1043 or placebo. |
| Part A2 (Japanese SAD): Cohort 2 - AZD1043 (Dose Y) | EXPERIMENTAL | Japanese participants will receive a single dose of AZD1043 or placebo. |
| Part A3 (Chinese SAD): Cohort 1 - AZD1043 (Dose Z) | EXPERIMENTAL | Chinese participants will receive a single dose of AZD1043 or placebo. |
| Part B1 (Global MAD): Cohort 1 - AZD1043 (Dose A) | EXPERIMENTAL | Participants will receive multiple doses of AZD1043 or placebo. |
| Part B1 (Global MAD): Cohort 2 - AZD1043 (Dose B) | EXPERIMENTAL | Participants will receive multiple doses of AZD1043 or placebo. |
| Part B1 (Global MAD): Cohort 3 - AZD1043 (Dose C) | EXPERIMENTAL | Participants will receive multiple doses of AZD1043 or placebo. |
| Part B2 (Japanese MAD): Cohort 1 - AZD1043 (Dose D) | EXPERIMENTAL | Japanese participants will receive multiple doses of AZD1043 or placebo. |
| Name | Type | Description |
|---|---|---|
| AZD1043 | DRUG | Single or multiple doses of AZD1043 will be administered. |
| Placebo | OTHER | Matching placebo to AZD1043 will be administered. |
Inclusion Criteria: * All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit. * Females of non-childbearing potential must be confirmed as postmenopausal or have documentation of irreversible surgical sterilization by hysterectomy, bilateral oop...