Study identifier:D9740C00001
ClinicalTrials.gov identifier:NCT07511205
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD1043 Following Single and Multiple Ascending Doses via Subcutaneous and/or Intravenous Administration in Healthy Adult Participants Living with Overweight and/or Obesity
Healthy Participants, obesity
Phase 1
Yes
AZD1043
All
104
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Apr 2026 by AstraZeneca
AstraZeneca
PAREXEL
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Part A1 (Global SAD): Cohort 1 - AZD1043 (Dose 1) Participants will receive a single dose of AZD1043 (Dose 1) or placebo. | Drug: AZD1043 Single or multiple doses of AZD1043 will be administered. Other: Placebo Matching placebo to AZD1043 will be administered. |
| Experimental: Part A1 (Global SAD): Cohort 2 - AZD1043 (Dose 2) Participants will receive a single dose of AZD1043 (Dose 2) or placebo. | Drug: AZD1043 Single or multiple doses of AZD1043 will be administered. Other: Placebo Matching placebo to AZD1043 will be administered. |
| Experimental: Part A1 (Global SAD): Cohort 3 - AZD1043 (Dose 3) Participants will receive a single dose of AZD1043 (Dose 3) or placebo. | Drug: AZD1043 Single or multiple doses of AZD1043 will be administered. Other: Placebo Matching placebo to AZD1043 will be administered. |
| Experimental: Part A1 (Global SAD): Cohort 4 - AZD1043 (Dose 4) Participants will receive a single dose of AZD1043 (Dose 4) or placebo. | Drug: AZD1043 Single or multiple doses of AZD1043 will be administered. Other: Placebo Matching placebo to AZD1043 will be administered. |
| Experimental: Part A1 (Global SAD): Cohort 5 - AZD1043 (Dose 5) Participants will receive a single dose of AZD1043 (Dose 5) or placebo. | Drug: AZD1043 Single or multiple doses of AZD1043 will be administered. Other: Placebo Matching placebo to AZD1043 will be administered. |
| Experimental: Part A1 (Global SAD): Cohort 6 - AZD1043 (Dose 6) Participants will receive a single dose of AZD1043 (Dose 6) or placebo. | Drug: AZD1043 Single or multiple doses of AZD1043 will be administered. Other: Placebo Matching placebo to AZD1043 will be administered. |
| Experimental: Part A2 (Japanese SAD): Cohort 1 - AZD1043 (Dose X) Japanese participants will receive a single dose of AZD1043 or placebo. | Drug: AZD1043 Single or multiple doses of AZD1043 will be administered. Other: Placebo Matching placebo to AZD1043 will be administered. |
| Experimental: Part A2 (Japanese SAD): Cohort 2 - AZD1043 (Dose Y) Japanese participants will receive a single dose of AZD1043 or placebo. | Drug: AZD1043 Single or multiple doses of AZD1043 will be administered. Other: Placebo Matching placebo to AZD1043 will be administered. |
| Experimental: Part A3 (Chinese SAD): Cohort 1 - AZD1043 (Dose Z) Chinese participants will receive a single dose of AZD1043 or placebo. | Drug: AZD1043 Single or multiple doses of AZD1043 will be administered. Other: Placebo Matching placebo to AZD1043 will be administered. |
| Experimental: Part B1 (Global MAD): Cohort 1 - AZD1043 (Dose A) Participants will receive multiple doses of AZD1043 or placebo. | Drug: AZD1043 Single or multiple doses of AZD1043 will be administered. Other: Placebo Matching placebo to AZD1043 will be administered. |
| Experimental: Part B1 (Global MAD): Cohort 2 - AZD1043 (Dose B) Participants will receive multiple doses of AZD1043 or placebo. | Drug: AZD1043 Single or multiple doses of AZD1043 will be administered. Other: Placebo Matching placebo to AZD1043 will be administered. |
| Experimental: Part B1 (Global MAD): Cohort 3 - AZD1043 (Dose C) Participants will receive multiple doses of AZD1043 or placebo. | Drug: AZD1043 Single or multiple doses of AZD1043 will be administered. Other: Placebo Matching placebo to AZD1043 will be administered. |
| Experimental: Part B2 (Japanese MAD): Cohort 1 - AZD1043 (Dose D) Japanese participants will receive multiple doses of AZD1043 or placebo. | Drug: AZD1043 Single or multiple doses of AZD1043 will be administered. Other: Placebo Matching placebo to AZD1043 will be administered. |