NCT07511205

A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1043 in Healthy Adult Participants Living With Overweight and/or Obesity

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD1043 following single and multiple ascending doses in healthy adult participants living with overweight and/or obesity, including participants of Japanese and Chinese descent.

Detailed description

This is a phase 1, first time in human (FTiH) randomized, single-blind, placebo-controlled study in healthy male and female participants living with overweight and/or obesity, with female participants being of non-childbearing potential. It consists of 2 parts: Part A (single ascending doses: SAD): This will consist of Part A1 (Global SAD (GSAD)) with 6 cohorts, Part A2 (Japanese SAD (JSAD)) with 2 cohorts and Part A3 (Chinese SAD (CSAD)) with 1 cohort. Part B (multiple ascending doses: MAD): This will consist of Part B1 (Global MAD (GMAD)) with 3 cohorts and Part B2 (Japanese MAD (JMAD)) with 1 cohort. Participants are only allowed to participate in one of the cohorts. Both Part A and Part B will comprise of: * Screening period (up to 5 weeks). * Treatment period. * Safety follow-up period.

Conditions

• Healthy Participants
• Obesity

Interventions

Type	Name	Description
DRUG	AZD1043	Single or multiple doses of AZD1043 will be administered.
OTHER	Placebo	Matching placebo to AZD1043 will be administered.

Timeline

• Start date: 2026-03-30
• Primary completion: 2027-03-15
• Completion: 2027-10-21
• First posted: 2026-04-06
• Last updated: 2026-04-13

Locations

2 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study