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

Part of paid clinical trials in Glendale, California.

Sponsor
AstraZeneca
Study ID
NCT07511205
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • AZD1043 — DRUG
    Single or multiple doses of AZD1043 will be administered.
  • Placebo — OTHER
    Matching placebo to AZD1043 will be administered.

Study Details

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.

Key Dates

Start date
Mar 30, 2026
Status verified
Jun 2026
Primary completion
Apr 9, 2027
Completion
Nov 17, 2027

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A1 (Global SAD): Cohort 1 - AZD1043 (Dose 1)
    Participants will receive a single dose of AZD1043 (Dose 1) or placebo.
  • Experimental: Part A1 (Global SAD): Cohort 2 - AZD1043 (Dose 2)
    Participants will receive a single dose of AZD1043 (Dose 2) or placebo.
  • Experimental: Part A1 (Global SAD): Cohort 3 - AZD1043 (Dose 3)
    Participants will receive a single dose of AZD1043 (Dose 3) or placebo.
  • Experimental: Part A1 (Global SAD): Cohort 4 - AZD1043 (Dose 4)
    Participants will receive a single dose of AZD1043 (Dose 4) or placebo.
  • Experimental: Part A1 (Global SAD): Cohort 5 - AZD1043 (Dose 5)
    Participants will receive a single dose of AZD1043 (Dose 5) or placebo.
  • Experimental: Part A1 (Global SAD): Cohort 6 - AZD1043 (Dose 6)
    Participants will receive a single dose of AZD1043 (Dose 6) or placebo.
  • Experimental: Part A2 (Japanese SAD): Cohort 1 - AZD1043 (Dose X)
    Japanese participants will receive a single dose of AZD1043 or placebo.
  • Experimental: Part A2 (Japanese SAD): Cohort 2 - AZD1043 (Dose Y)
    Japanese participants will receive a single dose of AZD1043 or placebo.
  • Experimental: Part A3 (Chinese SAD): Cohort 1 - AZD1043 (Dose Z)
    Chinese participants will receive a single dose of AZD1043 or placebo.
  • Experimental: Part B1 (Global MAD): Cohort 1 - AZD1043 (Dose A)
    Participants will receive multiple doses of AZD1043 or placebo.
  • Experimental: Part B1 (Global MAD): Cohort 2 - AZD1043 (Dose B)
    Participants will receive multiple doses of AZD1043 or placebo.
  • Experimental: Part B1 (Global MAD): Cohort 3 - AZD1043 (Dose C)
    Participants will receive multiple doses of AZD1043 or placebo.
  • Experimental: Part B2 (Japanese MAD): Cohort 1 - AZD1043 (Dose D)
    Japanese participants will receive multiple doses of AZD1043 or placebo.

Primary Outcome Measure

Number of participants with adverse events (AEs), serious adverse events (SAEs), AE leading to discontinuation (DAEs), and AEs of special interest (AESIs) [ Time Frame: Part A (SAD): From Day-35 to Day 253; Part B (MAD): From Day 1 to Day 253 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Research SiteGlendaleCalifornia91206-
Research SiteBrooklynMaryland21225-

Find similar trials in Glendale, CA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Research Site· Glendale, CAResearch Site· Brooklyn, MD

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