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AZD1043

Phase 1

Obesity | Small molecule | Metabolic |AstraZeneca PLC|Trials Updated: Oct 13, 2026

AZD1043 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment104

FDA Designations

No designations recorded

AZD1043 clinical trials

AZD1043 · 1 trial · 2 indications

Phase 1 1
NCT07511205A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1043 in Healthy Adult Participants Living With Overweight and/or Obesity.Healthy Participants
RECRUITING104 Analytics
PHASE1RECRUITING
A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1043 in Healthy Adult Participants Living With Overweight and/or Obesity.
Healthy ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

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

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.

Secondary Endpoints

Area under concentration-time curve from time 0 to infinity (AUCinf) (Part A only)
From Day 1 to Day 253
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
From Day 1 to Day 253
Maximum observed drug concentration (Cmax)
From Day 1 to Day 253
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

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

Interventions

NameTypeDescription
AZD1043DRUGSingle or multiple doses of AZD1043 will be administered.
PlaceboOTHERMatching placebo to AZD1043 will be administered.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites3

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...

Countries:United StatesUnited Kingdom
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Recent Changes (Last 90 Days)

LOWOct 13, 2026NCT07511205lastUpdatePostDate: changed
LOWOct 13, 2026NCT07511205lastUpdatePostDate: changed
LOWSep 9, 2026NCT07511205lastUpdatePostDate: changed
LOWSep 9, 2026NCT07511205lastUpdatePostDate: changed
LOWAug 11, 2026NCT07511205lastUpdatePostDate: changed
LOWAug 11, 2026NCT07511205lastUpdatePostDate: changed
LOWAug 11, 2026NCT07511205lastUpdatePostDate: changed

Frequently asked questions about AZD1043

What is AZD1043?

AZD1043 is an investigational small molecule being developed by AstraZeneca PLC for obesity. It is in Phase 1 clinical development and has not been approved by any regulatory agency. The program sits within AstraZeneca's metabolic therapeutic area and is currently being evaluated in a single recruiting study.

What is AZD1043 used for?

AZD1043 is being studied for obesity, including in adults living with overweight and/or obesity. It is an investigational therapy, so it is not yet available as a treatment outside of clinical trials. Its development focuses on the metabolic therapeutic area.

Who makes AZD1043?

AZD1043 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating the compound in obesity. The drug remains investigational and is not commercially available.

What phase is AZD1043 in?

AZD1043 is in Phase 1 clinical development. It has one active, recruiting trial and no completed trials. As a Phase 1 asset, it is investigational and has not received FDA approval. The program is being run in adults with overweight and/or obesity.

What clinical trials is AZD1043 in?

AZD1043 is being evaluated in the Phase 1 trial NCT07511205, titled a study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of AZD1043 in healthy adult participants living with overweight and/or obesity. The trial is recruiting, is randomized, double-blind, and controlled, with planned enrollment of 104 participants across the United States and United Kingdom.

What does AZD1043 target?

AZD1043 is a small molecule, but its specific molecular target has not been disclosed. It is being developed for obesity within AstraZeneca's metabolic portfolio. The Phase 1 trial NCT07511205 is designed to assess safety, tolerability, pharmacokinetics and pharmacodynamics in adults with overweight and/or obesity.