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AZD1043

Phase 1

Healthy Participants | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Aug 10, 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

Clinical trial landscape

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.
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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)

LOWAug 11, 2026NCT07511205lastUpdatePostDate: changed
LOWAug 11, 2026NCT07511205lastUpdatePostDate: changed
LOWAug 11, 2026NCT07511205lastUpdatePostDate: changed
LOWJun 10, 2026NCT07511205primaryCompletionDate: changed
LOWJun 10, 2026NCT07511205primaryCompletionDate: changed

Frequently asked questions about AZD1043

What is AZD1043 used for?

AZD1043 is an investigational small molecule being developed for metabolic conditions. It is currently in a Phase 1 clinical trial studying its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy adult participants living with overweight and/or obesity. The drug is not yet approved and remains in clinical development.

Who makes AZD1043?

AZD1043 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company is conducting a Phase 1 trial to evaluate the drug in healthy participants with overweight or obesity.

What phase is AZD1043 in?

AZD1043 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety, tolerability, and how it is processed by the body.

What clinical trials is AZD1043 in?

AZD1043 is being studied in one active Phase 1 clinical trial with the identifier NCT07511205. This randomized, double-blind, controlled study is recruiting 104 healthy adult participants with overweight or obesity in the United States and United Kingdom. The trial is investigating the drug's safety, tolerability, pharmacokinetics, and pharmacodynamics.

Is AZD1043 being studied in healthy volunteers?

Yes, AZD1043 is being studied in healthy volunteers. The Phase 1 clinical trial NCT07511205 is enrolling healthy adult participants aged 18 years and older who are living with overweight and/or obesity. The study is designed to evaluate the drug's safety, tolerability, and pharmacological effects in this population.