RecruitingPhase 1interventionalRules rewrite

Phase 1: testing AZD1043 for Healthy Participants

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.

Official registry: https://clinicaltrials.gov/study/NCT07511205 · AstraZeneca · enrollment listed as 104

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are AZD1043, or Placebo. The registry lists allocation as randomized. 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.

They plan to enroll about 104 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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.

Interventions: AZD1043, Placebo

Primary outcome (registry wording): Number of participants with adverse events (AEs), serious adverse events (SAEs), AE leading to discontinuation (DAEs), and AEs of special interest (AESIs)

Who it is for (from inclusion criteria)

Ages 18 Years to 65 Years
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 oophorectomy, or bilateral salpingectomy
Have a body mass index between 25 and 39.9 kg/m2 (Global cohorts \[Parts A1 and B1\]), or 23 and 39.9 kg/m2 (Japanese \[Parts A2 and B2\] and Chinese \[Part A3\] cohorts) inclusive and weigh at least 50 kg
For the Part A3, participants should be Chinese defined as having both parents and 4 grandparents who are ethnically Chinese. This includes second and third generation Chinese whose parents or grandparents are living in a country other than China

Who the registry excludes

History of any clinically important disease or disorder
History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention
Any clinically important abnormalities in laboratory values, clinical chemistry, hematology, urinalysis results, or vital signs
History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs of a similar class to AZD1043
Has received prescription, non-prescription, or experimental medications for weight loss within 3 months prior to the Screening Visit
History of psychosis or bipolar disorder or major depressive disorder within the past 2 years with the participant being clinically unstable

Public study contact (from the registry)

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

3 listed

Research Site — Glendale, California (recruiting)
Research Site — Brooklyn, Maryland (recruiting)

+ 1 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07511205 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07511205?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07511205?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary