Suspended

AZD6234 Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Evaluation in Overweight or Obese Participants

Study Aim

This study aims to evaluate the safety and tolerability of repeated subcutaneous doses of AZD6234, by observing the number of adverse events and serious adverse events in overweight or obese participants.

What is being tested

AZD6234

+ Placebo

Drug

Who is being recruted

Body Weight+5

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

From 18 to 142 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: November 2023

See protocol details

Summary

Principal SponsorAstraZeneca

Last updated: February 10, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: November 13, 2023

Actual date on which the first participant was enrolled.

This clinical trial is designed to test a new medication called AZD6234, which is intended to help individuals who are overweight or have obesity. The main goal is to determine if AZD6234 is safe and well-tolerated when taken repeatedly over time. Researchers are also interested in understanding how the body processes the drug and how the drug affects the body, which could provide valuable insights into potential treatments for weight management. This study is important because it addresses the growing need for safe and effective treatments for obesity, a condition linked to various health issues. Participants in this study will go through a screening process to ensure they are eligible. They will then be placed into one of four groups, known as cohorts, and receive either the drug AZD6234 or a placebo, which is a substance with no active drug, to compare effects. The treatment will be administered during a residential stay at a clinical unit for different durations depending on the cohort. The study includes a follow-up visit after the last dose to monitor any long-term effects. The researchers will be closely observing for any potential risks and monitoring how the drug is absorbed and used by the body during this period.

Official TitleA Phase I Randomized, Single-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD6234 Following Repeat Dose Administration in Participants With Overweight or Obesity

NCT06132841

Principal SponsorAstraZeneca

Last updated: February 10, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

104 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 142 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

Criteria

2 inclusion criteria required to participate

Females of childbearing potential who use adequate protection (oral contraceptives are not permitted).

Have a BMI between 25 and 40 kg/m2 inclusive (at the time of screening) and weigh at least 60 kg.

7 exclusion criteria prevent from participating

History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.

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 IMP.

Participants who follow vegan diet or have medical dietary restrictions.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants will receive repeated doses of AZD6234 or placebo via SC injection

Group II

Experimental

Participants will receive repeated doses of AZD6234 or placebo via SC injection

Group III

Experimental

Japanese participants will receive repeated doses of AZD6234 or placebo via SC injection

Group IV

Experimental

Japanese participants with childbearing potential will receive repeated doses of AZD6234 or placebo via SC injection.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Research Site

Glendale, United StatesOpen Research Site in Google Maps

Suspended

Research Site

Brooklyn, United States

Suspended

Research Site

Osaka, Japan

Suspended3 Study Centers