A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD6234 After Repeat Dose Administration in Participants Who Are Overweight or Obese

Last updated: April 17, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

1

Condition

Obesity

Hypertriglyceridemia

Treatment

AZD6234

Placebo

Clinical Study ID

NCT06132841
D8750C00002
  • Ages 18-142
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

A study in healthy male and female participants of non-childbearing and childbearing potential who have overweight or obesity

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy male and female participants aged 18 to 55 years with suitable veins forcannulation or repeated venipuncture.

  • All females must have a negative pregnancy test at the Screening Visit and onadmission to the Clinical Unit, must not be lactating and must be ofnon-childbearing potential, confirmed at the Screening Visit by fulfilling one ofthe following criteria:

  1. Postmenopausal defined as amenorrhea for at least 12 months or more followingcessation of all exogenous hormonal treatments and FSH levels in thepostmenopausal range.

  2. Documentation of irreversible surgical sterilization by hysterectomy, bilateraloophorectomy, or bilateral salpingectomy but not tubal ligation.

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

  • Participant must have an evaluable, pre-randomization MRI, as confirmed by the corelaboratory review (Cohort 4 only).

  • Cohort 4 only: Females of childbearing potential who use adequate protection (oralcontraceptives are not permitted).

Exclusion

Exclusion Criteria:

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

  • History or presence of gastrointestinal, hepatic or renal disease, or any othercondition known to interfere with absorption, distribution, metabolism, or excretionof drugs.

  • Any clinically important illness, medical/surgical procedure or trauma within 4weeks of the first administration of IMP.

  • Any clinically important abnormalities in rhythm, conduction or morphology of theresting ECG and any clinically important abnormalities in the 12-lead ECG asconsidered by the Investigator that may interfere with the interpretation of QTcinterval changes, including abnormal STT wave morphology, particularly in theprotocol defined primary lead or left ventricular hypertrophy.

  • Known or suspected history of drug abuse, smoking, alcohol abuse or cotinine atscreening.

  • History of severe allergy/hypersensitivity or ongoing clinically importantallergy/hypersensitivity, as judged by the Investigator or history ofhypersensitivity to drugs with a similar chemical structure or class to AZD6234.

  • Has received prescription or non-prescription medication for weight loss within thelast 3 months.

  • Self-reported weight change of > 5 kg in the last 3 months prior to screening.

  • Previous or planned (within study period) bariatric surgery or fitting of a weightloss device (eg, gastric balloon or duodenal barrier).

  • Participants who follow vegan diet or have medical dietary restrictions.

  • Participants who cannot communicate reliably with the Investigator.

  • Vulnerable participants, e.g., kept in detention, protected adults underguardianship, trusteeship, or committed to an institution by governmental orjuridical order.

  • Contra-indication to MRI: such as participants with pacemakers, metallic cardiacvalves, magnetic material such as surgical clips, implanted electronic infusionpumps or other conditions that would preclude proximity to a strong magnetic field;participants with history of extreme claustrophobia or participant cannot fit insidethe MRI scanner cavity (Cohort 4 only).

Study Design

Total Participants: 142
Treatment Group(s): 2
Primary Treatment: AZD6234
Phase: 1
Study Start date:
November 13, 2023
Estimated Completion Date:
February 04, 2026

Study Description

The study will comprise of:

  • A Screening Period of maximum 32 days (from Day -35 to Day -3).

  • A Treatment Period of 6 weeks (Cohort 1), 12 weeks (Cohort 2 and 3) and 26 weeks (Cohort 4) during which the participants will receive the study drug during residency at clinical unit.

  • A Follow-up Visit after the last dose of study drug.

This study with repeated dosing of AZD6234 consists of 4 cohorts. For cohorts 1,2 and 3, eligible participants will be randomized to AZD6234 and placebo in a 3:1 ratio. For Cohort 4, eligible participants will be randomized in a 4:1:4:1 ratio.

Connect with a study center

  • Research Site

    Berlin, 14050
    Germany

    Site Not Available

  • Research Site

    Osaka-shi, 532-0003
    Japan

    Active - Recruiting

  • Research Site

    Harrow, HA1 3UJ
    United Kingdom

    Site Not Available

  • Research Site

    Glendale, California 91206
    United States

    Completed

  • Research Site

    Brooklyn, Maryland 21225
    United States

    Completed

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