Assessing the safety and effects of AZD6234 in overweight or obese individuals

A 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

This study is testing the safety and effects of a new drug called AZD6234 in overweight or obese people to see how well it works compared to a placebo.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 142 (estimated)
• Ages: 18 Years to 142 Years
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Locations: 5 sites (Glendale, California and 4 other locations)
• Trial ID: NCT06132841 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug AZD6234 in healthy participants who are overweight or obese. It includes a screening period followed by a treatment phase lasting between 6 to 26 weeks, during which participants will receive either the study drug or a placebo. The study is divided into four cohorts, with participants randomized to receive different dosing regimens. A follow-up visit will occur after the last dose to assess outcomes.

Who should consider this trial

Good fit: Ideal candidates are healthy males and females aged 18 to 55 with a BMI between 25 and 40 kg/m2.

Not a fit: Patients who are not overweight or obese, or those with significant health issues, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatment options for individuals struggling with overweight and obesity.

How similar studies have performed: Other studies have shown promise with similar pharmacological approaches, but this specific drug and methodology may be novel.

Eligibility criteria

Inclusion Criteria:

* Healthy male and female participants aged 18 to 55 years with suitable veins for cannulation or repeated venipuncture.
* All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit, must not be lactating and must be of non-childbearing potential, confirmed at the Screening Visit by fulfilling one of the following criteria:

  1. Postmenopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and FSH levels in the postmenopausal range.
  2. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation.
* Have a BMI between 25 and 40 kg/m2 inclusive (at the time of screening) and weigh at least 60 kg.
* Participant must have an evaluable, pre-randomization MRI, as confirmed by the core laboratory review (Cohort 4 only).
* Cohort 4 only: Females of childbearing potential who use adequate protection (oral contraceptives are not permitted).

Exclusion Criteria:

* 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.
* Any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG as considered by the Investigator that may interfere with the interpretation of QTc interval changes, including abnormal STT wave morphology, particularly in the protocol defined primary lead or left ventricular hypertrophy.
* Known or suspected history of drug abuse, smoking, alcohol abuse or cotinine at screening.
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD6234.
* Has received prescription or non-prescription medication for weight loss within the last 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 weight loss 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 under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
* Contra-indication to MRI: such as participants with pacemakers, metallic cardiac valves, magnetic material such as surgical clips, implanted electronic infusion pumps or other conditions that would preclude proximity to a strong magnetic field; participants with history of extreme claustrophobia or participant cannot fit inside the MRI scanner cavity (Cohort 4 only).

Where this trial is running

Glendale, California and 4 other locations

• Research Site — Glendale, California, United States (Completed)
• Research Site — Brooklyn, Maryland, United States (Completed)
• Research Site — Berlin, Germany (Withdrawn)
• Research Site — Osaka-shi, Japan (Recruiting)
• Research Site — Harrow, United Kingdom (Withdrawn)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Healthy Participants; Overweight; Obesity