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

NCT06132841 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: D8750C00002
• Study Type: interventional
• Target: 104
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Healthy Participants

Keywords

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• Number of participants with Adverse Events (AEs) and Serious Adverse Events(SAE)

  The safety and tolerability of repeated subcutaneous (SC) doses of AZD6234 compared to placebo will be assessed.

  From Screening (Day -35 to Day -3) to Day 78 (Cohort 1) or to Day 120 (Cohort 2 and 3) or to Day 225 (Cohort 4)

Secondary Outcomes (11)

• Maximum observed plasma drug concentration (Cmax)

  From Day 1 to Day 78 (Cohort 1) or to Day 120 (Cohort 2 and 3) or to Day 225 (Cohort 4)

• Area under the plasma concentration-time (AUClast)

  From Day 1 to Day 78 (Cohort 1) or to Day 120 (Cohort 2 and 3) or to Day 225 (Cohort 4)

• Area under plasma concentration-time curve from zero to infinity (AUCinf)

  From Day 1 to Day 78 (Cohort 1) or to Day 120 (Cohort 2 and 3) or Day 225 (Cohort 4)

• Area under concentration time curve in the dosing interval (AUCtau)

  From Day 1 to Day 78 (Cohort 1) or to Day 120 (Cohort 2 and 3) or to Day 225 (Cohort 4)

• Change from baseline in body weight of participants

  From baseline (Day -1) to Day 43 (Cohort 1) or to Day 85 (Cohort 2 and 3) or to Day 183 (Cohort 4)

Study Arms (4)

Cohort 1

EXPERIMENTAL

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

Drug: AZD6234; Drug: Placebo

Cohort 2

EXPERIMENTAL

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

Drug: AZD6234; Drug: Placebo

Cohort 3

EXPERIMENTAL

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

Drug: AZD6234; Drug: Placebo

Cohort 4

EXPERIMENTAL

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

Drug: AZD6234; Drug: Placebo

Interventions

Placebo DRUG

Participants will receive matching volumes of the placebo as a solution via SC

Cohort 1; Cohort 2; Cohort 3; Cohort 4

AZD6234 DRUG

Participants will receive repeated doses of AZD6234 as a solution via SC

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years - 142 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (3)

Research Site

Glendale, California, 91206, United States

Location

Research Site

Brooklyn, Maryland, 21225, United States

Location

Research Site

Osaka, 532-0003, Japan

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 15, 2023
• Study Start: November 13, 2023
• Primary Completion: March 4, 2026
• Study Completion: March 23, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

JP (1); US (2)