Share
Save
A Study in Participants With Obesity or Overweight With at Least One Weight-related Comorbidity
A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD6234 compared with placebo, given once a week as subcutaneous injection for 36 weeks, in male and female participants of at least 18 years of age who are living with obesity (body mass index \[BMI\] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) and at least one weight-related comorbidity.
Study details:
The study will comprise of:. A screening period of maximum 28 days. A treatment period of 36 weeks.
A follow up period after last dose of study drug. This study will consist of 4 cohorts. Approximately 231 eligible participants will be randomized to AZD6234 or placebo.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-10-01
Primary completion: 2025-10-14
Study completion finish: 2026-02-18
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT06595238
Intervention or treatment
DRUG: AZD6234
DRUG: Placebo comparator
Conditions
- • Obesity or Overweight
Find a site
Closest Location:
Research Site
Research sites nearby
Select from list below to view details:
Research Site
Heidelberg West, Not Specified, Australia
Research Site
Maroochydore, Not Specified, Australia
Research Site
Maroubra, Not Specified, Australia
Research Site
Merewether, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Arm 1
| DRUG: AZD6234
|
EXPERIMENTAL: Arm 2
| DRUG: AZD6234
|
EXPERIMENTAL: Arm 3
| DRUG: AZD6234
|
PLACEBO_COMPARATOR: Arm 4
| DRUG: Placebo comparator
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Percent change in body weight from baseline to week 26 | To determine whether AZD6234 is superior to placebo for weight loss | 26 weeks |
| Weight loss ≥ 5% from baseline weight to week 26 | To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 5% from baseline | 26 weeks |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Weight loss ≥ 5% from baseline to week 36 | To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 5% from baseline | 36 weeks |
| Weight loss ≥ 10% from baseline to week 36 | To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 10% from baseline | 36 weeks |
| Percent change in body weight from baseline to week 36 | To determine whether AZD6234 is superior to placebo for weight loss | 36 weeks |
| Absolute change in body weight (kg) from baseline to week 26 and week 36 | To determine whether AZD6234 is superior to placebo for absolute weight loss | week 26 and week 36 |
| AZD6234 plasma concentrations | To characterise the PK of AZD6234 | Week 43 |
Frequently Asked Questions
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!