ARAYAZD6234 for Overweight or Obesity in Type 2 Diabetes on GLP-1 Therapy
AZD6234
+ Placebo to match
Body Weight+10
+ Diabetes Mellitus
+ Diabetes Mellitus, Type 2
Treatment Study
Summary
Study start date: March 12, 2025
Actual date on which the first participant was enrolled.This clinical trial is designed to evaluate the effectiveness, safety, and how well people can tolerate a new medication called AZD6234. It specifically targets adults between the ages of 18 and 75 who are dealing with being overweight or obese, alongside having type 2 diabetes. These participants must already be on a stable dose of a type of medication known as a GLP-1 receptor agonist. The goal is to see if AZD6234 can help improve their condition more effectively than a placebo, which is a substance with no active drug, while still being safe and well-tolerated by participants. This study could potentially offer new insights into managing weight and diabetes more effectively for this population. Participants in the study will receive weekly injections under the skin of either AZD6234 or a placebo for a certain period, while continuing their regular GLP-1 RA medication. The study is conducted at various locations in the USA and begins with a screening phase to ensure participants meet all necessary criteria. Following that, there is a treatment phase, where the participants receive the injections, and a follow-up period to monitor results. While the study aims to determine the impact of AZD6234, it will also closely monitor any side effects or adverse reactions to ensure the treatment's safety.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.64 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 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
Criteria
Inclusion Criteria: 1. Be 18 to 75 years old at the time of signing the informed consent. 2. Diagnosed with type 2 diabetes ≥ 180 days before screening. 3. HbA1c value at screening of ≥ 6.0% (42 mmol/mol) and ≤ 10% (86 mmol/mol). 4. On a stable maintenance dose of an injectable GLP-1 RA. 5. At Screening, have a BMI ≥ 27 kg/m2 Exclusion Criteria: 1. Has received treatment with prescription or non-prescription medication for weight loss within the last 3 months prior to screening (other than a GLP-1 RA). 2. Self-reported weight change of \> 5 % in the 3 months prior to screening. 3. Diabetes mellitus that is not clearly type 2 diabetes. 4. Use of insulin therapy for T2DM 5. Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier) 6. Significant hepatobiliary disease (except for non-alcoholic steatohepatitis or nonalcoholic fatty liver disease without portal hypertension or cirrhosis) 8\. Impaired renal function defined as eGFR ≤ 45 mL/minute/1.73m2 at screening
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy 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 18 locations
Research Site
Mobile, United StatesResearch Site
Doral, United StatesResearch Site
Jacksonville, United States