Clinical Trials in India / NCT07922330
Starting soon
Phase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
NCT07922330 · tracked via the Priya Life Science India tracker
Condition(s) studied
ObesityOverweightType 2 Diabetes Mellitus
Investigational drug(s) / intervention(s)
AZD6234 →Placebo
AZD6234: administered once weekly.
Placebo: Matching placebo administered once weekly.
Study summary
This study will evaluate the efficacy and safety of AZD6234 compared with placebo in adults who are overweight or obese, with or without type 2 diabetes mellitus.
Eligibility
Inclusion Criteria:
* Aged 18 years or older at the time of signing informed consent.
* Body mass index:
* at least 28 kg/m²; or
* at least 24 kg/m² and less than 28 kg/m² with at least one protocol-defined weight-related comorbidity, including type 2 diabetes mellitus, hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction-associated steatotic liver disease, knee osteoarthritis, or stress urinary incontinence.
* Stable body weight (≤ 5% body weight change) for at least 3 months prior to Randomisation.
* Participants with type 2 diabetes mellitus must:
* have been diagnosed at least 6 months before informed consent;
* have HbA1c between 6.0% and 10.0% at Screening; and
* be managed with diet and exercise alone or with a stable dose of 1 to 3 oral glucose-lowering medications for at least 3 months before Screening.
* At least one previous self-reported unsuccessful attempt to lose body weight.
* Participants of childbearing potential must comply with protocol-defined highly effective contraception requirements and have negative pregnancy tests at Screening and Randomisation.
* Able to provide signed informed consent.
Exclusion Criteria:
* Obesity primarily caused by another endocrine disorder.
* Severe heart failure, defined as New York Heart Association Class IV, or hospitalisation for heart failure within 3 months before Screening.
* Type 1 diabetes mellitus or ketoacidosis or hyperosmolar coma/state within 3 months before Screening.
* Clinically significant gastric-emptying abnormality requiring treatment.
* Significant inflammatory bowel disease or another severe disease or prior surgery affecting the upper gastrointestinal tract.
* Cardiovascular event, percutaneous coronary intervention, or coronary artery bypass graft within 3 months before Screening.
* Previous or planned surgical treatment for obesity.
* Uncontrolled hypothyroidism or hyperthyroidism.
* Significant hepatobiliary disease, including protocol-defined elevations in alanine aminotransferase, aspartate aminotransferase, or total bilirubin.
* Neoplastic disease within 5 years before Screening, except as otherwise permitted by the protocol.
* Clinically important disease or disorder that may place the participant at risk or interfere with study participation.
* Known or suspected drug abuse or alcohol abuse.
* Planned elective surgery requiring discontinuation of study intervention for more than 6 weeks.
* Weight-management treatment within 3 months before Randomisation.
* Treatment with a glucagon-like peptide-1 receptor agonist or another glucagon-like peptide-1-containing medication within 3 months before Randomisation.
* Treatment with a marketed or investigational amylin-based compound within 3 months before Randomisation.
* Use of insulin therapy for type 2 diabetes mellitus.
* Long-term systemic glucocorticoid treatment lasting more than 14 days or use of central nervous system stimulants.
* Concomitant medication that may increase risk, affect study results, or interfere with study participation.
* Unstable major depressive disorder or Patient Health Questionnaire-9 score of 15 or higher.
* History of psychosis or active symptomatic bipolar disorder.
* Active suicidal ideation corresponding to Category 4 or 5 on the Columbia-Suicide Severity Rating Scale, or history of a suicide attempt.
* Participation in another clinical study within 30 days before Screening.
* Known hypersensitivity to AZD6234.
* Involvement in the planning and/or conduct of the study.
* Unlikely or unable to comply with study procedures, restrictions, or requirements.
* Previous randomisation in the present study.
* Currently pregnant or breastfeeding.
* Any other condition that, in the Investigator's judgement, makes participation inappropriate.
Primary outcome measure(s)
- Percent change in body weight from baseline at Week 64 — up to 64 weeks
To evaluate the effect of AZD6234 as compared to placebo in percent body weight change from baseline of treatment. - Number of participants achieving at Least a 5% Reduction in Body Weight From Baseline at Week 64 — up to 64 weeks
To evaluate the effect of AZD6234 as compared to placebo in body weight loss of at least 5% from baseline of treatment.
Trial sites (34)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Beijing | China | |
| Research Site | Bozhou | China | |
| Research Site | Cangzhou | China | |
| Research Site | Changzhou | China | |
| Research Site | Chongqing | China | |
| Research Site | Daqing | China | |
| Research Site | Ganzhou | China | |
| Research Site | Guangzhou | China | |
| Research Site | Guangzhou | China | |
| Research Site | Jiaxing | China | |
| Research Site | Jinan | China | |
| Research Site | Jinan | China | |
| Research Site | Liuzhou | China | |
| Research Site | Luoyang | China | |
| Research Site | Luzhou | China | |
| Research Site | Sanya | China | |
| Research Site | Shanghai | China | |
| Research Site | Shanghai | China | |
| Research Site | Shanghai | China | |
| Research Site | Shenyang | China | |
| Research Site | Shenyang | China | |
| Research Site | Shiyan | China | |
| Research Site | Suzhou | China | |
| Research Site | Wuhan | China | |
| Research Site | Xi'an | China | |
| Research Site | Xuancheng | China | |
| Research Site | Yuncheng | China | |
| Research Site | Zhengzhou | China | |
| Research Site | Ansārinagar | India | |
| Research Site | Calicut | India | |
| Research Site | Kolkata | India | |
| Research Site | Ludhiana | India | |
| Research Site | Meerut | India | |
| Research Site | Surat | India |
More AstraZeneca trials in India
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Active, not recruiting
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07922330 on ClinicalTrials.gov ↗ ← All trials in India