Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
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
Phase
Phase 3
Started
2027-01-04
Last updated
2026-11-06

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

FacilityCityRegionStatus
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
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