NCT07784270RecruitingPhase 3
A Phase III Randomized, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants With Type 2 Diabetes Mellitus and Obesity or Overweight (SELENE 2)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- AstraZeneca
- Enrollment
- 1,500
- Locations
- 227
- Primary Endpoint
- Percent change in body weight from baseline at 68 weeks of treatment.
Study Overview
Brief Summary
The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment
Detailed Description
This is a Phase III, global, randomized, parallel-group, double-blind, multicentre study to assess the efficacy and safety of AZD6234 compared with placebo in adults with Type 2 Diabetes Mellitus (T2DM) and obesity or overweight. Eligible participants will be randomized to either receive AZD6234 or matching placebo respectively.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males & females (inclusive of all gender identities) age ≥18 years
- •BMI ≥27 kg/m2
- •Diagnosed with T2DM ≥90 days prior to Screening
- •HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤10% (86 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent (as per local labelling)
- •Stable body weight (≤5% body weight change) for at least 3 months prior to Randomisation
- •History of at least one self-reported unsuccessful attempt to lose body weight in lifetime
Exclusion Criteria
- •Obesity primarily caused by other endocrine disorders
- •Type 1 diabetes mellitus (or any other diabetes mellitus that is not clearly Type 2 diabetes), OR have history of ketoacidosis or hyperosmolar coma/state within 3 months prior to Screening
- •Significant hepatobiliary disease and/or any of the following results at Screening:
- •ALT ≥ 3.0 X ULN
- •AST ≥ 3.0 X ULN
- •TBL > 1.5 X ULN (except for cases of known Gilbert's Syndrome)
- •Has received treatment with a GLP-1 receptor agonist or GLP-1 containing medication for any indication within 3 months before Randomisation
- •Use of insulin therapy for T2DM within 3 months prior to screening
Arms & Interventions
Placebo
Placebo Comparator
Matching placebo
Intervention: Placebo (Drug)
AZD6234 Dose 2
Experimental
AZD6234 Dose 2
Intervention: AZD6234 (Drug)
AZD6234 Dose 1
Experimental
AZD6234 Dose 1
Intervention: AZD6234 (Drug)
Outcomes
Primary Outcomes
Percent change in body weight from baseline at 68 weeks of treatment.
Time Frame: 68 weeks
To evaluate the effect of AZD6234 compared to placebo in percent body weight change
Secondary Outcomes
- Absolute change in weight (kg) from baseline at 68 weeks of treatment(68 weeks)
- Achievement of at least 5 % body weight loss from baseline at 68 weeks of treatment(68 weeks)
- Achievement of at least 10 % body weight loss from baseline at 68 weeks of treatment(68 weeks)
- Change in haemoglobin A1C from baseline at 68 weeks of treatment(68 weeks)
- Change in waist circumference (cm) from baseline at 68 weeks of treatment(68 weeks)
- Percent change in triglycerides from baseline at 68 weeks of treatment(68 weeks)
- Change in systolic blood pressure (mmHg) from baseline at 68 weeks of treatment(68 weeks)
- Percent change in fat mass from baseline at 68 weeks of treatment measured by DXA in the DXA Sub-Study subset(68 weeks)
Investigators
Study Sites (227)
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