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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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524616-11-00
Enrollment
195
Registered
2026-10-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity or overweight Diabetes Mellitus, Type 2

Brief summary

Percent change from baseline in body weight at 68 weeks of treatment

Detailed description

Absolute change in weight from baseline at 68 weeks of treatment, Achievement of at least 5% body weight loss from baseline at 68 weeks of treatment, Achievement of at least 10% body weight loss from baseline at 68 weeks of treatment, Percent change from baseline in body weight at 68 weeks of treatment, Change in haemoglobin A1C from baseline at 68 weeks of treatment, Change in waist circumference from baseline at 68 weeks of treatment, Percent change in triglycerides from baseline at 68 weeks of treatment, Change in systolic blood pressure from baseline at 68 weeks of treatment, Changes in PRO score from baseline at 68 weeks of treatment, Percent change in fat mass from baseline at 68 weeks of treatment measured by DXA, Occurrence and time to first occurrence of AE, SAE, SAE with outcome death, AE leading to discontinuation of investigational intervention, AE leading to interruption of investigational intervention, other action taken related to investigational intervention, possibly related AE as assessed by investigator, possibly related SAE as assessed by investigator, Observed laboratory values change from baseline and time to first treatment emergent abnormality, Observed vital sign value (including systolic and diastolic blood pressure, pulse rate), change from baseline, and time to first treatment emergent abnormality, Observed ECG parameter, change from baseline, and time to first treatment emergent abnormality, Observed changes in DXA body composition from baseline, in a subset of participants

Interventions

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percent change from baseline in body weight at 68 weeks of treatment—

Secondary

MeasureTime frame
Absolute change in weight from baseline at 68 weeks of treatment, Achievement of at least 5% body weight loss from baseline at 68 weeks of treatment, Achievement of at least 10% body weight loss from baseline at 68 weeks of treatment, Percent change from baseline in body weight at 68 weeks of treatment, Change in haemoglobin A1C from baseline at 68 weeks of treatment, Change in waist circumference from baseline at 68 weeks of treatment, Percent change in triglycerides from baseline at 68 weeks of treatment, Change in systolic blood pressure from baseline at 68 weeks of treatment, Changes in PRO score from baseline at 68 weeks of treatment, Percent change in fat mass from baseline at 68 weeks of treatment measured by DXA, Occurrence and time to first occurrence of AE, SAE, SAE with outcome death, AE leading to discontinuation of investigational intervention, AE leading to interruption of investigational intervention, other action taken related to investigational intervention, possibly r—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 7, 2026