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A Phase Ilb, Randomized, Double-blind, Placebo ­controlled and Open-label Active Comparator Study to Evaluate the Efficacy, Safety, and Tolerability of AZD5004 in Adults with Type 2 Diabetes Mellitus

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512562-34-00
Acronym
D7261C00001
Enrollment
118
Registered
2024-11-15
Start date
2025-02-24
Completion date
2025-12-17
Last updated
2025-11-19

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

Conditions

Type 2 Diabetes Mellitus

Brief summary

Change in HbA1c from baseline to 26 weeks.

Detailed description

Change in fasting glucose from baseline to 4, 12, 16, and 26 weeks, Achieved HbA1c ≤ 6.5% at 26 weeks, Baseline HbA1c ≥ 7.0% and achieved HbA1c < 7.0% at 26 weeks, Percent change in body weight from baseline to 26 weeks, Absolute change in body weight (kg) from baseline to 26 weeks, Achievement of ≥ 5%, ≥ 10% and ≥ 15% weight reduction from baseline at Week 26

Interventions

DRUGAZD5004
DRUGRybelsus 14 mg tablets
DRUGPlacebo to match AZD5004 (PTM) film-coated tablets
DRUGRybelsus 7 mg tablets
DRUGRybelsus 3 mg tablets

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in HbA1c from baseline to 26 weeks.—

Secondary

MeasureTime frame
Change in fasting glucose from baseline to 4, 12, 16, and 26 weeks, Achieved HbA1c ≤ 6.5% at 26 weeks, Baseline HbA1c ≥ 7.0% and achieved HbA1c < 7.0% at 26 weeks, Percent change in body weight from baseline to 26 weeks, Absolute change in body weight (kg) from baseline to 26 weeks, Achievement of ≥ 5%, ≥ 10% and ≥ 15% weight reduction from baseline at Week 26—

Countries

Germany, Hungary, Poland, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026