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HS-20094 vs Dulaglutide in T2D Uncontrolled on Metformin +/- SGLT2i
NCT07156539Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Sep 2025
- Primary completion
- Mar 2027
- Countries
- 1
- Sponsor
- Hansoh Pharmaceutical Group
- Modality
- Peptides
- Drugs
- olatorepatide
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 3, randomised trial of olatorepatide in type 2 diabetes mellitus (T2DM) (3 arms), sponsored by Hansoh Pharmaceutical Group. Primary endpoint: Change in Glycated Hemoglobin (HbA1c) at 44 weeks. Planned start Sep 2025; status: not yet recruiting.
02
Design
3 arms- Study design
- Randomized
HS-20094 Low Dose
HS-20094 Injection (Low Dose) QW + Background Metformin +/- SGLT2i
HS-20094 High Dose
HS-20094 Injection (High Dose) QW + Background Metformin +/- SGLT2i
Dulaglutide
Dulaglutide 1.5mg Injection QW + Background Metformin +/- SGLT2i
03
Endpoints
Primary
Change in Glycated Hemoglobin (HbA1c)
Secondary
Proportion of subjects with HbA1c < 7.0%
Proportion of subjects with HbA1c <= 6.5%
Change in Fasting Plasma Glucose
Change in body weight
Proportion of subjects with weight loss >= 5%
Proportion of subjects with weight loss >= 10%
Change in Glycated Hemoglobin (HbA1c) at Week 52
Incidence and severity of adverse events
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