Efficacy and Safety of QLG1091 vs Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT07487103
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • QLG1091 — DRUG
    Oral administration once-daily.
  • Rybelsus — DRUG
    Oral administration once-daily

Study Details

This study is to evaluate the efficacy and safety of QLG1091 vs Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes. The primary objective is to demonstrate equivalence of QLG1091 and Rybelsus. This study is a randomized, open-label, active-controlled, parallel-group, multi-center Study. The total duration of the study will be approximately 33 weeks including screening and follow-up.

Key Dates

Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
478 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: QLG1091
  • Active Comparator: Rybelsus

Primary Outcome Measure

Change in HbA1c [ Time Frame: Week 26 ]

Central Contacts

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