Phase II Study of Switching From Dulaglutide to PG-102(MG12) in Type 2 Diabetes Mellitus

Sponsor
ProGen. Co., Ltd.
Study ID
NCT07677891
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • PG-102(MG12) — DRUG
    GLP-1 and GLP-2 fusion protein
  • Dulaglutide — DRUG
    GLP-1 receptor agonist

Study Details

This is a randomized, open-label, multi-center, active-controlled Phase 2 clinical trial to evaluate the efficacy and safety of switching from once-weekly dulaglutide to PG-102(MG12) in patients with type 2 diabetes mellitus receiving stable dulaglutide therapy. The treatment period is 32 weeks, with an additional 4-week safety follow-up. The primary endpoint is the change in HbA1c(%) from baseline at Week 32.

Key Dates

First listed
Jul 1, 2026
Start date
Oct 31, 2026
Status verified
Jun 2026
Primary completion
May 31, 2027
Completion
Jun 30, 2027

Study Design

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

Arms

  • Experimental: PG-102(MG12) 60mg
    PG-102(MG12) 60 mg (N=20). Subcutaneous Injection with dose titration: Once weekly for 4 weeks, once every 2 weeks for 4 weeks, then once every 4 weeks for 24 weeks
  • Experimental: PG-102(MG12) 90mg
    PG-102(MG12) 90 mg (N=20). Subcutaneous Injection with dose titration: Once weekly for 4 weeks, once every 2 weeks for 4 weeks, then once every 4 weeks for 24 weeks
  • Active Comparator: Dulaglutide
    Continued dulaglutide at current maintenance dose (N=20). Subcutaneous injection once weekly per label

Primary Outcome Measure

Change in HbA1c from Baseline at Week 32 [ Time Frame: [Time Frame: Baseline to Week 32] ]

Central Contacts

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