Phase 2 Randomized Study of PG-102 vs Placebo and Semaglutide in Type 2 Diabetes Mellitus

Sponsor
ProGen. Co., Ltd.
Study ID
NCT07187856
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

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

Interventions

  • PG-102 — DRUG
    PG-102 is administered subcutaneously once weekly with a titration regimen.
  • Placebo — DRUG
    Placebo is administered subcutaneously once weekly.
  • Semaglutide — DRUG
    Open-label semaglutide is administered subcutaneously once weekly with titration regimen.

Study Details

Phase 2 Randomized Study of PG-102 vs Placebo and Semaglutide in Type 2 Diabetes Mellitus

Key Dates

Start date
Jan 31, 2026
Status verified
Sep 2025
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: PG-102
    Participants receive PG-102 administered subcutaneously once weekly with dose titration.
  • Placebo Comparator: Placebo
    Participants receive matching placebo administered subcutaneously once weekly.
  • Active Comparator: Semaglutide
    Participants receive open-label semaglutide administered subcutaneously once weekly, titrated to 1.0 mg.

Primary Outcome Measure

Absolute change in HbA1c From Baseline at Week 24 [ Time Frame: 24 weeks ]

Central Contacts

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