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Phase II Study of PG-102(MG12) Compared With Placebo in Obesity and Type 2 Diabetes

NCT06712615 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2025-07-11

No results posted yet for this study

Summary

This is a Phase 2, therapeutic exploratory study designed to evaluate the safety and efficacy of PG-102 compared with placebo. Part A includes Cohort A, comprising participants with type 2 diabetes mellitus (T2DM). Part B includes two cohorts: Cohort B1, enrolling participants with obesity, and Cohort B2, enrolling participants with both obesity and T2DM.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)
  • Obesity Type 2 Diabetes Mellitus

Interventions

BIOLOGICAL

PG-102

* Participants will receive PG-102 by subcutaneous (SC) injection. * Other Names: MG12

OTHER

Placebo

Participants will receive placebo by SC injection

Sponsors & Collaborators

  • ProGen. Co., Ltd.

    lead OTHER

Principal Investigators

  • Sin Gon Kim, MD · KOREA University Anam Hospital, Seoul, South Korea

  • Nan Hee Kim, MD · KOREA University Asan Hospital in Korea

  • Soo Lim, MD · Seoul National University Bundang Hospital in Korea

  • Seung-Hwan Lee, MD · The Catholic University of KOREA, Seoul St.Mary's Hostital in Korea

  • Yong-Ho Lee, MD · Severance Hostital in Korea

  • Hyuk-Sang Kwon, MD · The Catholic University of KOREA, Yeouido St.Mary's Hostital in Korea

  • Jang Won Son, MD · The Catholic University of KOREA, Bucheon St.Mary's Hostital in Korea

  • Sang Youl Rhee, MD · Kyung Hee University, Medical Center in Korea

  • In Kyung Jeong, MD · Kyung Hee University Hospital at Gangdong in Korea

  • Jae-Heon Kang, MD · Kangbuk Samsung Hospital, Samsung Medical Center in Korea

  • Jae Hyeon Kim, MD · Samsung Medical Center in Korea

  • Kyung Wan Min, MD · Nowon Eul Ji Medical Center, Eul Ji University in Korea

  • Jun Hwa Hong, MD · Daejeon Eul Ji Medical Center, Eul Ji University in Korea

  • Kyu Chang Won, MD · Yeungnam University Medical Center in Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-05
Primary Completion
2025-10-30
Completion
2025-10-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06712615 on ClinicalTrials.gov