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Type 2 Diabetes Mellitus (T2DM)Phase 2NCT06712615

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

A Phase 2 study testing PG-102 in people with Type 2 Diabetes Mellitus (T2DM) and Obesity Type 2 Diabetes Mellitus, run by ProGen. Co., Ltd. at 14 sites in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 19 to 75 years
What is being tested?
PG-102
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
144 participants
Where
14 sitesSouth Korea
Study dates
5 Dec 2024to 30 Oct 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 19 to 75 years who provide informed consent.
  • [Part A: Type 2 Diabetes Mellitus (T2DM) Specific Criteria]
  • Diagnosed with type 2 diabetes for at least 6 months, with HbA1c between 7.0% and 10.0%, despite adherence to diet and exercise therapy according to diabetes treatment guidelines.
  • Stable on metformin monotherapy or metformin in combination with one oral hypoglycemic agent for at least 90 days.
  • BMI between 18.5 kg/m² and 30.0 kg/m², with a minimum weight of 55 kg for men and 50 kg for women.
  • [Part B: Obesity (OB) Specific Criteria]
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  • Failed at least one attempt at weight loss through diet and exercise.
  • Cohort B1: BMI ≥ 30 kg/m²
  • Cohort B2: BMI ≥ 27 kg/m² 8-1. Cohort B2: Diagnosed with type 2 diabetes for at least 6 months, with HbA1c between 7.0% and 10.0%.
  • 8-2. Cohort B2: Received treatment with diet and exercise alone, OR stable on approved oral antidiabetic monotherapy or combination therapy for at least 90 days prior to screening.

Who cannot join

  • Participation in another clinical trial within 90 days.
  • Known hypersensitivity to study drugs or their components.
  • Inability to administer the drug in the abdomen.
  • History of severe gastrointestinal disorders, recent obesity-related surgeries, or conditions affecting gastric emptying.
  • Uncontrolled severe hypertension, hypertriglyceridemia, or severe cardiovascular disease.
  • History of acute pancreatitis, recent cancer, or endocrine disorders causing obesity.
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  • Abnormal lab results, including eGFR < 60 mL/min/1.73 m², AST/ALT > 3x ULN, or abnormal ECG.
  • Substance abuse or significant psychiatric disorders within the last 2 years.
  • Pregnant, breastfeeding, or unwilling to use contraception during the study.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

South Korea14 sites

  • The Catholic University of KOREA, Bucheon St.Mary's Hostital

    Bucheon-si

  • Yeungnam University Medical Center

    Daegu

  • Daejeon Eul Ji Medical Center, Eul Ji University

    Daejeon

  • Seoul National University Bundang Hospital

    Seongnam

  • Kangbuk Samsung Hospital, Samsung Medical Center

    Seoul

  • KOREA University Anam Hospital

    Seoul

  • KOREA University Asan Hospital

    Seoul

  • Kyung Hee University Hospital at Gangdong

    Seoul

  • Kyung Hee University, Medical Center

    Seoul

  • Nowon Eul Ji Medical Center, Eul Ji University

    Seoul

  • Samsung Medical Center

    Seoul

  • Severance Hostital

    Seoul

  • The Catholic University of KOREA, Seoul St.Mary's Hostital

    Seoul

  • The Catholic University of KOREA, Yeouido St.Mary's Hostital in Korea

    Seoul

Other trials in South Korea

About this study

Official title: A Phase II Randomized, Double-blind, Multi-center Study to Investigate the Efficacy and Safety of PG-102(MG12) Compared With Placebo in Subjects With Obesity and in Subjects With Type 2 Diabetes Mellitus (T2DM)

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.

Being tested
PG-102, Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PG-102Biological

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

  • PlaceboOther

    Participants will receive placebo by SC injection

Study groups in NCT06712615
Study groupRoleWhat they receive
Cohort AExperimentalCohort A will include two sub-cohorts with different dosing schedules in participants diagnosed with type 2 diabetes.
Receives: Biological: PG-102
Cohort B1ExperimentalCohort B1 will include two sub-cohorts with different dosing schedules in participants with obesity.
Receives: Biological: PG-102
Cohort B2ExperimentalCohort B2 will include two sub-cohorts with different dosing schedules in participants with obesity and type 2 diabetes.
Receives: Biological: PG-102
Cohort A (Placebo)Placebo comparatorCohort A will include two sub-cohorts with different dosing schedules in participants diagnosed with type 2 diabetes.
Receives: Other: Placebo
Cohort B1 (Placebo)Placebo comparatorCohort B1 will include two sub-cohorts with different dosing schedules in participants with obesity.
Receives: Other: Placebo
Cohort B2 (Placebo)Placebo comparatorCohort B2 will include two sub-cohorts with different dosing schedules in participants with obesity and type 2 diabetes.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Glycated Hemoglobin (HbA1c) in Cohort A

    Measured: Baseline at weeks 14

  2. Percent Change from Baseline in Body Weight in Cohort B1 and B2

    Measured: Baseline at weeks 14

Secondary outcomes (6)

  1. Incidence of Treatment-emergent adverse events (TEAEs) in Cohort A and Cohort B1, B2

    Measured: Baseline to weeks 20

  2. Change from Baseline in HbA1c in Cohort A and B2

    Measured: Baseline at weeks 4, 8, 12, 14, 16, and 20

  3. Percent Change from Baseline in fasting plasma glucose (FPG) in Cohort A and B2

    Measured: Baseline at weeks 4, 8, 12, 14, 16, and 20

  4. Absolute Change from Baseline in fasting plasma glucose in Cohort A and B2

    Measured: Baseline, Week 4, 8, 12, 14, 16, and 20 weeks

  5. Percent Change from Baseline in Body Weight in Cohort B1 and B2

    Measured: Baseline at weeks 4, 8, 12, 16, and 20

  6. Absolute Change from Baseline in Body Weight in Cohort B1 and B2

    Measured: Baseline at weeks 4, 8, 12, 14, 16, and 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2024
  2. Study start5 Dec 2024
  3. Primary completion30 Oct 2025 (estimated)
  4. Study completion30 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06712615
Sponsor's protocol ID
PG-102-P2-01
Status last verified
Jul 2025
First submitted
26 Nov 2024
Last updated
11 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PG-102 in people with Type 2 Diabetes Mellitus (T2DM) and Obesity Type 2 Diabetes Mellitus, run by ProGen. Co., Ltd. at 14 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycated Hemoglobin (HbA1c) in Cohort A (time frame: Baseline at weeks 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06712615.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.

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