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Active not recruitingPhase 2

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

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)

Lead sponsor

ProGen. Co., Ltd.

Asset

PG-102 / RT-114

Subcutaneous · GLP-1 / GLP-2 dual

Listed sites

14

Recruiting sites

Enrollment

144

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

HbA1c 7-10%

Primary endpoints

Glycated Hemoglobin (HbA1c) in CohortBody Weight in Cohort B1 and B2

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06712615
Org study IDPG-102-P2-01

Timeline

Milestones

Study first posted2024-12-02actual
Study start2024-12-05actual
Last update posted2025-07-11actual
Primary completion2025-10-30estimated
Study completion2025-10-30estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age19 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Adults aged 19 to 75 years who provide informed consent.

[Part A: Type 2 Diabetes Mellitus (T2DM) Specific Criteria]

2. 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.

3. Stable on metformin monotherapy or metformin in combination with one oral hypoglycemic agent for at least 90 days.

4. 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]

5. Failed at least one attempt at weight loss through diet and exercise.

6. Cohort B1: BMI ≥ 30 kg/m²

7. 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.

Exclusion criteria

1. Participation in another clinical trial within 90 days.

2. Known hypersensitivity to study drugs or their components.

3. Inability to administer the drug in the abdomen.

4. History of severe gastrointestinal disorders, recent obesity-related surgeries, or conditions affecting gastric emptying.

5. Uncontrolled severe hypertension, hypertriglyceridemia, or severe cardiovascular disease.

6. History of acute pancreatitis, recent cancer, or endocrine disorders causing obesity.

7. Abnormal lab results, including eGFR < 60 mL/min/1.73 m², AST/ALT > 3x ULN, or abnormal ECG.

8. Substance abuse or significant psychiatric disorders within the last 2 years.

9. Pregnant, breastfeeding, or unwilling to use contraception during the study.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
4
Weight & body composition
3
Safety / tolerability / PK
1

Weight & body composition

3 endpoints
Primary/protocol endpoint

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

Time frame:Baseline at weeks 14

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline at weeks 4, 8, 12, 16, and 20

percent change from baseline, improvement

Secondary/protocol endpoint

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

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

change from baseline, improvement

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

Change in Glycated Hemoglobin (HbA1c) in Cohort A

Time frame:Baseline at weeks 14

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in HbA1c in Cohort A and B2

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

change from baseline, improvement

Secondary/protocol endpoint

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

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

percent change from baseline, improvement

Secondary/protocol endpoint

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

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

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

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

Time frame:Baseline to weeks 20

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.