← Trials/Trial dossier/NCT06712615
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
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 Cohort•Body 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Weight & body composition
3 endpointsPercent Change from Baseline in Body Weight in Cohort B1 and B2
Time frame:Baseline at weeks 14
percent change from baseline, improvement
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
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 endpointsChange in Glycated Hemoglobin (HbA1c) in Cohort A
Time frame:Baseline at weeks 14
change from baseline, improvement
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
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
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 endpointIncidence 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 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.