DelfaGLP-1 Atlas

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CompletedPhase 1

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injections of PG-102 (MG12) in Healthy Adult and Obesity Participants.

A Double-blind, Randomized, Placebo Controlled, Combined Single (Part A) and Multiple (Part B, C) Ascending Dose, Phase 1 Study to Investigate the Safety, Tolerability and Pharmacokinetic and Pharmacodynamics Following Subcutaneous Injections of PG-102(MG12) in Healthy Adult and Obesity Participants

Lead sponsor

ProGen. Co., Ltd.

Asset

PG-102 / RT-114

GLP-1 / GLP-2 dual

Listed sites

1

Recruiting sites

—

Enrollment

102

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criterion

•BMI 18-30

Primary endpoints

•Treatment-emergent adverse events (TEAEs) for Part•Treatment-emergent adverse events (TEAEs) for Part B•Serious adverse events (SAEs)

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 IDNCT06309667
Org study IDSL-MG12-P1

Timeline

Milestones

Study start2024-03-04actual
Study first posted2024-03-13actual
Primary completion2025-02-05actual
Study completion2025-02-05actual
Last update posted2025-05-06actual

Assets

Investigational agents

PG-102 / RT-114

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age19 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Eligibility criteria

1. Male or female participants, aged 18 to 65 years inclusive at the time of signing informed consent

2. Body mass index (BMI) of 18 to 30kg/m2 (inclusive) for Part A, Body mass index (BMI) of 25 to 30kg/m2 (inclusive) for Part B and Body mass index (BMI) 30 kg/m² or higher for Part C

[Exclusion Criteria]

1. History of administration of prescription drugs, herbal medicines, over-the-counter drugs, or vitamin supplements within 10 days prior to the study or history of the following drugs and/or other foods within 90 days prior to screening:

–Drugs that affect body weight (such as obesity medications, psychiatric drugs, beta blockers, diuretics, contraceptives, female hormones, proton-pump inhibitors (PPIs), H2 receptor antagonists, health functional foods/supplements, and formulas designed for weight control).
–Drugs that have the potential to impact blood sugar, liver fat, and intestinal microorganisms (including GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors, thiazolidinediones (TZDs), fish oil, polyunsaturated fatty acids (PUFA), and ursodeoxycholic acid (UDCA)), as well as individuals who are currently using insulin.

2. History of gastrointestinal diseases (Crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of clinical trial drugs.

3. History of acute proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy.

4. History of surgical treatment for obesity within 2 years (example: bariatric surgery, gastric banding etc) or gastrointestinal procedures for weight loss (including LAP-BAND®), or uncontrolled gastrointestinal disorders at Screening (e.g., peptic ulcer, gastroesophageal reflux disease).

Endpoints (18)

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.

Safety / tolerability / PK

18 endpoints
Primary/protocol endpoint

Number of participants with treatment-emergent adverse events (TEAEs) for Part A

Time frame:Baseline to Day 29

event count, event

Primary/protocol endpoint

Number of participants with treatment-emergent adverse events (TEAEs) for Part B

Time frame:Baseline to Day 57

event count, event

Primary/protocol endpoint

Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part A

Time frame:Baseline to Day 29

event count, event

Primary/protocol endpoint

Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part B

Time frame:Baseline to Day 57

event count, event

Primary/protocol endpoint

Number of participants with clinically significant abnormalities in vital signs for Part A

Time frame:Baseline to Day 29

event count, event

Primary/protocol endpoint

Number of participants with clinically significant abnormalities in vital signs for Part B

Time frame:Baseline to Day 57

event count, event

Primary/protocol endpoint

Number of participants with clinically significant abnormalities in 12-lead ECGs for Part A

Time frame:Baseline to Day 29

event count, event

Primary/protocol endpoint

Number of participants with clinically significant abnormalities in 12-lead ECGs for Part B

Time frame:Baseline to Day 57

event count, event

Secondary/protocol endpoint

Maximum plasma concentration (Cmax) for Part A

Time frame:Baseline to Day 29

concentration, descriptive

Secondary/protocol endpoint

Maximum plasma concentration (Cmax) for Part B

Time frame:Baseline to Day 57

concentration, descriptive

Secondary/protocol endpoint

Time to maximum plasma concentration (tmax) for Part A

Time frame:Baseline to Day 29

time to event, event

Secondary/protocol endpoint

Time to maximum plasma concentration (tmax) for Part B

Time frame:Baseline to Day 57

time to event, event

Secondary/protocol endpoint

Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part A

Time frame:Baseline to Day 29

concentration, descriptive

Secondary/protocol endpoint

Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part B

Time frame:Baseline to Day 57

concentration, descriptive

Secondary/protocol endpoint

Terminal half-life (t1/2) for Part A

Time frame:Baseline to Day 29

concentration, descriptive

Secondary/protocol endpoint

Terminal half-life (t1/2) for Part B

Time frame:Baseline to Day 57

concentration, descriptive

Secondary/protocol endpoint

Apparent total clearance (CL/F) for Part A

Time frame:Baseline to Day 29

concentration, descriptive

Secondary/protocol endpoint

Apparent total clearance (CL/F) for Part B

Time frame:Baseline to Day 57

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.