DelfaGLP-1 Atlas

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Not yet recruitingPhase 2

Phase 2 Randomized Study of PG-102 vs Placebo and Semaglutide in Type 2 Diabetes Mellitus

A Phase 2 Randomised Controlled Study to Investigate the Efficacy and Safety of Subcutaneously Administered PG-102 for 24 Weeks Compared With Placebo and Open-Label Semaglutide in Patients With Type 2 Diabetes Mellitus

Lead sponsor

ProGen. Co., Ltd.

Assets

PG-102 / RT-114 / Semaglutide

Listed sites

1

Recruiting sites

—

Enrollment

80

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 25-40•HbA1c 7-10%

Primary endpoint

•HbA1c, change

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 IDNCT07187856
Org study IDPG-102-P2-WW-01

Timeline

Milestones

Study first posted2025-09-23actual
Last update posted2025-09-23actual
Study start2026-01estimated (month precision)
Primary completion2026-09estimated (month precision)
Study completion2026-12estimated (month precision)

Assets

Investigational agents

PG-102 / RT-114Semaglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
•Adult males and females, 18 to 75 years of age (inclusive) on the day of signing the informed consent form (ICF).
•Must have a diagnosis of T2DM for at least 6 months before screening based on the disease diagnostic criteria.
•Must have an HbA1c value at screening of ≥7.0% and ≤10.0% (≥53 and ≤86 mmol/mol) and treated with diet and exercise alone or a stable dose of metformin (either immediate release or extended release, ≥1000 mg/day and not more than the locally approved dose) for at least 3 months prior to screening.
•Body mass index (BMI) ≥25 to <40 kg/m2 at screening.

Exclusion criteria

•Have a diagnosis of type 1 diabetes.
•History of severe hypoglycaemia and/or hypoglycaemia unawareness within 6 months prior to screening.
•Have active proliferative diabetic retinopathy or history of uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
•History of or current chronic pancreatitis, or acute pancreatitis within the past 6 months prior to screening.
•Diagnosis of gastroparesis or history of bariatric surgery or a clinically significant gastric emptying abnormality, in the opinion of the investigator (or delegate).
•Have known liver disease or obvious clinical signs or symptoms of liver disease, including acute or chronic hepatitis; or have any of the following at screening: ALT ≥ 3 × ULN, AST ≥ 3 × ULN, and total bilirubin ≥2 × ULN.
•Concomitant therapy in addition to metformin therapy with another oral antihyperglycaemic medication (OAM) including, but not limited to, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose cotransport 2 inhibitors, alpha-glucosidase inhibitors, and meglitinides. Participants may be randomised if the additional OAM was discontinued at least 3 months prior to screening.
•Have used insulin for diabetic control within the prior year; however, short-term use of insulin for acute conditions is allowed (≤14 days) in certain situations, such as during a hospitalisation or perioperatively.
•Have had any exposure to GLP-1 analogues (including combination products) or other related compounds within the prior 3 months prior to screening, or any history ever of allergies to these medications. Patients who previously took GLP-1 analogues or related compounds and who discontinued those medications for intolerability or lack of efficacy will not be randomised.
•Have been treated with prescription drugs that promote weight loss or similar body weight loss medications including over-the-counter medications within 3 months prior to screening.

Endpoints (9)

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
Safety / tolerability / PK
3
Weight & body composition
2

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Absolute Change in Body Weight From Baseline at Week 12 and 24

Time frame:12 and 24 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percent Change in Body Weight From Baseline at Week 12 and 24

Time frame:12 and 24 weeks

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

Absolute change in HbA1c From Baseline at Week 24

Time frame:24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Absolute change in HbA1c from baseline to 12 weeks

Time frame:12 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG) From Baseline at Week 12 and 24.

Time frame:12 and 24 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in 7-Point Self-Monitored Plasma Glucose (SMPG) Profile at Week 12 and 24.

Time frame:12 and 24 weeks

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame:24 weeks

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any), Discontinuation due to AE

Secondary/protocol endpoint

Incidence of Adverse Events of Special Interest (AESIs) - Gastrointestinal

Time frame:24 weeks

threshold achievement, event

componentsNausea, Vomiting, Diarrhea

Secondary/protocol endpoint

Incidence of anti-drug antibodies (ADA) to PG-102

Time frame:24 weeks

Immunogenicity (ADA)

descriptive

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.