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

NCT ID: NCT07187856

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-12-31

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus (T2DM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PG-102

Participants receive PG-102 administered subcutaneously once weekly with dose titration.

Group Type: EXPERIMENTAL

PG-102

Intervention Type: DRUG

PG-102 is administered subcutaneously once weekly with a titration regimen.

Placebo

Participants receive matching placebo administered subcutaneously once weekly.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo is administered subcutaneously once weekly.

Semaglutide

Participants receive open-label semaglutide administered subcutaneously once weekly, titrated to 1.0 mg.

Group Type: ACTIVE_COMPARATOR

Semaglutide

Intervention Type: DRUG

Open-label semaglutide is administered subcutaneously once weekly with titration regimen.

Interventions

PG-102

PG-102 is administered subcutaneously once weekly with a titration regimen.

Intervention Type: DRUG

Placebo

Placebo is administered subcutaneously once weekly.

Intervention Type: DRUG

Semaglutide

Open-label semaglutide is administered subcutaneously once weekly with titration regimen.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ProGen. Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Emeritus Research

Camberwell, Victoria, Australia

Countries

Australia

Central Contacts

Kyunghwa Son, Ph.D

Role: CONTACT

khson@progen.co.kr

+82-2-6098-2818

Rosanna Sung

Role: CONTACT

bd@progen.co.kr

+82-2-6098-2849

Facility Contacts

Rishi Shah

Role: primary

rishishah@emeritusresearch.com

0395096166

Other Identifiers

PG-102-P2-WW-01

Identifier Type: -

Identifier Source: org_study_id