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

NCT07187856 | Not Yet Recruiting Phase 2

• 1 other identifier: PG-102-P2-WW-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (1)

• Absolute change in HbA1c From Baseline at Week 24

  Mean absolute change in glycated hemoglobin (HbA1c) from baseline to Week 24, comparing PG-102 with placebo.

  24 weeks

Secondary Outcomes (8)

• Absolute change in HbA1c from baseline to 12 weeks

  12 weeks

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

  12 and 24 weeks

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

  12 and 24 weeks

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

  12 and 24 weeks

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

  12 and 24 weeks

Study Arms (3)

PG-102

EXPERIMENTAL

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

Drug: PG-102

Placebo

PLACEBO COMPARATOR

Participants receive matching placebo administered subcutaneously once weekly.

Drug: Placebo

Semaglutide

ACTIVE COMPARATOR

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

Drug: Semaglutide

Interventions

PG-102 DRUG

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

PG-102

Placebo DRUG

Placebo is administered subcutaneously once weekly.

Placebo

Semaglutide DRUG

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

Semaglutide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ProGen. Co., Ltd.: lead

Study Sites (1)

Emeritus Research

Camberwell, Victoria, 3124, Australia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Kyunghwa Son, Ph.D

CONTACT

+82-2-6098-2818; khson@progen.co.kr

Rosanna Sung

CONTACT

+82-2-6098-2849; bd@progen.co.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: PG-102 and Placebo are administered double-blind; the Semaglutide comparator arm is open-label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 23, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

AU (1)