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Phase 2 Randomized Study of PG-102 vs Placebo and Semaglutide in Type 2 Diabetes Mellitus | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

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

NCT07187856•ProGen. Co., Ltd.

View on ClinicalTrials.gov

Summary

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Emeritus Research

Camberwell, Victoria, Australia

Key Dates

Start Date

January 1, 2026

Primary Completion Date

September 1, 2026

Completion Date

December 1, 2026

Last Updated

September 23, 2025

Enrollment

ESTIMATED participants

Conditions

Type 2 Diabetes Mellitus (T2DM)

Interventions

PG-102

DRUG

Placebo

DRUG

Semaglutide

DRUG

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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