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

ProGen. Co., Ltd.

Status and phase: Not yet enrolling; Phase 2

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Drug: Placebo; Drug: Semaglutide; Drug: PG-102

Study type: Interventional

Funder types: Other

Identifiers

NCT07187856

PG-102-P2-WW-01

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 3 patient groups, including a placebo group

PG-102

Experimental group

Description:

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

Treatment:

Drug: PG-102

Placebo

Placebo Comparator group

Description:

Participants receive matching placebo administered subcutaneously once weekly.

Treatment:

Drug: Placebo

Semaglutide

Active Comparator group

Description:

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

Treatment:

Drug: Semaglutide