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

Официальное название

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

Обзор

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

Вмешательства

• Препарат PG-102
  PG-102 is administered subcutaneously once weekly with a titration regimen.
• Препарат Placebo
  Placebo is administered subcutaneously once weekly.
• Препарат Semaglutide
  Open-label semaglutide is administered subcutaneously once weekly with titration regimen.

Первичные конечные точки

• Absolute change in HbA1c From Baseline at Week 24 [Срок оценки: 24 weeks]

Вторичные конечные точки (8)

• Absolute change in HbA1c from baseline to 12 weeks [Срок оценки: 12 weeks]
• Absolute Change in Body Weight From Baseline at Week 12 and 24 [Срок оценки: 12 and 24 weeks]
• Percent Change in Body Weight From Baseline at Week 12 and 24 [Срок оценки: 12 and 24 weeks]
• Change in Fasting Plasma Glucose (FPG) From Baseline at Week 12 and 24. [Срок оценки: 12 and 24 weeks]
• Change in 7-Point Self-Monitored Plasma Glucose (SMPG) Profile at Week 12 and 24. [Срок оценки: 12 and 24 weeks]
• Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Срок оценки: 24 weeks]
• Incidence of Adverse Events of Special Interest (AESIs) - Gastrointestinal [Срок оценки: 24 weeks]
• Incidence of anti-drug antibodies (ADA) to PG-102 [Срок оценки: 24 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• Emeritus Research — Camberwell

Идентификаторы

NCT: NCT07187856 · PG-102-P2-WW-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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