NCT07187856尚未招募2 期
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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Absolute change in HbA1c From Baseline at Week 24
研究概览
简要总结
Phase 2 Randomized Study of PG-102 vs Placebo and Semaglutide in Type 2 Diabetes Mellitus
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
PG-102 and Placebo are administered double-blind; the Semaglutide comparator arm is open-label.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
PG-102
Experimental
Participants receive PG-102 administered subcutaneously once weekly with dose titration.
干预措施: PG-102 (Drug)
Placebo
Placebo Comparator
Participants receive matching placebo administered subcutaneously once weekly.
干预措施: Placebo (Drug)
Semaglutide
Active Comparator
Participants receive open-label semaglutide administered subcutaneously once weekly, titrated to 1.0 mg.
干预措施: Semaglutide (Drug)
结局指标
主要结局
Absolute change in HbA1c From Baseline at Week 24
时间窗: 24 weeks
Mean absolute change in glycated hemoglobin (HbA1c) from baseline to Week 24, comparing PG-102 with placebo.
次要结局
- Change in 7-Point Self-Monitored Plasma Glucose (SMPG) Profile at Week 12 and 24.(12 and 24 weeks)
- 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)
- Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(24 weeks)
- Incidence of Adverse Events of Special Interest (AESIs) - Gastrointestinal(24 weeks)
- Incidence of anti-drug antibodies (ADA) to PG-102(24 weeks)
研究者
研究点 (1)
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