NCT05297045终止2 期
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging Study of Oral RGT001-075 in Adult Patients With Uncontrollable Type 2 Diabetes Mellitus on Metformin Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in HbA1c from baseline to end of treatment in the modified intent-to-treat population
研究概览
简要总结
This is a phase 2 study designed to evaluate the efficacy of daily (QD) oral RGT001-075 GLP1 receptor agonist relative to placebo after up to 16 weeks of double-blind treatment as determined by mean change from baseline in HbA1c in adult patients with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic control with diet and exercise and stable metformin treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosed with type 2 diabetes that has been treated with lifestyle modification and a stable dose of metformin ≥1000 mg/day (or maximum tolerated dose) for at least 3 months at the time of Screening
- •Screening HbA1c 7.0-10.5%
- •Male or female, age 18-75 years
- •Screening BMI 24.5 - 40 kg/m2
- •Either surgically sterile, abstinent, or willing to use a highly effective method of contraception for the entirety of the study, and not be pregnant or lactating if a woman of child-bearing potential
排除标准
- •Has received within the preceding 3 months prior to Screening, another approved or investigational oral or injectable antidiabetic medication (including, but not limited to sulfonylureas, dipeptidyl peptidase-4 inhibitor [DPP-4i], sodium-glucose cotransport 2 inhibitors, alphaglucosidase inhibitors, meglitinides, thiazolidinediones) or insulin in addition to metformin therapy
- •Has active GI disease including acute or chronic pancreatitis, severe gastroparesis or chronic malabsorption, inflammatory bowel disease, symptomatic gallbladder or biliary disease, known unstable liver disease, a diagnosis of fibrotic nonalcoholic steatohepatitis (NASH), Gilbert's syndrome, or obvious clinical signs or symptoms of liver disease including chronic active hepatitis B or C, or primary biliary cirrhosis, or elevated alanine aminotransferase (ALT) levels at Screening
- •Has any history of myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary therapeutic intervention, transient ischemic attack, stroke, or decompensated congestive heart failure within previous 6 months prior to Screening
- •Has an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2
- •Has active proliferative diabetic retinopathy or macular edema
- •Has a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid cancer
- •Has an active or untreated malignancy or has been in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for <5 years prior to screening
- •Has evidence of human immunodeficiency virus (HIV) and/or positive HIV antibodies historically or at screening
- •Has had a significant change in weight, defined as a gain or loss of at least 5% body weight in the 3 months prior to screening
- •Has been treated or plan to be treated with drugs or devices or surgery that promote weight loss within 3 months prior to screening
研究组 & 干预措施
Dose Group C
Experimental
干预措施: RGT001-075 (Drug)
Dose Group A
Experimental
干预措施: RGT001-075 (Drug)
Dose Group B
Experimental
干预措施: RGT001-075 (Drug)
Dose Group D
Experimental
干预措施: RGT001-075 (Drug)
Dose Group E
Experimental
干预措施: RGT001-075 (Drug)
Dose Group F
Experimental
干预措施: RGT001-075 (Drug)
Placebo Group
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Change in HbA1c from baseline to end of treatment in the modified intent-to-treat population
时间窗: up to 16 weeks
次要结局
- Change in fasting plasma glucose from baseline to end of treatment in the modified intent-to-treat population(up to 16 weeks)
- Change in body mass index from baseline to end of treatment in the modified intent-to-treat population(up to 16 weeks)
- Change in waist circumference from baseline to end of treatment in the modified intent-to-treat population(up to 16 weeks)
- Vital signs - Systolic blood pressure (mmHg) absolute change from baseline(up to 16 weeks)
- Vital signs - Diastolic blood pressure (mmHg) absolute change from baseline(up to 16 weeks)
- Vital signs - Heart rate (beats/minute) absolute change from baseline(up to 16 weeks)
- Vital signs - Body weight (kg) absolute and percent change from baseline(up to 16 weeks)
- Safety clinical laboratories - complete blood count absolute change from baseline(up to 16 weeks)
- Safety clinical laboratories - serum potassium absolute change from baseline(up to 16 weeks)
- Safety clinical laboratories - serum total bilirubin absolute change from baseline(up to 16 weeks)
- Safety clinical laboratories - serum alkaline phosphatase absolute change from baseline(up to 16 weeks)
- Safety clinical laboratories - serum alanine aminotransferase absolute change from baseline(up to 16 weeks)
- Safety clinical laboratories - serum aspartate aminotransferase absolute change from baseline(up to 16 weeks)
- Safety clinical laboratories - serum creatinine absolute change from baseline(up to 16 weeks)
- Safety clinical laboratories - serum uric acid absolute change from baseline(up to 16 weeks)
- Safety clinical laboratories - serum calcium absolute change from baseline(up to 16 weeks)
- Change in mean body weight (absolute and %) from baseline to end of treatment in the modified intent-to-treat population(up to 16 weeks)
- Change in mean blood lipids including triglycerides (TG), high-density lipoprotein (HDL), and low-density lipoprotein (LDL) from baseline to end of treatment in the modified intent-to-treat population(up to 16 weeks)
- Percentages of patients achieving HbA1c <6.0%, <6.5%, and/or <7.0%(up to 16 weeks)
- Safety clinical laboratories - serum sodium absolute change from baseline(up to 16 weeks)
- Safety clinical laboratories - serum direct bilirubin absolute change from baseline(up to 16 weeks)
- Safety clinical laboratories - fasting serum LDL-C absolute and percent change from baseline(up to 16 weeks)
- Safety clinical laboratories - serum calcitonin absolute change from screening(up to 16 weeks)
- Percentages of patients achieving ≥5% and/or ≥10% greater body weight loss(up to 16 weeks)
- Incidence of treatment-emergent adverse events (TEAE)s, serious adverse events (SAE)s, deaths, and adverse events (AE)s leading to study discontinuation(up to 16 weeks)
- Safety clinical laboratories - serum blood urea nitrogen absolute change from baseline(up to 16 weeks)
- Safety clinical laboratories - serum lipase absolute change from baseline(up to 16 weeks)
- Safety clinical laboratories - serum amylase absolute change from baseline(up to 16 weeks)
- Safety clinical laboratories - eGFR (calculated) absolute change from baseline(up to 16 weeks)
- Safety clinical laboratories - fasting serum glucose absolute change from baseline(up to 16 weeks)
- Safety clinical laboratories - serum albumin absolute change from baseline(up to 16 weeks)
- Safety clinical laboratories - serum total protein absolute change from baseline(up to 16 weeks)
- Safety clinical laboratories - fasting serum total cholesterol absolute change from baseline(up to 16 weeks)
- Safety clinical laboratories - fasting serum triglycerides absolute and percent change from baseline(up to 16 weeks)
- Safety clinical laboratories - fasting serum HDL-C absolute and percent change from baseline(up to 16 weeks)
- ECG interval change from baseline absolute and categorical outliers >450ms(up to 16 weeks)
- Proportion of patients who report AEs of Special Interest (AESI) including GI intolerability, hypoglycemia, drug hypersensitivity reactions, acute pancreatitis, thyroid C-cell hyperplasia and C-cell neoplasms, and cardiovascular (CV) events(up to 16 weeks)
研究者
研究点 (1)
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