A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Proof-of-Concept Study to Investigate Efficacy and Safety of Oral Azelaprag Plus Once Weekly Tirzepatide Compared With Tirzepatide Alone in Participants With Obesity Aged 55 Years and Over (STRIDES)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 204
- 试验地点
- 14
- 主要终点
- Mean Percent Change in Body Weight (Azelaprag Once per Day)
研究概览
简要总结
This study aims to find out how well a combination of oral azelaprag taken once a day (QD) or twice a day (BID), along with a weekly injection of tirzepatide, works for weight management in adults 55 years and older. The researchers are also looking at safety.
Estimated Study Length:
- with the optional prescreening, the study duration may be up to 48 weeks.
- the treatment duration will be 24 weeks followed by 12 weeks follow-up.
- the visit frequency will be every 2 weeks for the first 8 weeks of the treatment period and every 4 weeks thereafter.
详细描述
Clinical trial BGE-105-005 will determine if the addition of oral azelaprag to tirzepatide treatment will amplify overall weight loss in participants with obesity aged 55 years and older. BGE-105-005 is a randomized, double-blind, placebo-controlled, parallel-arm, multi-center study in approximately 220 adults ≥55 years old with body mass index (BMI) between 30 and 40 kg/m2 inclusive, at the time of screening. Participants will be randomly assigned to 1 of the 4 study arms (A-tirzepatide monotherapy, B-azelaprag 300 mg QD plus tirzepatide, C-azelaprag 300 mg BID plus tirzepatide, D-azelaprag 300 mg BID monotherapy). The primary endpoint will be the effect on body weight reduction as measured by mean percent change in body weight at 24 weeks in participants that received azelaprag plus tirzepatide versus tirzepatide alone. The study is intended to gather safety and efficacy data in the defined participant population.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 55 years of age or older at the time of signing the informed consent.
- •Have a BMI between 30 and 40 kg/m2 inclusive at the time of screening.
- •Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
排除标准
- •Have diagnosis of type 1 diabetes (T1D) or Type 2 diabetes (T2D) mellitus.
- •Have a self-reported change in body weight greater than 5 kg (11 lbs) within 90 days prior to screening.
- •Have a prior or planned surgical treatment or device-based therapy for obesity.
- •Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2).
- •Have an uncontrolled thyroid disease.
- •Have obesity induced by endocrinological disorders.
- •Have biopsy-confirmed nonalcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH).
- •Have a known history or presence of severe active acute or chronic livers disease or acute or chronic pancreatitis, or exocrine pancreatic insufficiency.
- •Have a known history or presence of symptomatic gallbladder disease within the past 2 years.
- •Have a medically significant cardiovascular condition.
- •Have a history of active or untreated malignancy within the last 5 years.
- •Have a history of significant active or unstable major depressive disorder or other severe psychiatric disorder within the last 2 years.
- •Have any lifetime history of a suicide attempt.
- •Have a known clinically significant gastric emptying abnormality.
- •Have had previous or are currently on treatment with a GLP-1R agonist or tirzepatide (a dual agonist of GLP-1 and GIP receptors).
- •Are currently using warfarin.
- •Have used any weight loss drugs, including herbal or nutritional supplements, within 90 days of screening.
- •Have current or history of treatment with medications that may cause significant weight gain within 90 days of screening.
研究组 & 干预措施
A: Tirzepatide Monotherapy
- Azelaprag placebo every morning
- Azelaprag placebo every evening
- Tirzepatide 5mg once weekly
干预措施: Oral Placebo for Azelaprag (BGE-105) (Drug)
A: Tirzepatide Monotherapy
- Azelaprag placebo every morning
- Azelaprag placebo every evening
- Tirzepatide 5mg once weekly
干预措施: Tirzepatide (Drug)
B: Azelaprag once daily plus Tirzepatide
- Azelaprag 300mg every morning
- Azelaprag placebo every evening
- Tirzepatide 5mg once weekly
干预措施: Oral Azelaprag (BGE-105) (Drug)
B: Azelaprag once daily plus Tirzepatide
- Azelaprag 300mg every morning
- Azelaprag placebo every evening
- Tirzepatide 5mg once weekly
干预措施: Oral Placebo for Azelaprag (BGE-105) (Drug)
B: Azelaprag once daily plus Tirzepatide
- Azelaprag 300mg every morning
- Azelaprag placebo every evening
- Tirzepatide 5mg once weekly
干预措施: Tirzepatide (Drug)
C: Azelaprag twice daily plus Tirzepatide
- Azelaprag 300mg every morning
- Azelaprag 300mg every evening
- Tirzepatide 5mg once weekly
干预措施: Oral Azelaprag (BGE-105) (Drug)
C: Azelaprag twice daily plus Tirzepatide
- Azelaprag 300mg every morning
- Azelaprag 300mg every evening
- Tirzepatide 5mg once weekly
干预措施: Tirzepatide (Drug)
D: Azelaprag Monotherapy
- Azelaprag 300mg every morning
- Azelaprag 300mg every evening
- Tirzepatide placebo once weekly
干预措施: Oral Azelaprag (BGE-105) (Drug)
D: Azelaprag Monotherapy
- Azelaprag 300mg every morning
- Azelaprag 300mg every evening
- Tirzepatide placebo once weekly
干预措施: Tirzepatide Placebo (Drug)
结局指标
主要结局
Mean Percent Change in Body Weight (Azelaprag Once per Day)
时间窗: Week 24
Mean percent change in body weight from baseline to Week 24 in the 300 mg azelaprag once per day (QD) plus tirzepatide arm compared to tirzepatide alone arm
Mean Percent Change in Body Weight (Azelaprag Twice per Day)
时间窗: Week 24
Mean percent change in body weight from baseline to Week 24 in the 300 mg azelaprag twice per day (BID) plus tirzepatide arm compared to tirzepatide alone arm
次要结局
- ≥20% Body Weight Reduction(Week 24)
- ≥10% Body Weight Reduction(Week 24)
- Treatment Emergent Adverse Events(Up to Week 36)
- Serious Adverse Events(Up to Week 36)
- ≥5% Body Weight Reduction(Week 24)
- Waist Circumference Change(Week 24)
- ≥15% Body Weight Reduction(Week 24)
- Body Weight Change(Week 24)