A Randomized, Placebo-controlled, Participant-and-investigator- Blinded, Sponsor Open-label Study to Evaluate the Safety, Tolerability, and Efficacy With Different Dosing Regimens of Subcutaneously Administered MBL949 in Obese Participants With or Without Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Frequency and Severity of Adverse Events
研究概览
简要总结
This was a multi-center, randomized, placebo-controlled, participant-and-investigator-blinded, sponsor open-label study in obese participants with or without Type 2 Diabetes Mellitus.
详细描述
The study comprised a screening/baseline period of up to 35 days (5 weeks), a 14-week treatment period in which participants were administered MBL949 or placebo at 8 biweekly intervals starting on Day 1 and a 10-week follow-up period.
Participants were to be enrolled to:
- MBL949 Arm 1, MBL949 Arm 2 and placebo in a 1:1:1 ratio
- MBL949 Arm 3, MBL949 Arm 4 and placebo in a 1:1:1 ratio
- If MBL949 Arm 1 was tolerated, MBL949 Arm 5 was enrolled with a 2:1 ratio (MBL:placebo) within each stratum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index: ≥ 32 kg/m2, weight ≥ 77 kg, stable body weight i.e., less than 1.5 kg self-reported change within 90 days
- •Diagnosed T2DM as documented by medical history and confirmed by Investigator and with diagnosed duration < 10 yrs, HbA1c ≤ 9%, and fasting C-peptide ≥ 0.2 ng/ml
- •If treated for T2DM, treatment must be limited to diet and exercise and treatment with one of the following anti-diabetic agents (stable for 90 days prior to randomization):
- •Metformin
- •SGLT2i inhibitors (if prescribed as the first line, ie. single agent)
- •DDP4 inhibitors
排除标准
- •Vitals at screening:
- •systolic blood pressure less than 95 mm Hg or greater than 155 mm Hg
- •diastolic blood pressure less than 60 mg Hg or greater than 95 mm Hg
- •pulse rate less than 56 or greater than 110 bpm
- •History of bariatric surgery, Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, gastric banding, and any other intrabdominal procedures designed for weight loss at screening
- •History of myocardial infarction with 2 years of screening
- •Diet attempts within 90 days before screening
- •Participation in organized weight reduction program within 6 months of screening
研究组 & 干预措施
MBL949 Arm 1
MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 4.5 mg
干预措施: MBL949 (Drug)
MBL949 Arm 2
MBL949 two 3 mg doses followed by six doses of 4.5 mg
干预措施: MBL949 (Drug)
MBL949 Arm 3
MBL949 one 12 mg dose followed by seven doses of 4.5 mg
干预措施: MBL949 (Drug)
MBL949 Arm 4
MBL949 one 1.5 mg dose followed by seven doses of 2.2 mg
干预措施: MBL949 (Drug)
MBL949 Arm 5
MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 7.5 mg
干预措施: MBL949 (Drug)
Placebo
Placebo to MBL949
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency and Severity of Adverse Events
时间窗: Baseline to Day 169
Number of participants with adverse events reported after the first dose of study medication or events present prior to treatment but increase in severity
Change-from-baseline in Weight
时间窗: Week 16
Baseline weight is defined as the last weight measurement before dosing in kilograms
次要结局
未报告次要终点