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

ovartis Pharma AG0 个研究点目标入组 106 人开始时间: 2022年2月7日最近更新: 2023年10月30日

适应症

试验速览

暂无简介。

•Participants must be between 18 to 60 years of age inclusive
•- 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 106
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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

发起方