The purpose of this study is to determine whether treatment with AZD9550 when given in combination with AZD6234 as once weekly subcutaneous (SC) injections is superior to placebo or either agent administered as monotherapy for weight loss in participants living with obesity or overweight with at least one weight-related co-morbidity. (ASCEND)

Astrazeneca K.K0 个研究点目标入组 45 人开始时间: 2025年4月11日最近更新: 2025年6月4日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Astrazeneca K.K
入组人数: 45
主要终点: Percent change in body weight from baseline after 36 weeks of treatment

暂无简介。

•Participant must be 18 to 75 years of age inclusive.
•BMI: or more 30 kg/m2, or or more 27 kg/m2 with at least one weight related comorbidity.
•A stable, self-reported body weight for 3 months prior to screening.
•Male and female participants: Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
•Female participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline.
•Capable of giving signed informed consent.

•History of any clinically important disease or disorder, which, in the opinion of the Investigator, may put the participant at risk.
•History or presence of GI, renal, hepatic disease.
•Previous or planned bariatric surgery or fitting of a weight loss device.
•Obesity induced by endocrine disorders such as Cushing's syndrome, insulinoma or Prader-Willi syndrome.
•History of T1DM or T2DM or symptoms indicative of insulinopenia or poor glucose control.
•HbA1c or more 6.5% (48 mmol/mol), fasting serum glucose or more 126 mg/dL (7.0 mmol/L) or random glucose or more 200 mg/dL (11.1 mmol/L).
•Significant gastric and hepatobiliary disease.
•History of acute or chronic pancreatitis or pancreatic amylase or lipase > 2 x ULN at screening.
•History of psychosis or bipolar disorder.
•History of major depressive disorder within the 2 years prior to screening or depression.
•Treatment with a GLP1 containing preparation, either as part of treatment or while participating in another clinical study within the 3 months or 5 half-lives of the drug prior to screening.
•Vulnerable populations

Percent change in body weight from baseline after 36 weeks of treatment

时间窗: 36 weeks

To determine whether treatment with AZD9550 and AZD6234 in combination is superior to placebo for weight loss

Weight loss or more 5% from baseline after 36 weeks of treatment

时间窗: 36 weeks

To assess the effect of treatment with AZD9550 and AZD6234 in combination vs placebo on the proportion of participants with weight loss or more 5%.

未报告次要终点

发起方