AZD9550 for Obesity | Overweight

Inclusion criteria

• {"criterion_text":"-Participant must be 18 to 75 years of age inclusive"}
• {"criterion_text":"-BMI: ≥ 30 kg/m2, or ≥ 27 kg/m2 with at least one weight related comorbidity"}
• {"criterion_text":"-A stable, self-reported body weight for 3 months prior to screening"}
• {"criterion_text":"-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."}
• {"criterion_text":"-Female participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline"}
• {"criterion_text":"-Capable of giving signed informed consent"}

Exclusion criteria

• {"criterion_text":"-History of any clinically important disease or disorder, which, in the opinion of the Investigator"}
• {"criterion_text":"-History of major depressive disorder within the 2 years prior to screening or depression."}
• {"criterion_text":"-Treatment with a GLP1 containing preparation, either as part of treatment or while participating in another clinical study within the3 months or 5 half-lives of the drug prior to screening"}
• {"criterion_text":"-Vulnerable populations"}
• {"criterion_text":"-History or presence of GI, renal, hepatic disease"}
• {"criterion_text":"-Previous or planned bariatric surgery or fitting of a weight loss device."}
• {"criterion_text":"-Obesity induced by endocrine disorders such as Cushing’s syndrome, insulinoma or Prader-Willi syndrome."}
• {"criterion_text":"-History of T1DM or T2DM or symptoms indicative of insulinopenia or poor glucose control."}
• {"criterion_text":"-HbA1c≥ 6.5% (48 mmol/mol), fasting serum glucose≥126 mg/dL(7.0 mmol/L) or random glucose≥200 mg/dL (11.1 mmol/L)."}
• {"criterion_text":"-Significant gastric and hepatobiliary disease"}
• {"criterion_text":"-History of acute or chronic pancreatitis or pancreatic amylase or lipase > 2 × ULN at screening."}
• {"criterion_text":"-History of psychosis or bipolar disorder."}

Primary endpoints

• {"endpoint_text":"-Percent change in body weight from baseline after 36 weeks of treatment","definition_or_measurement_approach":"Percent change in body weight from baseline measured after 36 weeks of treatment"}
• {"endpoint_text":"-Weight loss ≥ 5% from baseline after 36 weeks of treatment","definition_or_measurement_approach":"Proportion of participants achieving weight loss ≥ 5% from baseline measured after 36 weeks of treatment"}

Secondary endpoints

• {"endpoint_text":"-Absolute change in body weight from baseline after 36 weeks of treatment","definition_or_measurement_approach":"Absolute change in body weight from baseline measured after 36 weeks of treatment"}
• {"endpoint_text":"-Percent and absolute change in body weight from baseline after 36 weeks of treatment","definition_or_measurement_approach":"Percent and absolute change in body weight from baseline measured after 36 weeks of treatment"}
• {"endpoint_text":"-Weight loss ≥ 5% from baseline after 36 weeks of treatment","definition_or_measurement_approach":"Proportion of participants achieving ≥5% weight loss at 36 weeks"}
• {"endpoint_text":"-Weight loss ≥ 10% and ≥ 15% from baseline after 36 weeks of treatment","definition_or_measurement_approach":"Proportion of participants achieving ≥10% and ≥15% weight loss at 36 weeks"}
• {"endpoint_text":"-Prevalence, incidence and titres of ADAs to AZD9550 andAZD6234 in combination and as monotherapies after 36 weeks of treatment","definition_or_measurement_approach":"Assessment of anti-drug antibodies (ADAs) prevalence, incidence and titres to AZD9550 and AZD6234 after 36 weeks"}
• {"endpoint_text":"-To evaluate the safety and tolerability of AZD9550 and AZD6234 in combination compared with placebo and with monotherapy","definition_or_measurement_approach":"Safety and tolerability assessments comparing combination therapy, monotherapies and placebo over 36 weeks"}

Methods

• K1_Recruitment Arrangements_Germany (document listed) — recruitment arrangements for Germany (document title only available)
• K2_Recruitment Material Poster (document listed) — site posters (document title)
• K2_Recruitment Material Digital Advert (document listed) — digital advertising material (document title)
• K2_Recruitment Material Mannheim I and Mannheim II (document titles) — local/site recruitment materials

Germany

Earliest CTIS Part Ii Submission Date

16-01-2025

Latest Decision Or Authorization Date

22-12-2025

Processing Time Days

340

Number Of Sites

6

Number Of Participants

40

Primary sponsor

Full Name

AstraZeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden