A Weight Loss Study Evaluating Subcutaneous Treatment With AZD9550 and AZD6234 in Combination Aga… (NCT06862791) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Weight Loss Study Evaluating Subcutaneous Treatment With AZD9550 and AZD6234 in Combination Against Placebo or Each of the Drugs Alone
United States377 participantsStarted 2025-02-18
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Participant must be 18 to 75 years of age inclusive.
* BMI: ≥ 30 kg/m2, or ≥ 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.
Exclusion Criteria:
* 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 ≥ 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).
* Significant gastric and hepatobiliary disease.
* History of acute or chronic pancreatitis or pancreatic amylase or lipase \> 2 × ULN at screening.
* History of psychosis or bipolar disorder.
* History of major depressive disorder within the 2 years prior to screening or depression.
* Treatment wit…
What they're measuring
1
Percent change in body weight from baseline after 36 weeks of treatment
Timeframe: 36 weeks
2
Weight loss ≥ 5% from baseline after 36 weeks of treatment