A Weight Loss Study Evaluating Subcutaneous Treatment With AZD9550 and AZD6234 in Combination Against Placebo or Each of the Drugs Alone

Launched by ASTRAZENECA · Mar 4, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for people who are overweight or obese, especially those with related health issues. Researchers want to find out if a combination of two medications, AZD9550 and AZD6234, given as a weekly injection under the skin, helps people lose more weight compared to a placebo (a treatment with no active medication) or taking either drug alone. The trial is currently recruiting participants aged 18 to 75 who have a body mass index (BMI) of 30 or higher, or a BMI of 27 or higher if they also have health problems related to their weight.

If you decide to participate, you'll need to have a stable weight for three months before the study and be able to provide informed consent. However, certain health conditions, like severe gastrointestinal or liver diseases, previous weight loss surgeries, or significant mental health issues, may exclude you from joining. Throughout the trial, participants will be monitored closely, and they can expect to receive support and care from the research team as they explore the effectiveness of these treatments for weight loss.

Gender

ALL

Eligibility criteria

• 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 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