A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of Co-administration of AZD9550 and AZD6234 in Participants Living With Obesity or Overweight With Co-morbidity (ASCEND)

JRCT ID: jRCT2051240287

Registered date:07/03/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Obesity or Overweight
• Date of first enrollment: 22/04/2025
• Target sample size: 45
• Countries of recruitment: United States of America,Japan,Canada,Japan,Taiwan,Japan,Australia,Japan,United Kingdom,Japan,Germany,Japan
• Study type: Interventional

Intervention(s)

Experimental: Arm 1: AZD9550 low dose + AZD6234 low dose or placebos
Drug: AZD9550
- IMP injected subcutaneous, once weekly. Unit dose strength as per CSP
Drug: AZD6234
- IMP injected subcutaneous, once weekly. Unit dose strength as per CSP.
Drug: Placebo comparator
- Placebo matching IMP dose injected subcutaneously, once weekly.

Experimental: Arm 2: AZD9550 medium dose + AZD6234 medium dose or placebos
Drug: AZD9550
- IMP injected subcutaneous, once weekly. Unit dose strength as per CSP
Drug: AZD6234
- IMP injected subcutaneous, once weekly. Unit dose strength as per CSP.
Drug: Placebo comparator
- Placebo matching IMP dose injected subcutaneously, once weekly.

Experimental: Arm 3: AZD9550 high dose + AZD6234 high dose or placebos
Drug: AZD9550
- IMP injected subcutaneous, once weekly. Unit dose strength as per CSP
Drug: AZD6234
- IMP injected subcutaneous, once weekly. Unit dose strength as per CSP.
Drug: Placebo comparator
- Placebo matching IMP dose injected subcutaneously, once weekly.

Experimental: Arm 4: AZD9550 low dose + AZD6234 medium dose or placebos
Drug: AZD9550
- IMP injected subcutaneous, once weekly. Unit dose strength as per CSP
Drug: AZD6234
- IMP injected subcutaneous, once weekly. Unit dose strength as per CSP.
Drug: Placebo comparator
- Placebo matching IMP dose injected subcutaneously, once weekly.

Experimental: Arm 5: AZD9550 medium dose + AZD6234 low dose or placebos
Drug: AZD9550
- IMP injected subcutaneous, once weekly. Unit dose strength as per CSP
Drug: AZD6234
- IMP injected subcutaneous, once weekly. Unit dose strength as per CSP.
Drug: Placebo comparator
- Placebo matching IMP dose injected subcutaneously, once weekly.

Experimental: Arm 6: AZD9550 high dose + AZD6234 medium dose or placebos
Drug: AZD9550
- IMP injected subcutaneous, once weekly. Unit dose strength as per CSP
Drug: AZD6234
- IMP injected subcutaneous, once weekly. Unit dose strength as per CSP.
Drug: Placebo comparator
- Placebo matching IMP dose injected subcutaneously, once weekly.

Experimental: Arm 7: AZD9550 medium dose + AZD6234 high dose or placebos
Drug: AZD9550
- IMP injected subcutaneous, once weekly. Unit dose strength as per CSP
Drug: AZD6234
- IMP injected subcutaneous, once weekly. Unit dose strength as per CSP.
Drug: Placebo comparator
- Placebo matching IMP dose injected subcutaneously, once weekly.

Experimental: Arm 8: AZD9550 high dose or placebo
Drug: AZD9550
- IMP injected subcutaneous, once weekly. Unit dose strength as per CSP
Drug: Placebo comparator
- Placebo matching IMP dose injected subcutaneously, once weekly.

Experimental: Arm 9: AZD6234 high dose or placebo
Drug: AZD6234
- IMP injected subcutaneous, once weekly. Unit dose strength as per CSP.
Drug: Placebo comparator
- Placebo matching IMP dose injected subcutaneously, once weekly.

Outcome(s)

Primary Outcome

- Percent change in body weight from baseline after 36 weeks of treatment
To determine whether treatment with AZD9550 and AZD6234 in combination is superior to placebo for weight loss [Time Frame: 36 weeks]

- Weight loss or more 5% from baseline after 36 weeks of treatment
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%. [Time Frame: 36 weeks]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old

Include criteria

- 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.

Exclude 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 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

Related Information

• Primary Sponsor: Ageishi Yuji
• Secondary ID(s): NCT06862791