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

AstraZeneca

Status and phase: Active, not recruiting; Phase 2

Conditions: Obesity or Overweight

Treatments: Drug: AZD6234; Drug: Placebo comparator; Drug: AZD9550

Study type: Interventional

Funder types: Industry

Identifiers

NCT06862791

2024-516176-15-00 (Registry Identifier)

D8460C00004

Details and patient eligibility

About

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.

Full description

This is a Phase IIb, global, randomised, parallel-group, double-blind, placebo-controlled, multi-centre, reduced factorial study designed to evaluate the efficacy, safety and tolerability of treatment with AZD9550 and AZD6234 in combination or as monotherapy in adults who are living with obesity or overweight with at least one of the following weight-related co-morbidities: hypertension, dyslipidemia or obstructive sleep apnoea. The study is composed of a screening period, a treatment period and a follow up period with participants expected to be in the study for approximately 47 weeks. The study will be conducted at around 60 sites and in approximately 7 countries with about, 360 participants will be randomly assigned to study intervention or placebo.

Enrollment: 377 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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377 participants in 9 patient groups

Arm 1

Experimental group

Description:

AZD9550 low dose + AZD6234 low dose or placebos

Treatment:

Drug: AZD9550

Drug: Placebo comparator

Drug: AZD6234

Arm 2

Experimental group

Description:

AZD9550 medium dose + AZD6234 medium dose or placebos

Treatment:

Drug: AZD9550

Drug: Placebo comparator

Drug: AZD6234

Arm 3

Experimental group

Description:

AZD9550 high dose + AZD6234 high dose or placebos

Treatment:

Drug: AZD9550

Drug: Placebo comparator

Drug: AZD6234

Arm 4

Experimental group

Description:

AZD9550 low dose + AZD6234 medium dose or placebos

Treatment:

Drug: AZD9550

Drug: Placebo comparator

Drug: AZD6234

Arm 5

Experimental group

Description:

AZD9550 medium dose + AZD6234 low dose or placebos

Treatment:

Drug: AZD9550

Drug: Placebo comparator

Drug: AZD6234

Arm 6

Experimental group

Description:

AZD9550 high dose + AZD6234 medium dose or placebos

Treatment:

Drug: AZD9550

Drug: Placebo comparator

Drug: AZD6234

Arm 7

Experimental group

Description:

AZD9550 medium dose + AZD6234 high dose or placebos

Treatment:

Drug: AZD9550

Drug: Placebo comparator

Drug: AZD6234

Arm 8

Experimental group

Description:

AZD9550 high dose or placebo

Treatment:

Drug: AZD9550

Drug: Placebo comparator

Arm 9

Experimental group

Description:

AZD6234 high dose or placebo

Treatment:

Drug: Placebo comparator

Drug: AZD6234