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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06862791




Registration number
NCT06862791
Ethics application status
Date submitted
14/02/2025
Date registered
6/03/2025

Titles & IDs
Public title
A Weight Loss Study Evaluating Subcutaneous Treatment With AZD9550 and AZD6234 in Combination Against Placebo or Each of the Drugs Alone
Scientific title
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)
Secondary ID [1] 0 0
2024-516176-15-00
Secondary ID [2] 0 0
D8460C00004
Universal Trial Number (UTN)
Trial acronym
ASCEND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity or Overweight 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZD9550
Treatment: Drugs - AZD6234
Treatment: Drugs - Placebo comparator

Experimental: Arm 1 - AZD9550 low dose + AZD6234 low dose or placebos

Experimental: Arm 2 - AZD9550 medium dose + AZD6234 medium dose or placebos

Experimental: Arm 3 - AZD9550 high dose + AZD6234 high dose or placebos

Experimental: Arm 4 - AZD9550 low dose + AZD6234 medium dose or placebos

Experimental: Arm 5 - AZD9550 medium dose + AZD6234 low dose or placebos

Experimental: Arm 6 - AZD9550 high dose + AZD6234 medium dose or placebos

Experimental: Arm 7 - AZD9550 medium dose + AZD6234 high dose or placebos

Experimental: Arm 8 - AZD9550 high dose or placebo

Experimental: Arm 9 - AZD6234 high dose or placebo


Treatment: Drugs: AZD9550
IMP injected subcutaneous, once weekly. Unit dose strength as per CSP

Treatment: Drugs: AZD6234
IMP injected subcutaneous, once weekly. Unit dose strength as per CSP.

Treatment: Drugs: Placebo comparator
Placebo matching IMP dose injected subcutaneously, once weekly.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent change in body weight from baseline after 36 weeks of treatment
Timepoint [1] 0 0
36 weeks
Primary outcome [2] 0 0
Weight loss = 5% from baseline after 36 weeks of treatment
Timepoint [2] 0 0
36 weeks
Secondary outcome [1] 0 0
Absolute change in body weight from baseline after 36 weeks of treatment
Timepoint [1] 0 0
36 weeks
Secondary outcome [2] 0 0
Absolute change in body weight from baseline after 36 weeks of treatment
Timepoint [2] 0 0
36 weeks
Secondary outcome [3] 0 0
Weight loss = 5% from baseline after 36 weeks of treatment
Timepoint [3] 0 0
36 weeks
Secondary outcome [4] 0 0
Weight loss = 10% and = 15% from baseline after 36 weeks of treatment
Timepoint [4] 0 0
36 weeks
Secondary outcome [5] 0 0
Prevalence of ADAs to AZD9550 and AZD6234 in combination and as monotherapies after 36 weeks of treatment
Timepoint [5] 0 0
36 weeks
Secondary outcome [6] 0 0
Incidence of ADAs to AZD9550 and AZD6234 in combination and as monotherapies after 36 weeks of treatment
Timepoint [6] 0 0
36 weeks
Secondary outcome [7] 0 0
Titres of ADAs to AZD9550 and AZD6234 in combination and as monotherapies after 36 weeks of treatment
Timepoint [7] 0 0
36 weeks
Secondary outcome [8] 0 0
Percent change in body weight from baseline after 36 weeks of treatment
Timepoint [8] 0 0
36 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/06/2026
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Maroochydore
Recruitment hospital [2] 0 0
Research Site - Maroubra
Recruitment hospital [3] 0 0
Research Site - Norwood
Recruitment hospital [4] 0 0
Research Site - St Albans
Recruitment hospital [5] 0 0
Research Site - St Leonards
Recruitment postcode(s) [1] 0 0
4556 - Maroochydore
Recruitment postcode(s) [2] 0 0
2035 - Maroubra
Recruitment postcode(s) [3] 0 0
5067 - Norwood
Recruitment postcode(s) [4] 0 0
3021 - St Albans
Recruitment postcode(s) [5] 0 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Montana
Country [16] 0 0
United States of America
State/province [16] 0 0
Nebraska
Country [17] 0 0
United States of America
State/province [17] 0 0
New Mexico
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Dakota
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oklahoma
Country [22] 0 0
United States of America
State/province [22] 0 0
Oregon
Country [23] 0 0
United States of America
State/province [23] 0 0
Tennessee
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Virginia
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
Canada
State/province [27] 0 0
Alberta
Country [28] 0 0
Canada
State/province [28] 0 0
British Columbia
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
Germany
State/province [31] 0 0
Berlin
Country [32] 0 0
Germany
State/province [32] 0 0
Essen
Country [33] 0 0
Germany
State/province [33] 0 0
Falkensee
Country [34] 0 0
Germany
State/province [34] 0 0
Hamburg
Country [35] 0 0
Germany
State/province [35] 0 0
Mannheim
Country [36] 0 0
Germany
State/province [36] 0 0
Muenster
Country [37] 0 0
Germany
State/province [37] 0 0
Oldenburg
Country [38] 0 0
Japan
State/province [38] 0 0
Chuo-ku
Country [39] 0 0
Japan
State/province [39] 0 0
Fukuoka-shi
Country [40] 0 0
Japan
State/province [40] 0 0
Shinjuku-ku
Country [41] 0 0
Japan
State/province [41] 0 0
Suita-shi
Country [42] 0 0
Taiwan
State/province [42] 0 0
Kaohsiung

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06862791