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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06595238




Registration number
NCT06595238
Ethics application status
Date submitted
11/09/2024
Date registered
19/09/2024

Titles & IDs
Public title
A Study in Participants With Obesity or Overweight With at Least One Weight-related Comorbidity
Scientific title
A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD6234 in Participants Living With Obesity or Overweight With Comorbidity
Secondary ID [1] 0 0
2024-514000-13-00
Secondary ID [2] 0 0
D8750C00004
Universal Trial Number (UTN)
Trial acronym
APRICUS
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 - AZD6234
Treatment: Drugs - Placebo comparator

Experimental: Arm 1 - Dose 1

Experimental: Arm 2 - Dose 2

Experimental: Arm 3 - Dose 3

Placebo comparator: Arm 4 - Placebo - Dose matched with each Experimental arm


Treatment: Drugs: AZD6234
IMP injected subcutaneously, once a week. Unit dose strength as per CSP

Treatment: Drugs: Placebo comparator
Placebo matching IMP dose injected subcutaneously, once a week.
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 to week 26
Timepoint [1] 0 0
26 weeks
Primary outcome [2] 0 0
Weight loss = 5% from baseline weight to week 26
Timepoint [2] 0 0
26 weeks
Secondary outcome [1] 0 0
Weight loss = 5% from baseline to week 36
Timepoint [1] 0 0
36 weeks
Secondary outcome [2] 0 0
Weight loss = 10% from baseline to week 36
Timepoint [2] 0 0
36 weeks
Secondary outcome [3] 0 0
Percent change in body weight from baseline to week 36
Timepoint [3] 0 0
36 weeks
Secondary outcome [4] 0 0
Absolute change in body weight (kg) from baseline to week 26 and week 36
Timepoint [4] 0 0
week 26 and week 36
Secondary outcome [5] 0 0
AZD6234 plasma concentrations
Timepoint [5] 0 0
Week 43

Eligibility
Key inclusion criteria
* Adults = 18 years of age
* BMI of (a) = 30 kg/m2, or (b) = 27kg/m2 and have a current diagnosis of at least 1 weight-related comorbidities (treated or untreated)
* A stable body weight for 3 months prior to Screening (±5% body weight change)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome
* Has received prescription or non-prescription medication for weight loss within the last 3 months prior to Screening
* Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier)
* History of type 1 diabetes mellitus or T2DM

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
1/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/01/2026
Actual
Sample size
Target
231
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Heidelberg West
Recruitment hospital [2] 0 0
Research Site - Maroochydore
Recruitment hospital [3] 0 0
Research Site - Maroubra
Recruitment hospital [4] 0 0
Research Site - Merewether
Recruitment postcode(s) [1] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [2] 0 0
4556 - Maroochydore
Recruitment postcode(s) [3] 0 0
2035 - Maroubra
Recruitment postcode(s) [4] 0 0
2291 - Merewether
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
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Mississippi
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New Hampshire
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Japan
State/province [19] 0 0
Chuo-ku
Country [20] 0 0
Japan
State/province [20] 0 0
Shinjuku-ku
Country [21] 0 0
Japan
State/province [21] 0 0
Suita-shi
Country [22] 0 0
Poland
State/province [22] 0 0
Krakow
Country [23] 0 0
Poland
State/province [23] 0 0
Kraków
Country [24] 0 0
Poland
State/province [24] 0 0
Lublin
Country [25] 0 0
Poland
State/province [25] 0 0
Poznan
Country [26] 0 0
Poland
State/province [26] 0 0
Warszawa
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Airdrie
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Hull
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Leicester
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Penarth
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Rotherham

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/NCT06595238