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)

Status: Active_not_recruiting
Location: See all (53) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
United States
Alabama
Research Site
Dothan
Research Site
Vestavia Hills
California
Research Site
Cerritos
Research Site
Escondido
Research Site
Huntington Park
Research Site
Lincoln
Research Site
Sacramento
Connecticut
Research Site
Waterbury
Florida
Research Site
Palm Harbor
Georgia
Research Site
Decatur
Research Site
Stockbridge
Iowa
Research Site
Sioux City
Illinois
Research Site
Champaign
Indiana
Research Site
South Bend
Research Site
Valparaiso
Michigan
Research Site
Southfield
Montana
Research Site
Missoula
North Dakota
Research Site
Fargo
Nebraska
Research Site
Omaha
New Mexico
Research Site
Albuquerque
Ohio
Research Site
Cincinnati
Research Site
Columbus
Oklahoma
Research Site
Tulsa
Oregon
Research Site
Medford
Tennessee
Research Site
Kingsport
Texas
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Brownsville
Research Site
Houston
Virginia
Research Site
Arlington
Washington
Research Site
Renton
Other Locations
Australia
Research Site
Maroochydore
Research Site
Maroubra
Research Site
Norwood
Research Site
St Albans
Research Site
St Leonards
Canada
Research Site
Calgary
Research Site
Guelph
Research Site
Hamilton
Research Site
Hamilton
Research Site
Montreal
Research Site
Sarnia
Research Site
Stouffville
Research Site
Surrey
Germany
Research Site
Berlin
Research Site
Essen
Research Site
Falkensee
Research Site
Hamburg
Research Site
Münster
Research Site
Oldenburg
Japan
Research Site
Chūōku
Research Site
Chūōku
Research Site
Fukuoka
Research Site
Shinjuku-ku
Research Site
Suita-shi
Time Frame
Start Date: 2025-02-18
Completion Date: 2026-05-25
Participants
Target number of participants: 377
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov