A Weight Loss Study Evaluating Subcutaneous Treatment With AZD9550 and AZD6234 in Combination Against Placebo or Each of the Drugs Alone
ASCEND
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)
2 other identifiers
interventional
377
5 countries
53
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2025
Shorter than P25 for phase_2
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2025
CompletedStudy Start
First participant enrolled
February 18, 2025
CompletedFirst Posted
Study publicly available on registry
March 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 25, 2026
April 28, 2026
April 1, 2026
1.3 years
February 14, 2025
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
36 weeks
Weight loss ≥ 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 ≥ 5%
36 weeks
Secondary Outcomes (8)
Absolute change in body weight from baseline after 36 weeks of treatment
36 weeks
Absolute change in body weight from baseline after 36 weeks of treatment
36 weeks
Weight loss ≥ 5% from baseline after 36 weeks of treatment
36 weeks
Weight loss ≥ 10% and ≥ 15% from baseline after 36 weeks of treatment
36 weeks
Prevalence of ADAs to AZD9550 and AZD6234 in combination and as monotherapies after 36 weeks of treatment
36 weeks
- +3 more secondary outcomes
Study Arms (9)
Arm 1
EXPERIMENTALAZD9550 low dose + AZD6234 low dose or placebos
Arm 2
EXPERIMENTALAZD9550 medium dose + AZD6234 medium dose or placebos
Arm 3
EXPERIMENTALAZD9550 high dose + AZD6234 high dose or placebos
Arm 4
EXPERIMENTALAZD9550 low dose + AZD6234 medium dose or placebos
Arm 5
EXPERIMENTALAZD9550 medium dose + AZD6234 low dose or placebos
Arm 6
EXPERIMENTALAZD9550 high dose + AZD6234 medium dose or placebos
Arm 7
EXPERIMENTALAZD9550 medium dose + AZD6234 high dose or placebos
Arm 8
EXPERIMENTALAZD9550 high dose or placebo
Arm 9
EXPERIMENTALAZD6234 high dose or placebo
Interventions
IMP injected subcutaneous, once weekly. Unit dose strength as per CSP
IMP injected subcutaneous, once weekly. Unit dose strength as per CSP.
Placebo matching IMP dose injected subcutaneously, once weekly.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (53)
Research Site
Dothan, Alabama, 36305, United States
Research Site
Vestavia Hills, Alabama, 35216, United States
Research Site
Cerritos, California, 90703, United States
Research Site
Escondido, California, 92025, United States
Research Site
Huntington Park, California, 90255, United States
Research Site
Lincoln, California, 95648, United States
Research Site
Sacramento, California, 95864, United States
Research Site
Waterbury, Connecticut, 06708, United States
Research Site
Palm Harbor, Florida, 34684, United States
Research Site
Decatur, Georgia, 30030, United States
Research Site
Stockbridge, Georgia, 30281, United States
Research Site
Champaign, Illinois, 61822, United States
Research Site
South Bend, Indiana, 46617, United States
Research Site
Valparaiso, Indiana, 46383, United States
Research Site
Sioux City, Iowa, 51106, United States
Research Site
Southfield, Michigan, 48034, United States
Research Site
Missoula, Montana, 59804, United States
Research Site
Omaha, Nebraska, 68114, United States
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Albuquerque, New Mexico, 87107, United States
Research Site
Fargo, North Dakota, 58104, United States
Research Site
Cincinnati, Ohio, 45219, United States
Research Site
Columbus, Ohio, 43213, United States
Research Site
Tulsa, Oklahoma, 74133, United States
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Medford, Oregon, 97504, United States
Research Site
Kingsport, Tennessee, 37660, United States
Research Site
Brownsville, Texas, 78526, United States
Research Site
Houston, Texas, 77043, United States
Research Site
Arlington, Virginia, 22206, United States
Research Site
Renton, Washington, 98057, United States
Research Site
Maroochydore, 4556, Australia
Research Site
Maroubra, 2035, Australia
Research Site
Norwood, 5067, Australia
Research Site
St Albans, 3021, Australia
Research Site
St Leonards, 2065, Australia
Research Site
Calgary, Alberta, T2V 4J2, Canada
Research Site
Surrey, British Columbia, V3T 4G8, Canada
Research Site
Guelph, Ontario, N1G 0B4, Canada
Research Site
Hamilton, Ontario, L8J 0B6, Canada
Research Site
Hamilton, Ontario, L8L 5G8, Canada
Research Site
Sarnia, Ontario, N7T 4X3, Canada
Research Site
Stouffville, Ontario, L4A1H2, Canada
Research Site
Montreal, Quebec, H4N 2W2, Canada
Research Site
Berlin, 10787, Germany
Research Site
Essen, 45136, Germany
Research Site
Falkensee, 14612, Germany
Research Site
Hamburg, 22607, Germany
Research Site
Münster, 48145, Germany
Research Site
Oldenburg, 23758, Germany
Research Site
Chūōku, 103-0027, Japan
Research Site
Chūōku, 104-0031, Japan
Research Site
Fukuoka, 812-0025, Japan
Research Site
Shinjuku-ku, 160-0008, Japan
Research Site
Suita-shi, 565-0853, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2025
First Posted
March 6, 2025
Study Start
February 18, 2025
Primary Completion (Estimated)
May 25, 2026
Study Completion (Estimated)
May 25, 2026
Last Updated
April 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.