ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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)

Quick Facts

Study Start:2025-02-18
Study Completion:2026-06-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06862791

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant must be 18 to 75 years of age inclusive.
  2. * BMI: ≥ 30 kg/m2, or ≥ 27 kg/m2 with at least one weight related comorbidity.
  3. * A stable, self-reported body weight for 3 months prior to screening.
  4. * 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.
  5. * Female participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline.
  6. * Capable of giving signed informed consent.
  1. * History of any clinically important disease or disorder, which, in the opinion of the Investigator, may put the participant at risk.
  2. * History or presence of GI, renal, hepatic disease.
  3. * Previous or planned bariatric surgery or fitting of a weight loss device.
  4. * Obesity induced by endocrine disorders such as Cushing's syndrome, insulinoma or Prader-Willi syndrome.
  5. * History of T1DM or T2DM or symptoms indicative of insulinopenia or poor glucose control.
  6. * 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).
  7. * Significant gastric and hepatobiliary disease.
  8. * History of acute or chronic pancreatitis or pancreatic amylase or lipase \> 2 × ULN at screening.
  9. * History of psychosis or bipolar disorder.
  10. * History of major depressive disorder within the 2 years prior to screening or depression.
  11. * 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.
  12. * Vulnerable populations

Contacts and Locations

Study Locations (Sites)

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
Research Site
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
Research Site
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

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-18
Study Completion Date2026-06-18

Study Record Updates

Study Start Date2025-02-18
Study Completion Date2026-06-18

Terms related to this study

Keywords Provided by Researchers

  • Obesity
  • Overweight
  • AZD9550
  • AZD6234

Additional Relevant MeSH Terms

  • Obesity or Overweight