Weight loss treatment using AZD9550 and AZD6234
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)
This study is testing a new combination of weight loss medications, AZD9550 and AZD6234, to see if they help adults with obesity and related health issues lose weight better than a placebo or each drug alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 62 sites (Centreville, Alabama and 61 other locations) |
| Trial ID | NCT06862791 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of AZD9550 combined with AZD6234 compared to placebo and each drug alone for weight loss in adults with obesity or overweight and at least one weight-related co-morbidity. It is a Phase IIb, global, randomized, double-blind, placebo-controlled trial involving approximately 360 participants across 60 sites in 7 countries. Participants will undergo a screening period, a treatment period, and a follow-up period lasting about 47 weeks to assess the safety, efficacy, and tolerability of the treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a BMI of 30 or higher, or 27 or higher with a weight-related co-morbidity.
Not a fit: Patients with a history of clinically important diseases, gastrointestinal, renal, or hepatic disorders, or those who have undergone bariatric surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for weight loss in individuals struggling with obesity and related health issues.
How similar studies have performed: Other studies have shown promise in using combination therapies for weight loss, but this specific combination is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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. 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
Where this trial is running
Centreville, Alabama and 61 other locations
- Research Site — Centreville, Alabama, United States (Not_yet_recruiting)
- Research Site — Dothan, Alabama, United States (Recruiting)
- Research Site — Vestavia Hills, Alabama, United States (Recruiting)
- Research Site — Cerritos, California, United States (Recruiting)
- Research Site — Escondido, California, United States (Recruiting)
- Research Site — Huntington Park, California, United States (Recruiting)
- Research Site — Lincoln, California, United States (Recruiting)
- Research Site — Sacramento, California, United States (Recruiting)
- Research Site — Englewood, Colorado, United States (Not_yet_recruiting)
- Research Site — Waterbury, Connecticut, United States (Recruiting)
- Research Site — Palm Harbor, Florida, United States (Recruiting)
- Research Site — Decatur, Georgia, United States (Recruiting)
- Research Site — Stockbridge, Georgia, United States (Recruiting)
- Research Site — Meridian, Idaho, United States (Withdrawn)
- Research Site — Champaign, Illinois, United States (Recruiting)
- Research Site — South Bend, Indiana, United States (Recruiting)
- Research Site — Valparaiso, Indiana, United States (Recruiting)
- Research Site — Sioux City, Iowa, United States (Recruiting)
- Research Site — Overland Park, Kansas, United States (Withdrawn)
- Research Site — Rockville, Maryland, United States (Withdrawn)
- Research Site — Southfield, Michigan, United States (Recruiting)
- Research Site — Saint Louis, Missouri, United States (Withdrawn)
- Research Site — Missoula, Montana, United States (Recruiting)
- Research Site — Omaha, Nebraska, United States (Recruiting)
- Research Site — Albuquerque, New Mexico, United States (Recruiting)
- Research Site — Binghamton, New York, United States (Withdrawn)
- Research Site — Fargo, North Dakota, United States (Recruiting)
- Research Site — Cincinnati, Ohio, United States (Recruiting)
- Research Site — Columbus, Ohio, United States (Recruiting)
- Research Site — Tulsa, Oklahoma, United States (Recruiting)
- Research Site — Medford, Oregon, United States (Recruiting)
- Research Site — Kingsport, Tennessee, United States (Recruiting)
- Research Site — Brownsville, Texas, United States (Recruiting)
- Research Site — Houston, Texas, United States (Recruiting)
- Research Site — Arlington, Virginia, United States (Recruiting)
- Research Site — Renton, Washington, United States (Recruiting)
- Research Site — Maroochydore, Australia (Recruiting)
- Research Site — Maroubra, Australia (Recruiting)
- Research Site — Norwood, Australia (Recruiting)
- Research Site — St Albans, Australia (Recruiting)
- Research Site — St Leonards, Australia (Recruiting)
- Research Site — Calgary, Alberta, Canada (Recruiting)
- Research Site — Surrey, British Columbia, Canada (Recruiting)
- Research Site — Guelph, Ontario, Canada (Recruiting)
- Research Site — Hamilton, Ontario, Canada (Recruiting)
- Research Site — Hamilton, Ontario, Canada (Recruiting)
- Research Site — Sarnia, Ontario, Canada (Recruiting)
- Research Site — Stouffville, Ontario, Canada (Recruiting)
- Research Site — Montreal, Quebec, Canada (Recruiting)
- Research Site — Berlin, Germany (Recruiting)
+12 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.