Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT06862791 (ASCEND) for Obesity or Overweight is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Back to Search
AstraZenecaA Weight Loss Study Evaluating Subcutaneous Treatment With AZD9550 and AZD6234 in Combination Against Placebo or Each of the Drugs Alone (ASCEND) Phase 2 377
Clinical Trial NCT06862791 (ASCEND) is designed to study Treatment for Obesity or Overweight. It is a Phase 2 interventional study that is active, not recruiting, having started on 18 February 2025, with plans to enroll 377 participants. Led by AstraZeneca, it is expected to complete by 25 May 2026. The latest data from ClinicalTrials.gov was last updated on 2 February 2026.
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.
Detailed Description
This is a Phase IIb, global, randomised, parallel-group, double-blind, placebo-controlled, multi-centre, reduced factorial study designed to evaluate the efficacy, safety and tolerability of treatment with AZD9550 and AZD6234 in combination or as monotherapy in adults who are living with obesity or overweight with at least one of the following weight-related co-morbidities: hypertension, dyslipidemia or obstructive s...Show More
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)
Conditions
Obesity or OverweightOther Study IDs
- ASCEND
- D8460C00004
- 2024-516176-15-00 (Registry Identifier) (EU CT number)
NCT ID Number
Start Date (Actual)
2025-02-18
Last Update Posted
2026-02-02
Completion Date (Estimated)
2026-05-25
Enrollment (Estimated)
377
Study Type
Interventional
PHASE
Phase 2
Status
Active, not recruiting
Keywords
Obesity
Overweight
AZD9550
AZD6234
Overweight
AZD9550
AZD6234
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalArm 1 AZD9550 low dose + AZD6234 low dose or placebos | AZD9550 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP AZD6234 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP. Placebo comparator Placebo matching IMP dose injected subcutaneously, once weekly. |
ExperimentalArm 2 AZD9550 medium dose + AZD6234 medium dose or placebos | AZD9550 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP AZD6234 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP. Placebo comparator Placebo matching IMP dose injected subcutaneously, once weekly. |
ExperimentalArm 3 AZD9550 high dose + AZD6234 high dose or placebos | AZD9550 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP AZD6234 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP. Placebo comparator Placebo matching IMP dose injected subcutaneously, once weekly. |
ExperimentalArm 4 AZD9550 low dose + AZD6234 medium dose or placebos | AZD9550 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP AZD6234 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP. Placebo comparator Placebo matching IMP dose injected subcutaneously, once weekly. |
ExperimentalArm 5 AZD9550 medium dose + AZD6234 low dose or placebos | AZD9550 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP AZD6234 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP. Placebo comparator Placebo matching IMP dose injected subcutaneously, once weekly. |
ExperimentalArm 6 AZD9550 high dose + AZD6234 medium dose or placebos | AZD9550 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP AZD6234 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP. Placebo comparator Placebo matching IMP dose injected subcutaneously, once weekly. |
ExperimentalArm 7 AZD9550 medium dose + AZD6234 high dose or placebos | AZD9550 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP AZD6234 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP. Placebo comparator Placebo matching IMP dose injected subcutaneously, once weekly. |
ExperimentalArm 8 AZD9550 high dose or placebo | AZD9550 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP Placebo comparator Placebo matching IMP dose injected subcutaneously, once weekly. |
ExperimentalArm 9 AZD6234 high dose or placebo | AZD6234 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP. Placebo comparator Placebo matching IMP dose injected subcutaneously, once weekly. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Absolute 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 |
Absolute change in body weight from baseline after 36 weeks of treatment | To determine whether treatment with AZD9550 and AZD6234 in combination is superior to AZD9550 and AZD6234 monotherapy, and whether AZD9550 and AZD6234 as monotherapies are 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 monotherapy, and assess the effect of AZD9550 and AZD6234 as monotherapies vs placebo, on the proportion of participants with weight loss ≥ 5% | 36 weeks |
Weight loss ≥ 10% and ≥ 15% from baseline after 36 weeks of treatment | To assess the effect of treatment with AZD9550 and AZD6234 in combination vs placebo and monotherapy, and assess the effect of AZD9550 and AZD6234 as monotherapies vs placebo, on the proportion of participants with weight loss ≥ 10% and ≥ 15% | 36 weeks |
Prevalence of ADAs to AZD9550 and AZD6234 in combination and as monotherapies after 36 weeks of treatment | To assess the immunogenicity profile of treatment with AZD9550 and AZD6234 in combination and as monotherapies | 36 weeks |
Incidence of ADAs to AZD9550 and AZD6234 in combination and as monotherapies after 36 weeks of treatment | To assess immunogenicity profile of ADAs to AZD9550 and AZD6234 in combination and as monotherapies | 36 weeks |
Titres of ADAs to AZD9550 and AZD6234 in combination and as monotherapies after 36 weeks of treatment | To assess the immunogenicity profile of treatment with AZD9550 and AZD6234 in combination and as monotherapies | 36 weeks |
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 AZD9550 and AZD6234 monotherapy, and whether AZD9550 and AZD6234 as monotherapies are superior to placebo for weight loss | 36 weeks |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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
AstraZeneca772 active studies to exploreNo contact data.
53 Study Locations in 5 Countries
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
Alabama
Research Site, Dothan, Alabama, 36305, United States
Research Site, Vestavia Hills, Alabama, 35216, United States
California
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
Connecticut
Research Site, Waterbury, Connecticut, 06708, United States
Florida
Research Site, Palm Harbor, Florida, 34684, United States
Georgia
Research Site, Decatur, Georgia, 30030, United States
Research Site, Stockbridge, Georgia, 30281, United States
Illinois
Research Site, Champaign, Illinois, 61822, United States
Indiana
Research Site, South Bend, Indiana, 46617, United States
Research Site, Valparaiso, Indiana, 46383, United States
Iowa
Research Site, Sioux City, Iowa, 51106, United States
Michigan
Research Site, Southfield, Michigan, 48034, United States
Montana
Research Site, Missoula, Montana, 59804, United States
Nebraska
Research Site, Omaha, Nebraska, 68114, United States
New Mexico
Research Site, Albuquerque, New Mexico, 87107, United States
North Dakota
Research Site, Fargo, North Dakota, 58104, United States
Ohio
Research Site, Cincinnati, Ohio, 45219, United States
Research Site, Columbus, Ohio, 43213, United States
Oklahoma
Research Site, Tulsa, Oklahoma, 74133, United States
Oregon
Research Site, Medford, Oregon, 97504, United States
Tennessee
Research Site, Kingsport, Tennessee, 37660, United States
Texas
Research Site, Brownsville, Texas, 78526, United States
Research Site, Houston, Texas, 77043, United States
Virginia
Research Site, Arlington, Virginia, 22206, United States
Washington
Research Site, Renton, Washington, 98057, United States
Alberta
Research Site, Calgary, Alberta, T2V 4J2, Canada
British Columbia
Research Site, Surrey, British Columbia, V3T 2V6, Canada
Ontario
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
Quebec
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