ASCEND

Active not recruitingPhase 2

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

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)

Lead sponsor

AstraZeneca

Assets

AZD6234 / AZD9550

Listed sites

Recruiting sites

—

Enrollment

377

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoints

•Body weight from baseline after 36 weeks of treatment•Weight loss ≥ 5% from baseline after 36 weeks of treatment

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06862791

Org study IDD8460C00004

Secondary ID2024-516176-15-00EU CT number

Timeline

Milestones

Study start2025-02-18actual

Study first posted2025-03-06actual

Last update posted2026-04-28actual

Primary completion2026-05-25estimated

Study completion2026-05-25estimated

Assets

Investigational agents

AZD6234 AZD9550

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Other (unclassified)

Other clinical outcomes

Weight & body composition

7 endpoints

Primary/protocol endpoint

Percent change in body weight from baseline after 36 weeks of treatment

Time frame:36 weeks

percent change from baseline, improvement

Primary/protocol endpoint

Weight loss ≥ 5% from baseline after 36 weeks of treatment

Time frame:36 weeks

threshold achievement, improvement

Secondary/protocol endpoint

Absolute change in body weight from baseline after 36 weeks of treatment

Time frame:36 weeks

change from baseline, improvement

Secondary/protocol endpoint

Absolute change in body weight from baseline after 36 weeks of treatment

Time frame:36 weeks

change from baseline, improvement

Secondary/protocol endpoint

Weight loss ≥ 5% from baseline after 36 weeks of treatment

Time frame:36 weeks

threshold achievement, improvement

Secondary/protocol endpoint

Weight loss ≥ 10% and ≥ 15% from baseline after 36 weeks of treatment

Time frame:36 weeks

threshold achievement, improvement

Secondary/protocol endpoint

Percent change in body weight from baseline after 36 weeks of treatment

Time frame:36 weeks

percent change from baseline, improvement

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Incidence of ADAs to AZD9550 and AZD6234 in combination and as monotherapies after 36 weeks of treatment

Time frame:36 weeks

event count, event

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Prevalence of ADAs to AZD9550 and AZD6234 in combination and as monotherapies after 36 weeks of treatment

Time frame:36 weeks

descriptive

Secondary/protocol endpoint/low confidence

Titres of ADAs to AZD9550 and AZD6234 in combination and as monotherapies after 36 weeks of treatment

Time frame:36 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.