Clinical trial NCT06862791: A Weight Loss Study Evaluating Subcutaneous Treatment With AZD9550 and AZD6234 in Combination Against Placebo or Each of the Drugs Alone
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Obesity or Overweight
Keywords: Obesity
Overweight
AZD9550
AZD6234
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2025-03-06
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 sleep apnoea. The study is composed of a screening period, a treatment period and a follow up period with participants expected to be in the study for approximately 47 weeks. The study will be conducted at around 60 sites and in approximately 7 countries with about, 360 participants will be randomly assigned to study intervention or placebo.

Eligibility 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

Primary outcomes:
measure: Percent change in body weight from baseline after 36 weeks of treatment
timeFrame: 36 weeks
measure: Weight loss ≥ 5% from baseline after 36 weeks of treatment
timeFrame: 36 weeks
Secondary outcomes:
measure: Absolute change in body weight from baseline after 36 weeks of treatment
timeFrame: 36 weeks
measure: Absolute change in body weight from baseline after 36 weeks of treatment
timeFrame: 36 weeks
measure: Weight loss ≥ 5% from baseline after 36 weeks of treatment
timeFrame: 36 weeks
measure: Weight loss ≥ 10% and ≥ 15% from baseline after 36 weeks of treatment
timeFrame: 36 weeks
measure: Prevalence of ADAs to AZD9550 and AZD6234 in combination and as monotherapies after 36 weeks of treatment
timeFrame: 36 weeks
measure: Incidence of ADAs to AZD9550 and AZD6234 in combination and as monotherapies after 36 weeks of treatment
timeFrame: 36 weeks
measure: Titres of ADAs to AZD9550 and AZD6234 in combination and as monotherapies after 36 weeks of treatment
timeFrame: 36 weeks
measure: Percent change in body weight from baseline after 36 weeks of treatment
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Centreville
country: United States
facility: Research Site
state: Alabama
city: Dothan
country: United States
facility: Research Site
state: Alabama
city: Vestavia Hills
country: United States
facility: Research Site
state: Alabama
city: Cerritos
country: United States
facility: Research Site
state: California
city: Escondido
country: United States
facility: Research Site
state: California
city: Huntington Park
country: United States
facility: Research Site
state: California
city: Lincoln
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: Englewood
country: United States
facility: Research Site
state: Colorado
city: Waterbury
country: United States
facility: Research Site
state: Connecticut
city: Palm Harbor
country: United States
facility: Research Site
state: Florida
city: Decatur
country: United States
facility: Research Site
state: Georgia
city: Stockbridge
country: United States
facility: Research Site
state: Georgia
city: Meridian
country: United States
facility: Research Site
state: Idaho
city: Champaign
country: United States
facility: Research Site
state: Illinois
city: South Bend
country: United States
facility: Research Site
state: Indiana
city: Valparaiso
country: United States
facility: Research Site
state: Indiana
city: Sioux City
country: United States
facility: Research Site
state: Iowa
city: Overland Park
country: United States
facility: Research Site
state: Kansas
city: Rockville
country: United States
facility: Research Site
state: Maryland
city: Southfield
country: United States
facility: Research Site
state: Michigan
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Missoula
country: United States
facility: Research Site
state: Montana
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Binghamton
country: United States
facility: Research Site
state: New York
city: Fargo
country: United States
facility: Research Site
state: North Dakota
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Tulsa
country: United States
facility: Research Site
state: Oklahoma
city: Medford
country: United States
facility: Research Site
state: Oregon
city: Kingsport
country: United States
facility: Research Site
state: Tennessee
city: Brownsville
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Arlington
country: United States
facility: Research Site
state: Virginia
city: Renton
country: United States
facility: Research Site
state: Washington
city: Maroochydore
country: Australia
facility: Research Site
city: Maroubra
country: Australia
facility: Research Site
city: Norwood
country: Australia
facility: Research Site
city: St Albans
country: Australia
facility: Research Site
city: St Leonards
country: Australia
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Surrey
country: Canada
facility: Research Site
state: British Columbia
city: Guelph
country: Canada
facility: Research Site
state: Ontario
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Sarnia
country: Canada
facility: Research Site
state: Ontario
city: Stouffville
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Berlin
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Falkensee
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: Muenster
country: Germany
facility: Research Site
city: Oldenburg
country: Germany
facility: Research Site
city: Chuo-ku
country: Japan
facility: Research Site
city: Chuo-ku
country: Japan
facility: Research Site
city: Fukuoka-shi
country: Japan
facility: Research Site
city: Shinjuku-ku
country: Japan
facility: Research Site
city: Suita-shi
country: Japan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
Study officials:
References: