Clinical trial NCT06579092: Effects of AZD5004 in Adults Who Are Living With Obesity or Overweight With at Least 1 Weight-related Comorbidity
Official title: A Phase IIb Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD5004 in Participants Living With Obesity or Overweight With Comorbidity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Obesity or Overweight
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-08-30
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase IIb, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of AZD5004 compared with placebo, given once daily as an oral tablet(s) for 36 weeks, in male and female participants at least 18 years of age who are living with obesity (body mass index \[BMI\] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) who have at least 1 weight-related comorbidity

Detailed description: This is a Phase IIb, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of 5 doses of AZD5004 compared with placebo, given once daily as an oral tablet or tablets for a duration of 36 weeks, in adults aged 18 years and above, who are living with obesity (BMI ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) and have at least 1 weight-related comorbidity (Hypertension, Dyslipidemia or hyperlipidemia, CV disease and/or Obstructive sleep apnea). Approximately 304 participants will be randomized in the study. The dual primary endpoints are percent change in body weight from baseline at 26 weeks and the proportion of participants with weight loss ≥ 5% of baseline weight at 26 weeks.

Eligibility criteria: Inclusion Criteria:

* Adults ≥ 18 years of age.
* BMI of (a) ≥ 30 kg/m2, or (b) ≥ 27 kg/m2 and have a current diagnosis of at least 1 of the following weight-related comorbidities (treated or untreated):

  (i) Hypertension (ii) Dyslipidemia or hyperlipidemia (iii) CV disease (iv) Obstructive sleep apnea
* A stable body weight for 3 months prior to Screening (± 5% body weight change).

Exclusion Criteria:

* Have obesity induced by other endocrine disorders, such as Cushing's syndrome or monogenic or syndromic obesity such as Prader-Willi syndrome.
* Has received prescription or non-prescription medication for weight loss within the last 3 months prior to Screening.
* Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier).
* History of type 1 diabetes mellitus or type 2 diabetes mellitus.
* Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract.
* History of acute or chronic pancreatitis.

Primary outcomes:
measure: Percent change in body weight from baseline
timeFrame: 26 weeks
measure: Proportion of participants with weight loss ≥ 5% from baseline weight
timeFrame: 26 weeks
Secondary outcomes:
measure: Percent change in body weight from baseline
timeFrame: 36 weeks
measure: Proportion of participants with weight loss ≥ 5%
timeFrame: 36 weeks
measure: Absolute change from baseline in body weight
timeFrame: Week 26 and Week 36
measure: Proportion of participants with weight loss ≥ 10% as well as ≥ 15%
timeFrame: Week 26 and Week 36
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Research Site
state: Arizona
city: Huntington Park
country: United States
facility: Research Site
state: California
city: La Mesa
country: United States
facility: Research Site
state: California
city: Lincoln
country: United States
facility: Research Site
state: California
city: Walnut Creek
country: United States
facility: Research Site
state: California
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Lombard
country: United States
facility: Research Site
state: Illinois
city: Valparaiso
country: United States
facility: Research Site
state: Indiana
city: West Des Moines
country: United States
facility: Research Site
state: Iowa
city: Roslindale
country: United States
facility: Research Site
state: Massachusetts
city: Farmington Hills
country: United States
facility: Research Site
state: Michigan
city: Chesterfield
country: United States
facility: Research Site
state: Missouri
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Vestal
country: United States
facility: Research Site
state: New York
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Wilmington
country: United States
facility: Research Site
state: North Carolina
city: Fargo
country: United States
facility: Research Site
state: North Dakota
city: Beachwood
country: United States
facility: Research Site
state: Ohio
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: North Charleston
country: United States
facility: Research Site
state: South Carolina
city: Spartanburg
country: United States
facility: Research Site
state: South Carolina
city: Knoxville
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Woodway
country: United States
facility: Research Site
state: Texas
city: Ogden
country: United States
facility: Research Site
state: Utah
city: Charlottesville
country: United States
facility: Research Site
state: Virginia
city: Manassas
country: United States
facility: Research Site
state: Virginia
city: Heidelberg West
country: Australia
facility: Research Site
city: Merewether
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: Victoria
country: Canada
facility: Research Site
state: British Columbia
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
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: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Terrebonne
country: Canada
facility: Research Site
state: Quebec
city: Bad Oeynhausen
country: Germany
facility: Research Site
city: Berlin
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: Sankt Ingbert
country: Germany
facility: Research Site
city: Suita-shi
country: Japan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Blackpool
country: United Kingdom
facility: Research Site
city: Bristol
country: United Kingdom
facility: Research Site
city: Chesterfield
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: Rotherham
country: United Kingdom
facility: Research Site
city: Witney
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Diabetes Research Centre Leicester Diabetes Centre - Bloom University of Leicester
name: Prof Melanie Davies, MBChB MD
role: PRINCIPAL_INVESTIGATOR
References: