Clinical trial NCT06595238: A Study in Participants With Obesity or Overweight With at Least One Weight-related Comorbidity
Official title: A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD6234 in Participants Living With Obesity or Overweight With Comorbidity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Obesity or Overweight
Keywords: Obesity
Overweight
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 262
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: A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD6234 compared with placebo, given once a week as subcutaneous injection for 36 weeks, in male and female participants of at least 18 years of age who are living with obesity (body mass index \[BMI\] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) and at least one weight-related comorbidity

Detailed description: The study will comprise of:

A screening period of maximum 28 days

A treatment period of 36 weeks

A follow up period after last dose of study drug

This study will consist of 4 cohorts. Approximately 231 eligible participants will be randomized to AZD6234 or placebo

Eligibility criteria: Inclusion Criteria:

* Adults ≥ 18 years of age
* BMI of (a) ≥ 30 kg/m2, or (b) ≥ 27kg/m2 and have a current diagnosis of at least 1 weight-related comorbidities (treated or untreated)
* 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 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 T2DM

Primary outcomes:
measure: Percent change in body weight from baseline to week 26
timeFrame: 26 weeks
measure: Weight loss ≥ 5% from baseline weight to week 26
timeFrame: 26 weeks
Secondary outcomes:
measure: Weight loss ≥ 5% from baseline to week 36
timeFrame: 36 weeks
measure: Weight loss ≥ 10% from baseline to week 36
timeFrame: 36 weeks
measure: Percent change in body weight from baseline to week 36
timeFrame: 36 weeks
measure: Absolute change in body weight (kg) from baseline to week 26 and week 36
timeFrame: week 26 and week 36
measure: AZD6234 plasma concentrations
timeFrame: Week 43
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Long Beach
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: Seminole
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Woodstock
country: United States
facility: Research Site
state: Georgia
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Nottingham
country: United States
facility: Research Site
state: Maryland
city: Gulfport
country: United States
facility: Research Site
state: Mississippi
city: Ridgeland
country: United States
facility: Research Site
state: Mississippi
city: Kansas City
country: United States
facility: Research Site
state: Missouri
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Portsmouth
country: United States
facility: Research Site
state: New Hampshire
city: Statesville
country: United States
facility: Research Site
state: North Carolina
city: North Charleston
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: Port Arthur
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Heidelberg West
country: Australia
facility: Research Site
city: Maroochydore
country: Australia
facility: Research Site
city: Maroubra
country: Australia
facility: Research Site
city: Merewether
country: Australia
facility: Research Site
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: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Research Site
state: Quebec
city: Chuo-ku
country: Japan
facility: Research Site
city: Chuo-ku
country: Japan
facility: Research Site
city: Shinjuku-ku
country: Japan
facility: Research Site
city: Suita-shi
country: Japan
facility: Research Site
city: Hull
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: Penarth
country: United Kingdom
facility: Research Site
city: Rotherham
country: United Kingdom
facility: Research Site
Study officials:
References: