A Study in Participants With Obesity or Overweight With at Least One Weight-related Comorbidity

NCT ID: NCT06595238

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

262 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-12-03

Brief Summary

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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

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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

Conditions

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Obesity or Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1

Dose 1

Group Type EXPERIMENTAL

AZD6234

Intervention Type DRUG

IMP injected subcutaneously, once a week. Unit dose strength as per CSP

Arm 2

Dose 2

Group Type EXPERIMENTAL

AZD6234

Intervention Type DRUG

IMP injected subcutaneously, once a week. Unit dose strength as per CSP

Arm 3

Dose 3

Group Type EXPERIMENTAL

AZD6234

Intervention Type DRUG

IMP injected subcutaneously, once a week. Unit dose strength as per CSP

Arm 4

Placebo - Dose matched with each Experimental arm

Group Type PLACEBO_COMPARATOR

Placebo comparator

Intervention Type DRUG

Placebo matching IMP dose injected subcutaneously, once a week.

Interventions

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AZD6234

IMP injected subcutaneously, once a week. Unit dose strength as per CSP

Intervention Type DRUG

Placebo comparator

Placebo matching IMP dose injected subcutaneously, once a week.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Long Beach, California, United States

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Hialeah, Florida, United States

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Largo, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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Woodstock, Georgia, United States

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Indianapolis, Indiana, United States

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Lutherville-Timonium, Maryland, United States

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Gulfport, Mississippi, United States

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Ridgeland, Mississippi, United States

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Kansas City, Missouri, United States

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Omaha, Nebraska, United States

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Portsmouth, New Hampshire, United States

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Statesville, North Carolina, United States

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North Charleston, South Carolina, United States

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Knoxville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Port Arthur, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Heidelberg, , Australia

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Maroochydore, , Australia

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Maroubra, , Australia

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Merewether, , Australia

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Hamilton, Ontario, Canada

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Sarnia, Ontario, Canada

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Stouffville, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Chūōku, , Japan

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Chūōku, , Japan

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Shinjuku-ku, , Japan

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Suita-shi, , Japan

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Hull, , United Kingdom

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Leicester, , United Kingdom

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Penarth, , United Kingdom

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Rotherham, , United Kingdom

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Countries

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United States Australia Canada Japan United Kingdom

Other Identifiers

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2024-514000-13-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

D8750C00004

Identifier Type: -

Identifier Source: org_study_id