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Efficacy, Safety and Tolerability of AZD6234 in Participants Living With Overweight or Obesity With Type 2 Diabetes Who Are on a Stable Dose of GLP-1 Receptor Agonist

NCT ID: NCT06851858

Last Updated: 2025-09-11

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

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-12

Study Completion Date

2026-07-08

Brief Summary

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This Phase II study is a randomized, parallel group, double blinded, placebo-controlled, multicenter to evaluate the efficacy, safety, and tolerability of AZD6234 in adults with overweight or obesity and type 2 diabetes on stable GLP-1 RA therapy.

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Detailed Description

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This is a Phase II, randomised, parallel-group, double-blind, placebo-controlled, multi-centre study to assess the efficacy, safety, and tolerability of AZD6234 compared with placebo, given once weekly as a subcutaneous (SC) injection, in adults living with overweight or obesity and type 2 diabetes who are on a stable dose of GLP-1 RA. The study is being conducted across sites in the USA to evaluate the efficacy, safety, and tolerability of AZD6234 in adults with overweight or obesity and type 2 diabetes on stable GLP-1 RA therapy. A total of 64 Participants, aged 18-75 with a BMI ≥ 27 kg/m², will be randomized to receive weekly subcutaneous injections of either AZD6234 or a placebo, alongside their current GLP-1 RA medication. The study involves a screening period and a treatment and follow-up period.

Conditions

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Endocrinology Diabetes, Type II Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

The study spans approx. 37 weeks per participant, including a screening period, a treatment period and a follow-up period. Around 64 eligible participants will be randomized to receive either AZD6234 or a matching placebo, in addition to their stable GLP-1 RA regimen. Treatments consist of weekly subcutaneous injections, with AZD6234 dosing adjustments allowed based on individual tolerance.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
This is a double-blind study in which AstraZeneca, the study site staff, and participants remain blinded during the clinical study. All packaging and labelling of IMP will be done in such a way as to ensure blinding for all participants, AstraZeneca staff, and study site staff. Blinded investigators, blinded study site staff, and participants will remain blinded to each participant's assigned IMP throughout the course of the study.

Study Groups

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AZD6234

Weekly SC injections of AZD6234

Group Type EXPERIMENTAL

AZD6234

Intervention Type DRUG

Weekly SC injections of AZD6234

Placebo for AZD6234

Weekly SC injections of matching placebo

Group Type PLACEBO_COMPARATOR

Placebo to match

Intervention Type DRUG

Weekly SC injections of matching placebo

Interventions

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AZD6234

Weekly SC injections of AZD6234

Intervention Type DRUG

Placebo to match

Weekly SC injections of matching placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Be 18 to 75 years old at the time of signing the informed consent.
2. Diagnosed with type 2 diabetes ≥ 180 days before screening.
3. HbA1c value at screening of ≥ 6.0% (42 mmol/mol) and ≤ 10% (86 mmol/mol).
4. On a stable maintenance dose of an injectable GLP-1 RA.
5. At Screening, have a BMI ≥ 27 kg/m2

Exclusion Criteria

1. Has received treatment with prescription or non-prescription medication for weight loss within the last 3 months prior to screening (other than a GLP-1 RA).
2. Self-reported weight change of \> 5 % in the 3 months prior to screening.
3. Diabetes mellitus that is not clearly type 2 diabetes.
4. Use of insulin therapy for T2DM
5. Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier)
6. Significant hepatobiliary disease (except for non-alcoholic steatohepatitis or nonalcoholic fatty liver disease without portal hypertension or cirrhosis)

8\. Impaired renal function defined as eGFR ≤ 45 mL/minute/1.73m2 at screening
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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

Birmingham, Alabama, United States

Site Status RECRUITING

Research Site

Mobile, Alabama, United States

Site Status RECRUITING

Research Site

Doral, Florida, United States

Site Status RECRUITING

Research Site

Jacksonville, Florida, United States

Site Status RECRUITING

Research Site

Miami, Florida, United States

Site Status RECRUITING

Research Site

Miami, Florida, United States

Site Status RECRUITING

Research Site

Winter Park, Florida, United States

Site Status RECRUITING

Research Site

Canton, Georgia, United States

Site Status RECRUITING

Research Site

Macon, Georgia, United States

Site Status WITHDRAWN

Research Site

Chicago, Illinois, United States

Site Status RECRUITING

Research Site

Oak Brook, Illinois, United States

Site Status RECRUITING

Research Site

Newton, Kansas, United States

Site Status RECRUITING

Research Site

Lexington, Kentucky, United States

Site Status RECRUITING

Research Site

Kansas City, Missouri, United States

Site Status RECRUITING

Research Site

Las Vegas, Nevada, United States

Site Status RECRUITING

Research Site

Norman, Oklahoma, United States

Site Status RECRUITING

Research Site

Knoxville, Tennessee, United States

Site Status RECRUITING

Research Site

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

[email protected]
1-877-240-9479

Other Identifiers

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D8750C00005

Identifier Type: -

Identifier Source: org_study_id

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