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

NCT06851858 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: D8750C00005
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

Diabetes, Type II; Obesity; Endocrinology

Keywords

Diabetes, Type II; Obesity

Outcome Measures

Primary Outcomes (2)

• Percent change in body weight from baseline at Study Week 26

  To determine whether treatment with AZD6234 is superior to placebo for weight loss at Study Week 26

  From baseline to week 26

• Weight loss ≥ 5% from baseline at Study Week 26

  To assess the effect of AZD6234 versus placebo on the proportion of participants with weight loss ≥ 5% from baseline at Study Week 26

  From baseline to week 26

Secondary Outcomes (5)

• Weight loss ≥ 10% from baseline at Study Week 26

  From baseline to week 26

• Absolute change in body weight (kg) from baseline at Study Week 26

  From baseline to week 26

• Change in HbA1c from baseline at Study Week 26.

  From baseline to week 26

• AZD6234 plasma concentrations

  From baseline to week 26

• Change in serum glucose from baseline at Study Week 26.

  From baseline to week 26

Study Arms (2)

AZD6234

EXPERIMENTAL

Weekly SC injections of AZD6234

Drug: AZD6234

Placebo for AZD6234

PLACEBO COMPARATOR

Weekly SC injections of matching placebo

Drug: Placebo to match

Interventions

AZD6234 DRUG

Weekly SC injections of AZD6234

AZD6234

Placebo to match DRUG

Weekly SC injections of matching placebo

Placebo for AZD6234

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).
• Self-reported weight change of \> 5 % in the 3 months prior to screening.
• Diabetes mellitus that is not clearly type 2 diabetes.
• Use of insulin therapy for T2DM
• Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier)
• Significant hepatobiliary disease (except for non-alcoholic steatohepatitis or nonalcoholic fatty liver disease without portal hypertension or cirrhosis)
• \. Impaired renal function defined as eGFR ≤ 45 mL/minute/1.73m2 at screening

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (18)

Research Site

Birmingham, Alabama, 35205, United States

Location

Research Site

Mobile, Alabama, 36608, United States

Location

Research Site

Doral, Florida, 33166, United States

Location

Research Site

Jacksonville, Florida, 32216, United States

Location

Research Site

Miami, Florida, 33135, United States

Location

Research Site

Miami, Florida, 33136, United States

Location

Research Site

Winter Park, Florida, 32789, United States

Location

Research Site

Canton, Georgia, 30114, United States

Location

Research Site

Fayetteville, Georgia, 30214, United States

Location

Research Site

Chicago, Illinois, 60640, United States

Location

Research Site

Oak Brook, Illinois, 60523, United States

Location

Research Site

Newton, Kansas, 67114, United States

Location

Research Site

Lexington, Kentucky, 40509, United States

Location

Research Site

Kansas City, Missouri, 64114, United States

Location

Research Site

Las Vegas, Nevada, 89119, United States

Location

Research Site

Norman, Oklahoma, 73069, United States

Location

Research Site

Knoxville, Tennessee, 37909, United States

Location

Research Site

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This study will be conducted as double-blind through its duration, with participants, investigators, and site staff remaining blinded to treatment allocation. At the time of the interim analysis, Sponsor and designated CRO staff will be unblinded to treatment allocations solely for statistical analysis or operational management. Investigators, site staff, and participants will remain blinded for the entire study duration.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 28, 2025
• Study Start: March 12, 2025
• Primary Completion (Estimated): May 27, 2026
• Study Completion (Estimated): May 27, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (18)