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

Phase 2

Recruiting

• Conditions: Endocrinology; Diabetes, Type II; Obesity
• Interventions: Drug: Placebo to match; Drug: AZD6234

• Registration Number: NCT06851858
• Lead Sponsor: AstraZeneca

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-24
• Study First Posted: 2025-02-28
• Study Start: 2025-03-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Primary Completion: 2026-01-27
• Study Completion: 2026-01-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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 ≥ 7.0% (53 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)

7. Impaired renal function defined as eGFR ≤ 45 mL/minute/1.73m2 at screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo for AZD6234	Placebo to match	Weekly SC injections of matching placebo
AZD6234	AZD6234	Weekly SC injections of AZD6234

Primary Outcome Measures

Name	Time	Method
Percent change in body weight from baseline at Study Week 26	From baseline to week 26	To determine whether treatment with AZD6234 is superior to placebo for weight loss at Study Week 26
Weight loss ≥ 5% from baseline at Study Week 26	From baseline to 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

Secondary Outcome Measures

Name	Time	Method
Weight loss ≥ 10% from baseline at Study Week 26	From baseline to week 26	To assess the effect of AZD6234 versus placebo on the proportion of participants with weight loss ≥ 10% from baseline at Study Week 26
Absolute change in body weight (kg) from baseline at Study Week 26	From baseline to week 26	To determine whether AZD6234 is superior to placebo for absolute weight reduction (kg) at Study Week 26
Change in HbA1c from baseline at Study Week 26.	From baseline to week 26	To assess the effect of AZD6234 versus placebo on glycaemic control at Study week 26
AZD6234 plasma concentrations	From baseline to week 26	To characterise the PK of AZD6234
Change in serum glucose from baseline at Study Week 26.	From baseline to week 26	To assess the effect of AZD6234 versus placebo on glycaemic control at Study week 26

Trial Locations

Locations (1)

Research Site; 🇺🇸 San Antonio, Texas, United States