Clinical trial

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

Active, not recruiting · Phase 2 · 1 countries · Registry ID NCT06851858

Active, not recruitingPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years

SexAll

Healthy volunteersAccepted

ConditionEndocrinology, Diabetes, Type II, Obesity

Full registry criteria

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

Treatments and study arms

AZD6234

Drug

Weekly SC injections of AZD6234

Placebo to match

Drug

Weekly SC injections of matching placebo

Primary outcomes

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

Study locations

18 locations were listed when this page was built. The first 40 are shown.

Research Site🇺🇸 Birmingham, Alabama, United States