Dysautonomia International

A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus

Purpose

The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment

Condition

Obesity or Overweight

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Males & females (inclusive of all gender identities) age ≥18 years - BMI ≥30 kg/m2 OR BMI ≥27 kg/m2 with at least one of the following weight related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction-associated steatotic liver disease, osteoarthritis of the knee, or stress urinary incontinence - Stable body weight (≤5% body weight change) for at least 3 months prior to Randomisation - History of at least one self-reported unsuccessful attempt to lose body weight in their lifetime

Exclusion Criteria

Obesity primarily caused by other endocrine disorders - History of Type 1 or Type 2 Diabetes Mellitus, HbA1c ≥6.5% (48 mmol/mol), and/or treatment with glucose-lowering agent(s) within 3 months prior to Screening - Significant hepatobiliary disease and/or any of the following results at Screening: - ALT ≥ 3.0 × ULN - AST ≥ 3.0 × ULN - TBL > 1.5 × ULN (except for cases of known Gilbert's Syndrome) - Has received treatment with a GLP-1 receptor agonist or GLP-1 containing medication for any indication within 3 months before Randomisation.

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: International, multi-centre, randomised, double-blind, placebo-controlled, parallel-group
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental AZD6234 Dose 1	AZD6234 Dose 1	Drug: AZD6234 IMP injected subcutaneously, once a week. Unit dose strength as per CSP.
Experimental AZD6234 Dose 2	AZD6234 Dose 2	Drug: AZD6234 IMP injected subcutaneously, once a week. Unit dose strength as per CSP.
Placebo Comparator Placebo	Matching placebo	Drug: Placebo Placebo matching IMP dose injected subcutaneously, once a week.

More Details

Status: Recruiting
Sponsor: AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Detailed Description

This is a Phase III, global, randomised, parallel-group, double-blind, multicentre study to assess the efficacy and safety of AZD6234 compared with placebo, administered SC once weekly in adults with obesity or overweight with at least one weight-related comorbidity without T2DM. Eligible participants will be randomized to either receive AZD6234 or matching placebo respectively.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.