NCT06862791

A Weight Loss Study Evaluating Subcutaneous Treatment With AZD9550 and AZD6234 in Combination Against Placebo or Each of the Drugs Alone

A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of Co-administration of AZD9550 and AZD6234 in Participants Living With Obesity or Overweight With Co-morbidity (ASCEND)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 377 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether treatment with AZD9550 when given in combination with AZD6234 as once weekly subcutaneous (SC) injections is superior to placebo or either agent administered as monotherapy for weight loss in participants living with obesity or overweight with at least one weight-related co-morbidity.

Detailed description

This is a Phase IIb, global, randomised, parallel-group, double-blind, placebo-controlled, multi-centre, reduced factorial study designed to evaluate the efficacy, safety and tolerability of treatment with AZD9550 and AZD6234 in combination or as monotherapy in adults who are living with obesity or overweight with at least one of the following weight-related co-morbidities: hypertension, dyslipidemia or obstructive sleep apnoea. The study is composed of a screening period, a treatment period and a follow up period with participants expected to be in the study for approximately 47 weeks. The study will be conducted at around 60 sites and in approximately 7 countries with about, 360 participants will be randomly assigned to study intervention or placebo.

Conditions

• Obesity or Overweight

Interventions

Type	Name	Description
DRUG	AZD9550	IMP injected subcutaneous, once weekly. Unit dose strength as per CSP
DRUG	AZD6234	IMP injected subcutaneous, once weekly. Unit dose strength as per CSP.
DRUG	Placebo comparator	Placebo matching IMP dose injected subcutaneously, once weekly.

Timeline

• Start date: 2025-02-18
• Primary completion: 2026-05-25
• Completion: 2026-05-25
• First posted: 2025-03-06
• Last updated: 2026-02-02

Locations

53 sites across 5 countries: United States, Australia, Canada, Germany, Japan

Regulatory

• FDA-regulated drug study