360 Participants Needed

AZD9550 + AZD6234 for Obesity

(ASCEND Trial)

Recruiting at 52 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: AstraZeneca
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on a GLP1 medication, you must stop it at least 3 months before joining the trial.

How does the drug AZD9550 + AZD6234 for obesity differ from other treatments?

The drug AZD9550 + AZD6234 for obesity is unique because it combines two components, potentially offering a novel mechanism of action compared to existing treatments. While specific details about its mechanism are not provided, it may involve targeting multiple pathways, similar to other multireceptor agonists like LY3437943, which targets glucagon, GIP, and GLP-1 receptors to manage weight and improve metabolic health.12345

Eligibility Criteria

This trial is for individuals who are overweight or obese and have at least one weight-related health issue. Participants will receive weekly subcutaneous injections and must not be taking other weight loss medications.

Inclusion Criteria

My BMI is 30 or higher, or it's 27 or higher with a weight-related health issue.
A stable, self-reported body weight for 3 months prior to screening
I can sign and understand the consent form.
See 2 more

Exclusion Criteria

I have a history of pancreatitis or my pancreas enzymes are high.
I have serious stomach or liver-related disease.
I have diabetes or symptoms of poor blood sugar control.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AZD9550 and AZD6234 in combination or as monotherapy for weight loss

36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-6 weeks

Treatment Details

Interventions

  • AZD6234
  • AZD9550
Trial Overview The study tests if a combination of two drugs, AZD9550 and AZD6234, given as weekly shots, is more effective for weight loss than placebo or either drug alone in people with obesity or overweight conditions.
Participant Groups
9Treatment groups
Experimental Treatment
Group I: Arm 9Experimental Treatment2 Interventions
AZD6234 high dose or placebo
Group II: Arm 8Experimental Treatment2 Interventions
AZD9550 high dose or placebo
Group III: Arm 7Experimental Treatment3 Interventions
AZD9550 medium dose + AZD6234 high dose or placebos
Group IV: Arm 6Experimental Treatment3 Interventions
AZD9550 high dose + AZD6234 medium dose or placebos
Group V: Arm 5Experimental Treatment3 Interventions
AZD9550 medium dose + AZD6234 low dose or placebos
Group VI: Arm 4Experimental Treatment3 Interventions
AZD9550 low dose + AZD6234 medium dose or placebos
Group VII: Arm 3Experimental Treatment3 Interventions
AZD9550 high dose + AZD6234 high dose or placebos
Group VIII: Arm 2Experimental Treatment3 Interventions
AZD9550 medium dose + AZD6234 medium dose or placebos
Group IX: Arm 1Experimental Treatment3 Interventions
AZD9550 low dose + AZD6234 low dose or placebos

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from ร‰cole nationale vรฉtรฉrinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from ร‰cole nationale vรฉtรฉrinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Findings from Research

In a study of 59 Chinese patients with morbid obesity, 10 individuals were found to have six different mutations in the MC4R gene, with a prevalence of 16.9% among this group, indicating a significant genetic factor in obesity.
Patients with rare MC4R variants, such as R165W and G233S, showed substantial weight loss after metabolic surgery, suggesting that personalized treatment based on genetic variants can enhance surgical outcomes.
Functional Characterization of MC4R Variants in Chinese Morbid Obese Patients and Weight Loss after Bariatric Surgery.Gong, Y., Wu, Q., Huang, S., et al.[2023]
LY3437943 is a novel triple agonist that targets three receptors related to metabolism, showing promising results in obese mice by reducing body weight and improving blood sugar control.
In a phase 1 study, LY3437943 demonstrated a safety profile similar to existing treatments and supported once-weekly dosing, with weight loss effects lasting up to 43 days after a single dose.
LY3437943, a novel triple glucagon, GIP, and GLP-1 receptor agonist for glycemic control and weight loss: From discovery to clinical proof of concept.Coskun, T., Urva, S., Roell, WC., et al.[2022]
In a study of 682 morbidly obese patients who underwent Swedish adjustable gastric band surgery, those with type 2 diabetes mellitus (T2DM) experienced an average excess weight loss of 38% over a median follow-up of 12.5 months, leading to significant improvements in blood sugar levels and hemoglobin A1c.
The study found that 81% of patients on oral hypoglycemic agents saw remission or improvement in their T2DM, with early intervention (less than 5 years of T2DM before surgery) greatly increasing the likelihood of remission. Additionally, no patients with impaired glucose tolerance progressed to diabetes, suggesting potential preventive benefits.
Gastric banding for the treatment of type 2 diabetes mellitus in morbidly obese.Brancatisano, A., Wahlroos, S., Matthews, S., et al.[2011]

References

Functional Characterization of MC4R Variants in Chinese Morbid Obese Patients and Weight Loss after Bariatric Surgery. [2023]
LY3437943, a novel triple glucagon, GIP, and GLP-1 receptor agonist for glycemic control and weight loss: From discovery to clinical proof of concept. [2022]
Gastric banding for the treatment of type 2 diabetes mellitus in morbidly obese. [2011]
A Comparison of New Pharmacological Agents for the Treatment of Obesity. [2018]
Horizons in the Pharmacotherapy of Obesity. [2018]