AZD5004 for Obesity

(VISTA Trial)

Recruiting in Palo Alto (17 mi)

+62 other locations

Overseen by Prof Melanie Davies, MBChB MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AstraZeneca

Must not be taking: Weight loss drugs

Disqualifiers: Diabetes, Cushing's, Prader-Willi, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

A Phase IIb, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of AZD5004 compared with placebo, given once daily as an oral tablet(s) for 36 weeks, in male and female participants at least 18 years of age who are living with obesity (body mass index \[BMI\] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) who have at least 1 weight-related comorbidity

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have taken any weight loss medications in the last 3 months before the study.

How does the drug AZD5004 differ from other obesity treatments?

AZD5004 is unique because it may target the melanocortin-4 receptor (MC4R), which plays a key role in regulating body weight by affecting energy balance. This approach could be particularly beneficial for individuals with specific genetic variations in the MC4R gene, offering a more personalized treatment option compared to standard obesity therapies. ^{1 2 3 4 5}

Research Team

Prof Melanie Davies, MBChB MD

Principal Investigator

Diabetes Research Centre Leicester Diabetes Centre - Bloom University of Leicester

Eligibility Criteria

This trial is for adults at least 18 years old who are living with obesity (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) with at least one weight-related health issue. Key eligibility details will be provided by the study team.

Inclusion Criteria

I am 18 years old or older.

A stable body weight for 3 months prior to Screening (± 5% body weight change)

My BMI is over 27 and I have a condition like high blood pressure, high cholesterol, heart disease, or sleep apnea.

Exclusion Criteria

I have a history of type 1 or type 2 diabetes.

I have a history of pancreatitis.

I have a severe digestive condition or have had major surgery on my upper GI tract.

Treatment Details

Interventions

• AZD5004 (Other)

Trial Overview The trial is testing AZD5004, a new oral medication, against a placebo over a period of 36 weeks to see its effects on individuals with obesity or overweight conditions. Participants are randomly assigned to either the drug or placebo group.

Participant Groups

Group I: Arm 5 Experimental Treatment 1 Intervention

Active IMP

Group II: Arm 4 Experimental Treatment 1 Intervention

Active IMP

Group III: Arm 3 Experimental Treatment 1 Intervention

Active IMP

Group IV: Arm 2 Experimental Treatment 1 Intervention

Active IMP

Group V: Arm 1 Experimental Treatment 1 Intervention

Active IMP

Group VI: Arm 6 Placebo Group 1 Intervention

Matching placebo for each of the 5 active arms

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Research Site Farmington Hills, MI

Research Site Tampa, FL

Research Site Guelph, Canada

Research Site Austin, TX

More Trial Locations

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4491

Patients Recruited

290,540,000+

Findings from Research

In a study of 648 obese patients undergoing bariatric surgery, it was found that mutations in the Melanocortin-4 Receptor (MC4R) did not impact weight loss outcomes over one year post-surgery.

Regardless of the type of MC4R mutation or polymorphism, patients experienced similar weight loss compared to matched controls, indicating that these genetic factors do not influence the effectiveness of bariatric surgery for weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Melanocortin-4 receptor mutations and polymorphisms do not affect weight loss after bariatric surgery. Valette, M., Poitou, C., Le Beyec, J., et al.[2021]

The melanocortin-4 receptor (MC4R) is crucial for regulating body weight, with mutations in this gene linked to both rare monogenic obesity and common obesity, highlighting its importance in energy balance.

Setmelanotide, a novel MC4R agonist, has been developed and shows promise for treating obesity without causing harmful cardiovascular side effects, potentially benefiting both rare and common obesity cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Melanocortin pathways: suppressed and stimulated melanocortin-4 receptor (MC4R). Hainer, V., Aldhoon Hainerová, I., Kunešová, M., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Melanocortin-4 receptor mutations and polymorphisms do not affect weight loss after bariatric surgery. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Functional Characterization of MC4R Variants in Chinese Morbid Obese Patients and Weight Loss after Bariatric Surgery. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Missense mutations and polymorphisms of the MC4R gene in Polish obese children and adolescents in relation to the relative body mass index. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Weight and Glycemic Control Outcomes of Bariatric Surgery and Pharmacotherapy in Patients With Melanocortin-4 Receptor Deficiency. [2022]

5. Czech Republic pubmed.ncbi.nlm.nih.gov

Melanocortin pathways: suppressed and stimulated melanocortin-4 receptor (MC4R). [2022]