ALN-4324 for Obesity

Overseen By Alnylam Clinical Trial Information Line

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Alnylam Pharmaceuticals

Disqualifiers: HIV, Hepatitis C, Hepatitis B, others

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

84 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators for more details.

What data supports the effectiveness of the drug ALN-4324 for obesity?

The research highlights that new-generation anti-obesity medications, which may be similar to ALN-4324, have shown significant weight loss in clinical trials, with more than two-thirds of participants losing over 10% of their body weight. Additionally, treatments targeting the melanocortin pathway, like ALN-4324 might, have been effective in managing obesity, especially in individuals with specific genetic mutations. ^{1 2 3 4 5}

How does the drug ALN-4324 for obesity differ from other treatments?

ALN-4324 is unique because it may target genetic or hormonal causes of obesity by focusing on pathways like the melanocortin-4 receptor (MC4R), which are not effectively addressed by current treatments like lipase inhibitors or GLP-1 receptor agonists. This approach could be particularly beneficial for individuals with genetic mutations affecting these pathways. ^{5 6 7 8 9}

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and tolerability of single ascending doses of ALN-4324 in healthy volunteers and to characterize the single-dose PK of ALN-4324.

Research Team

Medical Director

Principal Investigator

Alnylam Pharmaceuticals

Eligibility Criteria

This trial is for healthy individuals who are overweight to obese, with a BMI between 27 and less than 40 kg/m2. It's not specified who can't join the trial beyond these criteria.

Inclusion Criteria

My BMI is between 27 and 40.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of ALN-4324 or placebo

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ALN-4324

Trial Overview The study is testing ALN-4324, which is a new potential treatment for obesity. Participants will receive either this drug or a placebo in varying doses to assess safety and how the body processes it.

Participant Groups

Group I: ALN-4324 Experimental Treatment 1 Intervention

Participants will be administered a single dose of ALN-4324.

Group II: Placebo Placebo Group 1 Intervention

Participants will be administered a single dose of placebo.

Who Is Running the Clinical Trial?

Alnylam Pharmaceuticals

Lead Sponsor

Trials

81

Recruited

16,100+

Dr. Yvonne Greenstreet

Alnylam Pharmaceuticals

Chief Executive Officer since 2021

MD from the University of Leeds, MBA from INSEAD

Dr. Pushkal Garg

Alnylam Pharmaceuticals

Chief Medical Officer since 2016

MD from Columbia University

Findings from Research

Obesity is a significant public health issue linked to various health risks, and while current pharmacological agents like lipase inhibitors and GLP-1 receptor agonists help reduce weight, they are not effective for genetic-related obesity disorders.

Emerging therapies targeting leptin and melanocortin-4 receptors (MC4Rs) show promise in treating genetic causes of obesity, with leptin analogs and MC4R agonists aiming to restore normal appetite and energy balance regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in Anti-obesity Pharmacotherapy: Current Treatments, Emerging Therapies, and Challenges. Brandfon, S., Eylon, A., Khanna, D., et al.[2023]

Liraglutide, a GLP-1 receptor agonist, is effective for weight loss in overweight or obese patients, showing greater weight reduction compared to placebo and orlistat, particularly at a dosage of 3 mg daily.

In addition to weight loss, liraglutide has been associated with significant health improvements, including reductions in waist circumference, blood pressure, and better lipid profiles, making it a beneficial option for patients with or without type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liraglutide, GLP-1 receptor agonist, for chronic weight loss. Moore, KG., Shealy, K., Clements, JN.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Contemporary medical, device, and surgical therapies for obesity in adults. [2023]

2. England pubmed.ncbi.nlm.nih.gov

An eight-year experience with a very-low-calorie formula diet for control of major obesity. [2014]

3. Brazil pubmed.ncbi.nlm.nih.gov

Prevalence of mutations in LEP, LEPR, and MC4R genes in individuals with severe obesity. [2021]

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

Treatment modalities of obesity: what fits whom? [2008]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of the Melanocortin 4-Receptor Ile269Asn Mutation on Weight Loss Response to Dietary, Phentermine and Bariatric Surgery Interventions. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Melanocortin-4 Receptor and Lipocalin 2 Gene Variants in Spanish Children with Abdominal Obesity: Effects on BMI-SDS After a Lifestyle Intervention. [2020]

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

Advances in Anti-obesity Pharmacotherapy: Current Treatments, Emerging Therapies, and Challenges. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Liraglutide, GLP-1 receptor agonist, for chronic weight loss. [2022]

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

Milestones in the journey towards addressing obesity; Past trials and triumphs, recent breakthroughs, and an exciting future in the era of emerging effective medical therapies and integration of effective medical therapies with metabolic surgery. [2023]