ALN-4324 for Obesity

Recruiting at 18 trial locations

Overseen By Alnylam Clinical Trial Information Line

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Alnylam Pharmaceuticals

Disqualifiers: HIV, Hepatitis C, Hepatitis B, others

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ALN-4324 to determine its safety and effectiveness for individuals who are overweight or obese, particularly those with type 2 diabetes (T2DM). In the first part, healthy volunteers receive a single dose to assess safety. The second part involves multiple doses for people with T2DM who have high blood sugar levels. This trial suits adults with T2DM who are on a stable dose of metformin and have a BMI (body mass index) between 25 and 45. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that ALN-4324 is likely to be safe for humans?

Research shows that ALN-4324 is being tested for safety in single and multiple doses. Results from earlier studies indicate that ALN-4324 is generally well-tolerated by healthy volunteers, with most experiencing no serious side effects. No major safety issues have been reported.

This study is in the early stages (Phase 1/Phase 2) and primarily aims to assess the treatment's safety in humans. Although detailed results from earlier trials are limited, the continuation of the study suggests that any unwanted effects were manageable and not severe. However, since the treatment is still under investigation, some risks may not yet be fully known. Participants should consult the study team for more information and to address any questions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Unlike the standard treatments for obesity, which often include lifestyle changes, medications like orlistat, or even surgical options like gastric bypass, ALN-4324 offers a fresh approach. Researchers are excited about ALN-4324 because it potentially targets obesity at the genetic level. This treatment uses RNA interference (RNAi) technology to silence specific genes associated with fat accumulation, which could offer a more direct and potentially more effective way to combat obesity. Additionally, while many obesity treatments can take weeks or months to show results, ALN-4324 might deliver noticeable effects more quickly, particularly with its innovative dosing strategy involving both single and multiple doses.

What evidence suggests that ALN-4324 might be an effective treatment for obesity?

Research has shown that new anti-obesity medications, such as ALN-4324, have led to significant weight loss in clinical trials. These treatments affect the body's natural weight control systems. In this trial, participants will receive either a single or multiple doses of ALN-4324, or a placebo. Although ALN-4324 is still under study, early results from similar drugs suggest it could aid weight loss in individuals who are overweight or obese. Ongoing studies are also examining its potential to manage conditions like type 2 diabetes, making it a promising option for treating obesity. ^{1 3 6 7 8}

Who Is on the Research Team?

Medical Director

Principal Investigator

Alnylam Pharmaceuticals

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Part B: ALN-4324 Experimental Treatment 1 Intervention

Participants will be administered multiple doses of ALN-4324

Group II: Part A: ALN-4324 Experimental Treatment 1 Intervention

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

Group III: Part A: Placebo Placebo Group 1 Intervention

Participants will be administered a single dose of placebo.

Group IV: Part B: Placebo Placebo Group 1 Intervention

Participants will be administered multiple doses 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

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.alnylam.com clinicaltrials.alnylam.com/trials/6845202

ALN-4324-001 - Alnylam Clinical Trials The purpose of this study is to evaluate the safety and tolerability of single ascending doses of ALN-4324 in healthy volunteers.

2. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/579275

A Study to Evaluate ALN-4324 in Overweight to Obese ... The purpose of this study is to evaluate the safety and tolerability of single ascending doses of ALN-4324 in healthy volunteers.

3. withpower.com withpower.com/trial/phase-1-overweight-2-2025-8af96

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, ...

4. fdaaa.trialstracker.net fdaaa.trialstracker.net/trial/NCT06845202/

NCT06845202: An ongoing trial by Alnylam Pharmaceuticals This trial is ongoing. It must report results 2 years, 9 months from now. Full data. Full entry on ClinicalTrials.gov ...

5. trialx.com trialx.com/clinical-trials/listings/298045/a-phase-1-study-to-evaluate-aln-4324-in-overweight-to-obese-healthy-volunteers/

A Phase 1 Study to Evaluate ALN-4324 in Overweight ... Overview. The purpose of this study is to evaluate the safety and tolerability of single ascending doses of ALN-4324 in healthy volunteers ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/579275

A Phase 1 Study to Evaluate ALN-4324 in Overweight ... The purpose of this study is to evaluate the safety and tolerability of single ascending doses of ALN-4324 in healthy volunteers and to ...

7. ctv.veeva.com ctv.veeva.com/study/a-phase-1-study-to-evaluate-aln-4324-in-overweight-to-obese-healthy-volunteers

A Study to Evaluate ALN-4324 in Overweight to Obese ... The purpose of this study is to: evaluate the safety and tolerability of single ascending doses of ALN-4324 in healthy volunteers and to ...

8. synapse.patsnap.com synapse.patsnap.com/drug/c5b938dc6cf444e7acb289efe0b4d6d1

ALN-4324 - Drug Targets, Indications, Patents ... ALN-4324 in Overweight to Obese Patients With Type 2 Diabetes Mellitus (T2DM). 100 Clinical Results associated with ALN-4324. Login to view more data. 100 ...