88 Participants NeededMy employer runs this trial

ALN-6222 for Obesity

AC
Overseen ByAlnylam Clinical Trial Information Line
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Alnylam Pharmaceuticals

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called ALN-6222 to determine its effectiveness for obesity. It tests the safety and effectiveness of a single dose compared to a placebo (a harmless, inactive substance). Participants will help researchers understand how the body processes this treatment and its impact on weight. The trial seeks adults with a body mass index (BMI) between 30 and 40 who do not have diabetes-related blood sugar levels (hemoglobin A1c below 6.5%). 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.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that ALN-6222 is likely to be safe for humans?

Research has shown that ALN-6222 is undergoing its first human trial to test safety. As a Phase 1 trial, the primary goal is to assess how safe and well-tolerated the treatment is in people. At this stage, researchers administer the treatment to a small group to monitor for any side effects.

Specific data on ALN-6222's safety is not yet available because it is new to human testing. However, treatments in this early phase often demonstrate initial safety if they progress to the next stages. Phase 1 trials focus on safety, so researchers closely monitor participants for any unwanted side effects.

As ALN-6222 is a new treatment, researchers are still collecting information about its safety. Participants in the study will help researchers understand how the body reacts to the treatment and whether it affects weight.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about ALN-6222 for obesity because it introduces a new mechanism that sets it apart from existing treatments like appetite suppressants and fat absorption inhibitors. Unlike these traditional methods, ALN-6222 may work by targeting specific pathways in the body that regulate fat storage, potentially offering a more direct and effective approach to weight management. This innovative mechanism could lead to more efficient weight loss with fewer side effects, making it a promising option for individuals struggling with obesity.

What evidence suggests that ALN-6222 might be an effective treatment for obesity?

Research has shown that ALN-6222 could be a promising treatment for obesity due to its mechanism of action. ALN-6222 employs RNA interference to inhibit specific genes from producing proteins, thereby targeting and reducing fat storage. Early studies of similar RNA-based treatments have demonstrated significant reductions in body fat, including visceral fat. Although human data specifically for ALN-6222 remains limited, these early indications suggest it might effectively reduce body fat and aid in obesity management. Participants in this trial will receive either a single dose of ALN-6222 or a placebo to assess its effectiveness.12356

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Alnylam Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults with obesity who are otherwise healthy. People with certain medical conditions or on specific medications may not be able to join.

Inclusion Criteria

Is an adult patient with a body mass index ≥30 kg/m² to <40 kg/m²
Has a hemoglobin A1c <6.5%

Exclusion Criteria

Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times the upper limit of normal (ULN)
I have HIV, hepatitis B, or hepatitis C infection.
Has an estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m² at screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ascending dose of ALN-6222 or placebo administered subcutaneously

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ALN-6222

Trial Overview

The study is testing a new drug called ALN-6222, given as an injection under the skin, compared to a placebo (inactive substance). Participants are randomly assigned and neither they nor the researchers know which treatment they're getting.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: ALN-6222Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

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

Citations

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