156 Participants NeededMy employer runs this trial

ALN-2232 for Obesity

Recruiting at 1 trial location
AC
Overseen ByAlnylam Clinical Trial Information Line
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Alnylam Pharmaceuticals

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ALN-2232 to determine its safety and effectiveness for individuals with obesity. Researchers examine how single and multiple doses of ALN-2232 perform alone and in combination with tirzepatide. The study includes various groups, with some receiving the treatment and others a placebo (a harmless pill resembling the treatment). Suitable candidates for this trial have a body mass index (BMI) between 30 and 40 and are not currently taking medication for diabetes or weight management.

As a Phase 1 and Phase 2 trial, this study aims to understand how the treatment works in participants and measure its effectiveness in an initial group, offering participants a chance to contribute to groundbreaking obesity research.

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

Yes, you will need to stop taking any medications for chronic weight management or diabetes to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ALN-2232 is still undergoing testing to determine its safety for people. Since the testing process is in its early stages, limited information exists on how well participants tolerate it. In the initial trials, some participants received one or more doses of ALN-2232. These trials primarily aim to assess safety, but detailed information about side effects is not yet available.

As this study is in its early stages, safety remains the primary focus. Trials typically begin with low doses, gradually increasing them to observe how the body responds to the treatment. Prospective participants should be aware that any new treatment can have unknown effects. Safety checks in these trials are rigorous to protect participants.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about ALN-2232 for obesity because it offers a new approach to weight management. Unlike typical obesity treatments, which often focus on appetite suppression or calorie absorption, ALN-2232 may target a novel biological pathway, potentially leading to more effective weight loss. Furthermore, ALN-2232 is being tested in both single and multiple doses, which could provide flexibility in treatment plans. Additionally, its comparison with tirzepatide, another emerging treatment, highlights its potential to stand out among new therapies in terms of efficacy and patient outcomes.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that ALN-2232 works by turning off a specific gene in fat cells, differing from treatments that focus on reducing appetite. This gene-silencing method aims to change how the body handles and stores fat. Early results suggest it could help lower body weight in people with obesity. In this trial, participants will receive either ALN-2232 or a placebo to further evaluate its effectiveness. Although detailed results from human studies are not yet available, this method appears promising based on its effects in the body. Researchers are studying it further to determine its potential in effectively helping people with obesity.12345

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 (BMI between 30 and 40) who do not have diabetes (HbA1c less than 6.5%) and are generally healthy without other serious medical conditions. People already taking weight loss or diabetes medications cannot join.

Inclusion Criteria

Has a hemoglobin A1c (HbA1c) <6.5%
My BMI is between 30 and 40.

Exclusion Criteria

I do not have any serious health problems that could affect my safety in this study.
I am currently taking medication for weight management or diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single or multiple doses of ALN-2232, with or without tirzepatide

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ALN-2232

Trial Overview

The study is testing a new drug called ALN-2232, given alone in different doses or together with another medication called tirzepatide, compared to a placebo. The goal is to see how safe and effective these treatments are for people with obesity.

How Is the Trial Designed?

7

Treatment groups

Experimental Treatment

Placebo Group

Group I: Part C: TirzepatideExperimental Treatment1 Intervention
Group II: Part C: ALN-2232Experimental Treatment2 Interventions
Group III: Part B: ALN-2232Experimental Treatment1 Intervention
Group IV: Part A: ALN-2232Experimental Treatment1 Intervention
Group V: Part B: PlaceboPlacebo Group1 Intervention
Group VI: Part A: PlaceboPlacebo Group1 Intervention
Group VII: Part C: 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

A Study to Evaluate ALN-2232 in Participants With Obesity

The purpose of this study is to: evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of single ...

2.

clinicaltrials.alnylam.com

clinicaltrials.alnylam.com/trials/7463846

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