Suzetrigine for Diabetic Neuropathy

Recruiting at 12 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Vertex Pharmaceuticals Incorporated

Disqualifiers: Sensory abnormalities, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

734 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Suzetrigine to evaluate its effectiveness and safety for people with pain from diabetic peripheral neuropathy (DPN). DPN causes pain and numbness in the feet and legs due to diabetes. Participants will receive either Suzetrigine or a placebo (a pill with no active ingredients) to compare results. Individuals with diabetes and painful feet or legs for at least a year might be a good fit. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

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 Suzetrigine is likely to be safe for humans?

Research has shown that Suzetrigine is generally safe for people. In one study, most participants tolerated Suzetrigine well, experiencing only mild or moderate side effects. Importantly, the study linked no serious side effects to the drug. Another study found that fewer participants experienced side effects with Suzetrigine (22.9%) compared to those taking a placebo (32.4%). Overall, these findings suggest Suzetrigine is safe for treating pain, including conditions like diabetic nerve pain. ^{1 2 3 4 5}

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

Unlike the standard treatments for diabetic neuropathy, which often include medications like gabapentin and duloxetine that primarily aim to relieve pain, Suzetrigine offers a unique approach. Suzetrigine is designed to target the underlying nerve damage directly, potentially leading to more effective and long-lasting relief. Researchers are excited about Suzetrigine because it could not only alleviate pain but also improve nerve function, which sets it apart from existing options that mainly focus on symptom management. This novel mechanism of action holds promise for providing a more comprehensive treatment for those suffering from diabetic neuropathy.

What evidence suggests that Suzetrigine might be an effective treatment for diabetic neuropathy?

Research has shown that Suzetrigine, which participants in this trial may receive, helps reduce pain for people with diabetic nerve pain. In a previous study, Suzetrigine significantly lowered pain levels on a simple pain scale. Patients experienced lasting pain relief starting as early as the first week, with continued improvement up to the fifth week. Suzetrigine works by specifically blocking pain signals, managing pain without using opioids. Overall, these findings suggest Suzetrigine could be a promising option for managing diabetic nerve pain. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults who weigh at least 45 kg and have a BMI of 18-40. They must have type 1 or type 2 diabetes with controlled HbA1c (≤9%) and suffer from painful diabetic neuropathy in both legs for at least a year. Their pain levels should be moderate but not too variable recently.

Inclusion Criteria

Key

My average pain score is between 4 and 9 over the last week.

My weight is at least 45 kg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Suzetrigine or placebo for the duration of the study

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Suzetrigine

Trial Overview

The study tests Suzetrigine's effectiveness, safety, and how well people can tolerate it compared to a placebo in relieving pain caused by diabetic peripheral neuropathy.

How Is the Trial Designed?

Group I: Suzetrigine (SUZ) Experimental Treatment 1 Intervention

Participants will be randomized to receive SUZ.

Group II: Placebo Placebo Group 1 Intervention

Participants will be randomized to receive placebo matched to SUZ.

Who Is Running the Clinical Trial?

Vertex Pharmaceuticals Incorporated

Lead Sponsor

Trials

267

Recruited

36,100+

Dr. David Altshuler

Vertex Pharmaceuticals Incorporated

Chief Medical Officer since 2020

MD, PhD

Dr. Reshma Kewalramani

Vertex Pharmaceuticals Incorporated

Chief Executive Officer since 2020

MD, trained in internal medicine and nephrology

Citations

1.

news.vrtx.com

news.vrtx.com/news-releases/news-release-details/vertex-announces-results-phase-2-study-suzetrigine-treatment

Vertex Announces Results From Phase 2 Study of Suzetrigine ...

The study met its primary endpoint with statistically significant and clinically meaningful reduction in pain on the numeric pain rating scale (NPRS).

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06628908

Study Details | NCT06628908 | Evaluation of Efficacy and ...

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) in participants with pain associated with diabetic ...

3.

neurology.org

neurology.org/doi/10.1212/WNL.0000000000210760

Suzetrigine, a Selective Pain Signal Inhibitor of NaV1.8 ...

All suzetrigine dose groups had sustained mean reductions in pain from baseline starting at Wk1; pain continued to decrease until Wk5, which was maintained ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12624754/

Suzetrigine, a Non‐Opioid Small‐Molecule Analgesic

Suzetrigine has been evaluated in a series of early and late‐phase clinical trials to demonstrate its efficacy and safety in both post‐surgical ...

5.

clinicaltrials.vrtx.com

clinicaltrials.vrtx.com/studies/nct06628908?condition%5Beq%5D=Diabetic+Peripheral+Neuropathic+Pain

Evaluation of Efficacy and Safety of Suzetrigine for Pain ...

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) in participants with pain associated with diabetic ...

6.

investors.vrtx.com

investors.vrtx.com/news-releases/news-release-details/vertex-announces-results-phase-2-study-suzetrigine-treatment

Vertex Announces Results From Phase 2 Study of ...

Suzetrigine was generally well tolerated in the study. The incidence of adverse events (AEs) was 22.9% in the suzetrigine arm and 32.4% in the ...

7.

trialx.com

trialx.com/clinical-trials/listings/296497/evaluation-of-efficacy-and-safety-of-suzetrigine-for-pain-associated-with-diabetic-peripheral-neuropathy/

Evaluation of Efficacy and Safety of Suzetrigine for Pain ...

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) in participants with pain associated with diabetic ...