NT-0796 + Semaglutide for Obesity

(RESOLVE-2 Trial)

Recruiting at 9 trial locations

Overseen By Senior Director of Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NodThera Limited

Must be taking: Semaglutide

Must not be taking: Incretins, Anti-diabetic medications

Disqualifiers: Diabetes, Stroke, Coronary syndrome, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

Duration: 20 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether NT-0796, an experimental treatment, can safely and effectively aid individuals with obesity when combined with semaglutide, a common weight management medication. Participants will receive either NT-0796 or a placebo (a pill without active medicine) to assess its impact on weight over six months. The trial seeks adults with a BMI between 30 and 45 who have unsuccessfully attempted weight loss through diet and plan to start semaglutide treatment. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in obesity treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used incretins in the past 12 months or are on any anti-diabetic medications.

Is there any evidence suggesting that NT-0796 is likely to be safe for humans?

Research has shown that NT-0796 is generally safe for people. One study found NT-0796 to be safe, with only a few minor side effects reported, indicating that most participants did not experience serious problems. Researchers are also testing NT-0796 for other health issues, such as brain diseases and long-term inflammation, which suggests confidence in its safety. Although NT-0796 remains under study, its testing in humans for other conditions offers some reassurance about its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard obesity treatments, which often involve lifestyle changes and medications like orlistat or GLP-1 receptor agonists such as liraglutide, NT-0796 offers a fresh approach. NT-0796 is unique because it is administered as a twice-daily oral capsule and may provide a different mechanism of action compared to current options. Researchers are excited about NT-0796 because it has the potential to enhance weight loss effects when used alongside semaglutide, another well-known obesity medication. This combination could offer a more effective solution for weight management, particularly for those who haven't achieved desired results with existing treatments.

What evidence suggests that NT-0796 as an adjunct to semaglutide could be effective for obesity?

Research has shown that NT-0796, when combined with semaglutide, results in greater weight loss than either treatment alone. In this trial, participants will receive either NT-0796 or a placebo. Studies have found that the combination of NT-0796 and semaglutide led to significant weight loss in early tests, suggesting its potential effectiveness for treating obesity. Specifically, one study showed participants lost 15% or more of their body weight over 24 weeks. NT-0796 works by blocking NLRP3, a component of the immune system linked to inflammation and weight gain. This combination treatment could enhance the effectiveness of semaglutide, offering promise for those struggling with obesity. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with obesity who are seeking additional treatment options. Participants must be eligible to take semaglutide, a medication already used for weight management. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

History of at least one self-reported unsuccessful dietary effort to lose body weight

My BMI is between 30 and 45.

I am between 18 and 75 years old and agree to follow the study rules.

Exclusion Criteria

Known hypersensitivity to semaglutide or any of its excipients, or previous inability to tolerate semaglutide

I have diabetes or my HbA1c level is 6.5% or higher.

I had a stroke or mini-stroke recently and still have effects from it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive NT-0796 or placebo twice daily, along with semaglutide, for up to 20 weeks

20 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NT-0796

Trial Overview The study tests the safety and effectiveness of NT-0796 when taken alongside semaglutide, compared to a placebo group also on semaglutide. It's a double-blind study, meaning neither participants nor researchers know who gets the real drug or placebo.

How Is the Trial Designed?

Group I: Twice daily orally administered NT-0796 capsule Experimental Treatment 1 Intervention

Participants will receive study medication twice daily orally for up to 20 weeks, containing NT-0796 twice daily

Group II: Placebo orally administered capsule Placebo Group 1 Intervention

Participants will receive placebo twice daily orally for up to 20 weeks

Who Is Running the Clinical Trial?

NodThera Limited

Lead Sponsor

Trials

1

Recruited

70+

Citations

1. nodthera.com nodthera.com/news/nodthera-charts-obesity-future-with-first-patients-dosed/

NodThera Charts Obesity Future with First Patients Dosed ... Most recently, data published in the journal Obesity showed the enhanced weight loss effect of NT-0796 when combined with semaglutide in a ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12210099/

The NLRP3 inhibitor NT‐0796 enhances and sustains GLP ... Combined dosing of NT‐0796 with semaglutide drove greater weight loss than either monotherapy alone, and this effect was enhanced in mice ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07055516

Evaluate the Efficacy and Safety of NT-0796 in Participants ... Incidence of body weight loss ≥15% in participants with obesity with and without T2DM, Baseline to Week 24. Change in metabolic biomarker in participants ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/oby.24305

The NLRP3 inhibitor NT‐0796 enhances and sustains GLP ... Combined dosing of NT-0796 with semaglutide drove greater weight loss than either monotherapy alone, and this effect was enhanced in mice ...

5. sofinnovapartners.com sofinnovapartners.com/news/nodthera-s-oral-nlrp3-inhibitor-nt-0796-enhances-and-sustains-weight-loss-in-combination-with-glp-1

NodThera's oral NLRP3 inhibitor NT-0796 enhances and ... Data published in Obesity journal show enhanced weight loss effect of NT-0796 when combined with semaglutide in preclinical obesity model.

6. invivogen.com invivogen.com/nt-0796-nlrp3-inhibitor

NT-0796 | CAS: 2272917-13-0 | NLRP3 inhibitor It is currently being tested in clinical trials for its potential in treating neurodegenerative diseases (e.g. Parkinson's) and chronic inflammation in obesity ...

7. movementdisorders.onlinelibrary.wiley.com movementdisorders.onlinelibrary.wiley.com/doi/full/10.1002/mds.30307

Anti‐Neuroinflammatory and Anti‐Inflammatory Effects of the ... NT-0796 was safe and well tolerated with minimal adverse events. ... The exposure data demonstrate NT-0796's capacity to fully penetrate ...