NT-0796 for Obesity

Not currently recruiting at 11 trial locations

Overseen By Senior Director of Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NodThera Limited

Disqualifiers: T1DM, Stroke, Heart failure, 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: 2

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a new medication, NT-0796, in aiding weight loss for individuals with obesity. Participants will take either NT-0796 or a placebo (a pill resembling the real medication but without active ingredients) while adhering to a diet and exercise plan for six months. The study is open to individuals who have struggled to lose weight through diet alone, with or without type 2 diabetes. Eligible participants have a body mass index (BMI) of 30 to 40 and have not been diagnosed with certain serious medical conditions, such as a recent stroke or heart problems. As a Phase 2 trial, this research measures NT-0796's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant advancements in obesity 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. However, if you have Type 2 Diabetes, you must be on stable treatment for at least 90 days before joining the trial.

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. In earlier studies, NT-0796 proved to be safe and well tolerated, with most side effects being mild and temporary. These findings suggest that NT-0796 could be a safe choice for those considering joining a clinical trial. However, since this trial remains in an early stage, safety continues to be studied. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for obesity, which often involve lifestyle changes, medications like orlistat, or even surgical options, NT-0796 offers a novel approach. Researchers are excited because NT-0796 involves a unique oral capsule formulation that could simplify dosing, either as a twice-daily regimen or a once-daily dose combined with a placebo. This flexibility in administration could make it more convenient for patients, potentially improving adherence and outcomes. Additionally, the specific active ingredient, NT-0796, might work through a new mechanism of action, offering hope for patients who haven't found success with current therapies.

What evidence suggests that NT-0796 might be an effective treatment for obesity?

Research has shown that NT-0796 might help people with obesity lose weight. In this trial, participants will receive NT-0796 either twice daily or once daily, with a placebo as the second daily dose. Studies have found that using NT-0796 along with semaglutide led to more weight loss than using semaglutide alone. NT-0796 enhances and maintains the effects of semaglutide. Additionally, NT-0796 is believed to lower inflammation in the body, which could aid in managing obesity. These findings suggest that NT-0796 could be a promising treatment for obesity, especially when combined with other weight-loss medications. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with obesity (BMI ≥30 and <40) who've tried to lose weight unsuccessfully. Group 1 includes those with Type 2 Diabetes Mellitus (T2DM), stable on treatment, and HbA1c levels between ≥6.5% and <10%. Group 2 has no T2DM diagnosis or symptoms, with an HbA1c level below 6.5%. Participants must be willing to follow the diet and exercise plan.

Inclusion Criteria

Have a BMI of ≥30.0 kg/m2 and <40.0 kg/m2

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

I don't have type 2 diabetes and my HbA1c level is below 6.5%.

Exclusion Criteria

Have had 1 or more episode(s) of severe hypoglycemia in the 6 months prior to screening defined as a severe event characterized by altered mental and/or physical status requiring assistance for treatment of hypoglycemia irrespective of glucose level, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms. Any participant that the investigator feels will not be able to communicate an understanding of hypoglycemic symptoms and the appropriate treatment of hypoglycemia should also be excluded

I have type 1 diabetes or have been hospitalized for severe diabetic complications.

I had a stroke with lasting effects within the last 2 years or a minor stroke in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive NT-0796 or placebo as an adjunct to a reduced calorie diet and increased physical activity

24 weeks

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• NT-0796

Trial Overview The study tests NT-0796's effectiveness in aiding weight loss alongside a reduced-calorie diet and increased physical activity over six months. It's a Phase 2a trial where participants are randomly assigned to receive either NT-0796 or a placebo without knowing which one they're getting.

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 24 weeks, containing NT-0796 twice daily

Group II: Once daily orally administered NT-0796 capsules and placebo second daily dose Experimental Treatment 2 Interventions

Participants will receive study medication twice daily orally for up to 24 weeks, containing NT-0796 once daily, with once daily placebo

Group III: Placebo orally administered capsule Placebo Group 1 Intervention

Participants will receive placebo twice daily orally for up to 24 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 ... RESOLVE-1 is a randomized, double-blind, placebo-controlled Phase 2 trial that will evaluate the efficacy and safety of NT-0796 in patients with obesity.

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

The NLRP3 inhibitor NT‐0796 enhances and sustains GLP ... The brain penetrant NLRP3 inhibitor NT‐0796 enhances and sustains the efficacy of the GLP‐1RA semaglutide, leading to a complete reversal of obesity.

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

Evaluate the Efficacy and Safety of NT-0796 in Participants ... A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NT-0796 as an Adjunct to a Reduced Calorie Diet and ...

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

The NLRP3 inhibitor NT‐0796 enhances and sustains GLP ... A centrally penetrant NLPR3 inhibitor, NT-0796, drives enhanced weight loss when combined with low-dose semaglutide, compared to monotherapy.

5. neurologylive.com neurologylive.com/view/anti-inflammatory-effects-nt-0796-warrant-future-studies-parkinsons-neurodegeneration

Anti-Inflammatory Effects of NT-0796 Warrant Future ... A new study reveals NT-0796's potential to reduce neuroinflammation in Parkinson's disease, paving the way for future treatments.

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

Anti‐Neuroinflammatory and Anti‐Inflammatory Effects of the ... Results. NT-0796 was safe and well tolerated with minimal adverse events. A reduced peak-to-trough ratio along with moderately higher exposure ...