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New pill aims to tackle obesity and diabetes by calming inflammation

NCT ID NCT07055516

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 16, 2026 · Updated 5 times

Summary

This study tests an experimental drug called NT-0796 in 176 obese adults, some with type 2 diabetes. Participants take the drug or a placebo alongside a reduced-calorie diet and increased physical activity for 6 months. The goal is to see if the drug helps with weight loss and reduces inflammation, which is linked to diabetes complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NT-0796 (oral capsule)
What this could lead to
If it works, this could point toward a new weight-loss and anti-inflammatory treatment for obesity and type 2 diabetes.
What could go wrong
This is an early Phase 2a trial with only 176 participants, so results may not apply to everyone. The drug is still experimental and may not prove effective or safe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

176 people

The number who actually took part.

Started

May 2025

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female aged 18 to 75 years (inclusive) at screening who have signed informed consent and are willing and able to comply with the study protocol. * Have a BMI of ≥30.0 kilogram/square meter (kg/m2) and \<40.0 kg/m2. (BMI values should be calculated to one decimal point precision and then assessed in terms of the required range.) * History of at least one self-reported unsuccessful dietary effort to lose body weight. * Group 1: Have a diagnosis of T2DM, with HbA1c \< 10% (86 mmol/mol) (measured at central lab during screening) and are on stable treatment for T2DM for at least 90 days prior to screening. * Group 2: No diagnosis or signs/symptoms of T2DM and HbA1c \< 6.5% (48 mmol/mol), measured at the central lab during screening. Exclusion Criteria: * T1DM, or a history of ketoacidosis, or hyperosmolar state/coma requiring hospitalization at any time prior to screening. * Have had 1 or more episode(s) of severe hypoglycemia in the 6 months prior to screening (Level 3 ADA 2025) 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. * History of stroke with residual neurological deficit within 2 years or transient ischemic attack within 6 months prior to Day 1. * History of acute coronary syndrome (ACS) including unstable angina, acute myocardial infarction (both ST segment elevation and non-ST segment elevation) within 6 months prior to Day 1. * Diagnosis of congestive heart failure (CHF) or clinical evidence suggesting CHF including history of orthopnea, exertional dyspnea, pedal edema, pulmonary rales, hepatosplenomegaly or cardiomegaly at the discretion of the Principal Investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Investigative Site

    Hialeah, Florida, 33016, United States

  • Investigative Site

    Jacksonville, Florida, 32216, United States

  • Investigative Site

    Miami, Florida, 33147, United States

  • Investigative Site

    Port Orange, Florida, 32127, United States

  • Investigative Site

    Columbus, Ohio, 43213, United States

  • Investigative Site

    Dallas, Texas, 75230, United States

  • Investigative Site

    Manassas, Virginia, 20110, United States

  • Investigative Sites

    Marrero, Louisiana, 70006, United States

  • Investigative site

    Mesa, Arizona, 85225, United States

  • Investigative site

    Los Angeles, California, 90057, United States

  • Investigative site

    Cooper City, Florida, 33024, United States

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