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New diabetes pill tested in humans for the first time

NCT ID NCT05521256

Knowledge-focused Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested a new experimental drug, NNC0113-6856, in 70 healthy men to see if it is safe and how the body processes it. Participants received either a single oral dose or an injection into the vein. The goal was to gather initial safety data and measure drug levels in the blood, not to treat any disease. This is a first step in possibly developing a new treatment for type 2 diabetes.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

70 people

The number who actually took part.

Started

Aug 2022

Finished

Mar 2023

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 55 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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. * Aged 18-55 years (both inclusive) at the time of signing informed consent. * Body mass index between 20.0 and 27.0 kilogram per meter square (kg/m\^2)(both inclusive). Exclusion Criteria: * Glycated haemoglobin (HbA1c) greater than or equal to (\>=) 6.5 percent (%) (48 millimoles per moles \[mmol/mol\]) at screening. * Use of tobacco and nicotine products, defined as any of the below: * Smoking more than 5 cigarettes or the equivalent per day. * Not willing to refrain from smoking and use of nicotine substitute products during the inpatient periods. * Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator. * History of major surgical procedures involving the stomach potentially affecting absorption of trial products (example: subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant * Presence or history of pancreatitis (acute or chronic). * Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. * Any of the below laboratory safety parameters at screening outside the below laboratory range, see "Log of laboratory ranges used for laboratory parameter exclusion criterion" for specific values: * Alanine Aminotransferase (ALT) greater than (\>) upper normal limit (UNL) * Aspartate aminotransferase (AST) \> UNL * Bilirubin \> UNL * Creatinine \> UNL * International normalized ratio (INR) \> UNL * Precence or history of hepatitis

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

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

Healthy volunteers Type 2 diabetes

Contacts and locations

Locations

  • Profil GmbH & Co. KG

    Mainz, 55116, Germany

  • Profil Institut für Stoffwechselforschung GmbH

    Neuss, North Rhine-Westphalia, 41460, Germany

  • Profil Institut für Stoffwechselforschung GmbH

    Neuss, 41460, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.