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Novo nordisk tests Brand-New molecule in humans for the first time

NCT ID NCT07829406

NEW 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are running a first-in-human trial of NNC0642-1895, an experimental medicine given as a single intravenous dose. The study enrolls about 148 healthy adults aged 18 to 55 with a body mass index between 18.5 and 29.9. Participants receive either the drug or a placebo, assigned by chance, and researchers track side effects and measure how the drug moves through the body over roughly 14 weeks.

What this could mean

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

Active substance
NNC0642-1895, an experimental medicine given as a single intravenous dose
What this could lead to
If the drug proves safe and behaves predictably in the body, it could move into later trials that test whether it helps people with a specific disease.
What could go wrong
This is a first-in-human study, so researchers know little about how the drug affects people. It may cause unexpected side effects, and most drugs at this stage do not advance to become approved treatments.

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

About 148 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

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

Anyone

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 or female (sex assigned at birth, inclusive of all gender identities). * Age 18-55 years (both inclusive) at the time of signing the informed consent. * Body Mass Index (BMI) between 18.5 to 29.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening * Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. Exclusion Criteria: * Known or suspected hypersensitivity to study intervention(s) or related products. * Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values: * Alanine aminotransferase (ALT) greater than (\>) Upper limit of normal (ULN) +10 percent (%) * Aspartate aminotransferase (AST) \> ULN +20% * Bilirubin \> ULN +20% * Creatinine \> ULN +10% * Absolute neutrophil count \> ULN * Absolute neutrophil count less than (\<) Lower limit of normal (LLN) * Platelet count \> ULN * Platelet count \< LLN * Supine blood pressure at screening outside the range of 90-139 millimeters of mercury (mmHg) for systolic or 50-89 mmHg for diastolic * Heart rate outside the range of 50-90 beats/min at screening * Use of prescription (except contraceptives) or non-prescription medicinal products within 14 days before screening. Occasional use of over-the-counter acetaminophen or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) at their labelled doses is permitted.

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As listed by the trial registrant

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

Healthy volunteers

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • ICON-Salt Lake City

    Salt Lake City, Utah, 84124, United States

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