ClinicalTrials.gg
RecruitingNCT07829406Updated Oct 26, 2026

A Study to See How Safe a New Medicine (NNC0642-1895) is in Healthy People

A Phase 1 interventional study of NNC0642-1895 and Placebo in Healthy Volunteers, sponsored by Novo Nordisk A/S. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Oct 26, 2026Now RecruitingSite recruiting status changedGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
148
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This study is testing a new medicine, in healthy adults to assess its safety and understand how it behaves in the body. The purpose of this study is to evaluate the safety, tolerability, and how the body responds to a single dose of NNC0642-1895 in healthy adults. Participant will either get study medicine (NNC0642-1895) or placebo (a treatment that has no active medicine in it). Which treatment a participant receives is decided by chance. NNC0642-1895 is a new medicine that is being tested in humans for the first time and is not currently available for doctors to prescribe. The study will last for about 94 days (approximately 14 weeks).

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,404 studies on the registry; 101 are open to participants now.

Of its 205 completed or terminated interventional studies of FDA-regulated products, 100 (49%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  • (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, and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion criteria

Exclusion Criteria:

  • Known or suspected 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:

    • (ALT) greater than (>) (ULN) +10 percent (%)
    • Aspartate aminotransferase (AST) > ULN +20%
    • > ULN +20%
    • Creatinine > ULN +10%
    • > ULN
    • Absolute neutrophil count less than (\<) Lower limit of normal (LLN)
    • 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 ) 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.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
148 participants (estimated)

Study arms

  • Experimental
    NNC0642-1895

    Participants will be administered a single dose of NNC0537-1482 intravenously.

    Drug: NNC0642-1895

  • Placebo comparator
    Placebo

    Participants will receive placebo matched to NNC0642-1895 intravenously.

    Drug: Placebo

Interventions

  • DrugNNC0642-1895

    NNC0642-1895 will be administered intravenously.

  • DrugPlacebo

    Placebo will be administered intravenously.

06

What researchers measure

Primary outcomes

  1. Number of treatment emergent adverse events (TEAE)

    Measured as number of events.

    Time frame: From pre-dose (Day 1) to Day 66

Secondary outcomes

  1. AUC0-∞; the area under the NNC0642-1895 serum concentration-time curve from time 0 to infinity after a single dose

    Measured as nanomoles per liter hour (nmol/L\*h).

    Time frame: From pre-dose (Day 1) to Day 66

  2. Cmax; the observed maximum serum concentration of NNC0642-1895 after a single dose

    Measured as nanomoles per liter (nmol/L).

    Time frame: From pre-dose (Day 1) to Day 66

07

Study locations

1 of 1 sites recruiting
  • ICON-Salt Lake City
    Salt Lake City, Utah 84124, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisktrials.com

Data sharing details ↗ · novonordisk-trials.com

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2026 (actual). Primary completion is estimated for Sep 2027, 11 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2026
First posted
Sep 21, 2026
StartActual
Sep 17, 2026
Primary completionEst.
Sep 12, 2027
CompletionEst.
Sep 12, 2027
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 26, 2026
Sites
ICON-Salt Lake City is now Recruiting
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    Not yet recruiting→Recruiting
    ICON-Salt Lake City is now Recruiting
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07829406
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Sep 21, 2026
Start date
Sep 17, 2026
Primary completion
Sep 12, 2027 (estimated)
Completion
Sep 12, 2027 (estimated)
Last update
Oct 26, 2026

Study contacts

Novo Nordisk
Contact
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Clinical Transparency (dept. 2834)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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