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Diabetes Mellitus, Type 2Phase 1NCT07896109

A Research Study to Check the Safety of NNC9836-0001 When Given to Healthy Participants and Participants With Type 2 Diabetes

A Phase 1 study testing NNC9836-0001 in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this clinical study is to determine if the study medicine NNC9836-0001 is safe and tolerable in healthy participants with overweight or obesity or who have type 2 diabetes (T2D). Participants will either get the study medicine NNC9836-0001 or placebo. Read more about this study

Who is it for?
Ages 25 to 69 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
NNC9836-0001
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
121 participants
Where
1 siteGermany
Study dates
21 Oct 2026to 26 Jul 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 69 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All participants:
  • Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
  • Male or female (sex assigned at birth, inclusive of all gender identities).
  • Metabolically healthy participants with overweight or mild obesity:
  • Age 25 to 59 years (both inclusive) at the time of signing the informed consent.
  • Body Mass Index (BMI) 25 to 34.9 kilogram per square meter (kg/m^2) (both inclusive) at screening.
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  • Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator.
  • Participants with type 2 diabetes:
  • Age at the time of signing the informed consent: Age 25 to 69 years (both inclusive)
  • BMI at screening: BMI 27 to 39.9 kg/m^2 (both inclusive)
  • Diagnosed with T2D greater than equal to (≥) 180 days before screening.
  • Concomitant medications before screening: Stable (as judged by the investigator) with daily dose(s) on monotherapy (metformin, sodium-glucose cotransporter 2 inhibitors (SGLT2i), or dipeptidyl peptidase-4 inhibitor (DPP4i) or dual therapy (metformin + SGLT2i or metformin + DPP4i)) ≥90 days before screening. or; Stable weight and stable doses of glucagon-like peptide-1 receptor agonists (GLP-1 RA) with no further titration (as judged by the investigator). GLP-1 RA ≥180 days before screening combined with daily dose(s) of either metformin or SGLT2i or dual therapy (metformin + SGLT2i)) ≥90 days before screening.
  • Background pharmacotherapy for all MAD cohort T2D participants should be on stable therapy for ≥90 days before screening with no initiation, discontinuation, or dose changes.
  • Considered to be generally healthy as judged by the investigator except for T2D-associated mild conditions under stable treatment.

Who cannot join

  • All participants:
  • Known or suspected hypersensitivity to study intervention(s) or related products.
  • Previous dose administration in this study.
  • Participation (i.e., signed informed consent and dosed with Investigational medicinal product (IMP)) in any other interventional clinical study within 30 days or 5 times the half-life of the drug, whichever is longest, before screening.
  • Any disorder, which in the investigator's opinion might jeopardise participants safety or compliance with the protocol.
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
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  • Minimal to mild hepatic impairment, defined as alanine aminotransferase (ALT) values greater than (>)1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) values >1.5 × ULN, or total bilirubin >ULN + 20 percent (%) (except in case of Gilbert's disease, as reported by participant or in medical records) at screening.
  • Metabolically healthy participants with overweight or mild obesity:
  • Supine blood pressure outside the range of 90-139 millimetres of mercury (mmHg) for systolic or 50-89 mmHg for diastolic at screening. To consider re-assessment of vital signs in case white-coat hypertension is known or suspected.
  • Heart rate outside the range of 45-89 beats per minute (bpm) at screening.
  • Unwilling or unable to refrain from use of nonprescription products within 14 days prior to start of run-in, including herbal products and nonroutine vitamins (as judged by the investigator), except the occasional use of over the counter (OTC) acetaminophen or non-steroidal anti-inflammatory drugs (NSAIDs) at their labelled doses for mild pain.
  • Recent (<90 days) or planned major change in diet, use of weight-lowering medication, regularly extended fasting periods, or dietary habits that, per investigator's judgment, may interfere with the conduct of the study.
  • Participants with type 2 diabetes:
  • Any disorder which in the investigator's opinion might jeopardise participant safety or compliance with the protocol. This does not apply for T2D-associated mild conditions under stable treatment.
  • Supine blood pressure outside the range of 90-159 mmHg for systolic or 50-99 mmHg for diastolic at screening. This exclusion criterion also pertains to participants being on antihypertensive treatment. To consider re-assessment of vital signs in case white-coat hypertension is known or suspected.
  • Heart rate outside the range of 50-99 bpm at screening.
  • Unwilling or unable to check self-monitored plasma glucose (SMPG) and unwilling to treat hypoglycaemia per instructions.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Novo Nordisk contact

(+1) 866-867-7178

clinicaltrials@novonordisk.com

Germany1 site

  • Profil Institut für Stoffwechselforschung GmbH

    Neuss, 41460

Other trials in Germany

About this study

Official title: A Phase 1 Randomised, Double-blinded, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of NNC9836-0001 Administered to Healthy Participants and Participants With Type 2 Diabetes

The purpose of this clinical study is to determine if the study medicine NNC9836-0001 is safe and tolerable in healthy participants with overweight or obesity or who have type 2 diabetes (T2D). Participants will either get the study medicine NNC9836-0001 or placebo. Which treatment participants get is decided by chance. NNC9836-0001 is a new medicine aimed to treat type 2 diabetes.

Being tested
NNC9836-0001, Placebo (NaCl)
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NNC9836-0001Drug

    NNC9836-0001 will be administered subcutaneously.

  • Placebo (NaCl)Drug

    Placebo (NaCl) will be administered subcutaneously.

Study groups in NCT07896109
Study groupRoleWhat they receive
NNC9836-0001ExperimentalParticipants will receive NNC9836-0001 subcutaneously.
Receives: Drug: NNC9836-0001
PlaceboPlacebo comparatorParticipants will receive placebo subcutaneously.
Receives: Drug: Placebo (NaCl)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Single ascending dose (SAD): Number of Treatment emergent adverse events (TEAEs)

    Measured as events.

    Measured: From dosing (day 1) until week 26

  2. Multiple ascending dose (MAD): Number of TEAEs

    Measured as events.

    Measured: From dosing (day 1) to week 34

Secondary outcomes (4)

  1. SAD: Area under the curve (AUC)0-last, standard deviation (SD): The area under the NNC9836-0001 plasma concentration-time curve from time zero to last measurable concentration after a single dose

    Measured as hours*nanograms per milliliter (h*ng/ml).

    Measured: From predose day 1 to day 57

  2. SAD:Cmax,SD: The maximum observed NNC9836-0001 plasma concentration after a single dose

    Measured as nanograms per milliliter (ng/ml).

    Measured: From predose day 1 to day 57

  3. MAD: AUC0-28d,MD: The area under the NNC9836-0001 plasma concentration-time curve after multiple doses

    Measured as hour*ng/mL.

    Measured: From predose day 29 to day 57

  4. MAD: Cmax,MD: The maximum observed NNC9836-0001 plasma concentration after multiple doses

    Measured as ng/mL.

    Measured: From predose day 29 to day 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2026
  2. Study start21 Oct 2026 (estimated)
  3. Primary completion26 Jul 2028 (estimated)
  4. Study completion26 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
121 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07896109
Sponsor's protocol ID
NN9836-8513
Other IDs
U1111-1328-6439
Status last verified
Oct 2026
First submitted
19 Oct 2026
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NNC9836-0001 in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Single ascending dose (SAD): Number of Treatment emergent adverse events (TEAEs) (time frame: From dosing (day 1) until week 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07896109.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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