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Not yet recruitingNCT07896109Updated Oct 26, 2026

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

A Phase 1 interventional study of NNC9836-0001 and Placebo (NaCl) in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Not yet recruiting at 1 site in Germany. Open to participants aged 25 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.

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

Updated Oct 26, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
121
Allocation
Randomized
Ages
25 Years to 69 Years
Sex
All
01

Study 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. Which treatment participants get is decided by chance. NNC9836-0001 is a new medicine aimed to treat type 2 diabetes.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus, Type 2

9,590 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's planned enrollment of 121 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,401 studies on the registry; 102 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 98 (48%) have results posted.

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

04

Who can participate

Ages eligible
25 Years to 69 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

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.
  • 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.

Exclusion criteria

Exclusion Criteria:

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.
  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
121 participants (estimated)

Study arms

  • Experimental
    NNC9836-0001

    Participants will receive NNC9836-0001 subcutaneously.

    Drug: NNC9836-0001

  • Placebo comparator
    Placebo

    Participants will receive placebo subcutaneously.

    Drug: Placebo (NaCl)

Interventions

  • DrugNNC9836-0001

    NNC9836-0001 will be administered subcutaneously.

  • DrugPlacebo (NaCl)

    Placebo (NaCl) will be administered subcutaneously.

06

What researchers measure

Primary outcomes

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

    Measured as events.

    Time frame: From dosing (day 1) until week 26

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

    Measured as events.

    Time frame: From dosing (day 1) to week 34

Secondary outcomes

  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).

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: From predose day 29 to day 57

07

Study locations

1 site
  • Profil Institut für Stoffwechselforschung GmbH
    Neuss, 41460, Germany
08

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.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 reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Jul 2028, 21 months later.

Of 393 industry-sponsored phase 1 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 12. This study's planned 21 months is above that.

Counting every sponsor, half of 458 studies reached it within 7 months; a quarter within 2 and three quarters within 14.

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

Registered
Oct 19, 2026
First posted
Oct 26, 2026
StartEst.
Oct 21, 2026
Primary completionEst.
Jul 26, 2028
CompletionEst.
Jul 26, 2028
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.
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

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
NCT07896109
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Oct 26, 2026
Start date
Oct 21, 2026 (estimated)
Primary completion
Jul 26, 2028 (estimated)
Completion
Jul 26, 2028 (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
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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