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

November 5, 2026 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
121

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Neuss, Germany, 41460
        • Recruiting
        • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NNC9836-0001

Participants will receive NNC9836-0001 subcutaneously.
Drug: NNC9836-0001

NNC9836-0001 will be administered subcutaneously.
Placebo Comparator: Placebo

Participants will receive placebo subcutaneously.
Drug: Placebo (NaCl)

Placebo (NaCl) will be administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Single ascending dose (SAD): Number of Treatment emergent adverse events (TEAEs)
Time Frame: From dosing (day 1) until week 26

Measured as events.
From dosing (day 1) until week 26
Multiple ascending dose (MAD): Number of TEAEs
Time Frame: From dosing (day 1) to week 34

Measured as events.
From dosing (day 1) to week 34

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: From predose day 1 to day 57

Measured as hours*nanograms per milliliter (h*ng/ml).
From predose day 1 to day 57
SAD:Cmax,SD: The maximum observed NNC9836-0001 plasma concentration after a single dose
Time Frame: From predose day 1 to day 57

Measured as nanograms per milliliter (ng/ml).
From predose day 1 to day 57
MAD: AUC0-28d,MD: The area under the NNC9836-0001 plasma concentration-time curve after multiple doses
Time Frame: From predose day 29 to day 57

Measured as hour*ng/mL.
From predose day 29 to day 57
MAD: Cmax,MD: The maximum observed NNC9836-0001 plasma concentration after multiple doses
Time Frame: From predose day 29 to day 57

Measured as ng/mL.
From predose day 29 to day 57

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 26, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 26, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN9836-8513
  • U1111-1328-6439 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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