Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 25 to 69

Safety test of NNC9836-0001 in adults with overweight/obesity or type 2 diabetes

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

Run by Novo Nordisk A/S · NCT07896109 · Data updated 2026-11-12

This study tests whether the new medicine NNC9836-0001 is safe and tolerable in adults who are overweight or have type 2 diabetes, compared to placebo.

More Diabetes Mellitus, Type 2 trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages25 Years to 69 Years
SexAll
Enrollment121 (estimated)
SponsorNovo Nordisk A/S
Industry-sponsored
Locations1 site (Neuss)
StatusRecruiting
StartedOctober 22, 2026
Main results expectedJuly 26, 2028
Study endsJuly 26, 2028
Registry record updatedNovember 10, 2026
Trial IDNCT07896109 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 25–69 with overweight/obesity (BMI 25–34.9 for healthy-weight group) or BMI 27–39.9 with type 2 diabetes, and who can provide informed consent.

Probably not a fit

Participants who do not benefit may experience adverse effects related to the study drug or receive no therapeutic effect from the treatment.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional trial to evaluate the safety and tolerability of NNC9836-0001 in two groups: metabolically healthy individuals with overweight or mild obesity and adults with type 2 diabetes. Participants are randomized to receive either NNC9836-0001 or placebo for a defined period. The study includes safety assessments, vital signs, labs, and ECGs to determine any adverse effects and suitable dosing. The trial is conducted at Profil Institut für Stoffwechselforschung GmbH in Neuss, sponsored by Novo Nordisk A/S. Enrollment targets adults aged 25 to 69 (depending on group) with specific BMI criteria per group.

Why it matters

Potential benefit: If successful, participants may gain insight into the safety profile of NNC9836-0001 and its potential for future diabetes treatment.

How similar studies have gone: Early-stage studies of similar anti-diabetes agents have shown tolerability signals, but this first-in-human trial with NNC9836-0001 is novel in its specific formulation and population.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Profil Institut für Stoffwechselforschung GmbH
    Neuss, Germany
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.