Investigation of Safety, Tolerability, Pharmacokinetic and Pharmacodynamics of Single Administrations of NNC9733-0001 in Healthy Participants and in Participants With Type 2 Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study is testing a new medicine that might help treat people with type 2 diabetes. The study is conducted to see if the new medicine can lower high sugar levels in the blood. The purpose of the study is to see if the new study medicine is safe and how well is tolerated by the body. There will be two groups of partici-pants in this study: healthy participants and participants with type 2 diabetes. Participant will either get study medicine (NNC9733-0001) or placebo (a treatment that has no active medicine in it). Which treatment the participant gets is decided by chance. Which dose (strength) the participant get is determined by when participant enter the study. Participant will get one dose which will be injected into the area around abdomen (belly) by the medical staff. The number of injections (up to 4 injections) will depend on the group the participant is assigned to. Larger doses require multiple injections. The study will last for about 40 weeks (10 months).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: t
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⁃ 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 eligibility for the study.

• Male, or female of nonchildbearing potential

⁃ Healthy participants

• Age 18-45 years (both inclusive) at the time of signing the informed consent.

• Body Mass Index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m\^2) (both inclusive) at screening.

• Glycosylated haemoglobin (HbA1c) less than or equal to (≤) 6.4 percent (%) (47 millimoles per mole (mmol/mol)) at screening.

• Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, Electrocardiography (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator.

⁃ Participants with T2DM

• Age 18-64 years (both inclusive) at the time of signing the informed consent.

• BMI between 20.0 and 34.9 kg/m\^2 (both inclusive) at screening.

• HbA1c 6.5-8.5% (47.5-69.4 mmol/mol) at screening.

• Diagnosed with type 2 diabetes mellitus (T2DM) greater than or equal to (≥) 180 days before screening.

• Stable daily dose(s) of metformin within 90 days before screening.

Locations
Other Locations
Germany
Profil Institut für Stoffwechselforschung GmbH
RECRUITING
Neuss
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: 2025-11-25
Estimated Completion Date: 2027-11-12
Participants
Target number of participants: 72
Treatments
Experimental: NNC9733-0001
Participants will be administered a single dose of NNC9733-0001 in a dose escalated manner.
Experimental: Placebo
Participants will be administered a single dose of matching NNC9733-0001 placebo in a dose escalated manner.
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov