A Research Study of How Safe a New Medicine Called NNC0519 0130 is and to Test Its Effect in People Living With Excess Body Weight With or Without Type 2 Diabetes

Last updated: April 8, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Not Recruiting

Phase

1

Condition

Diabetes And Hypertension

Diabetes Prevention

Obesity

Treatment

NNC0519-0130

Placebo

Clinical Study ID

NCT06567041
NN9541-8116
2024-512719-28
U1111-1305-5164
  • Ages 18-55
  • All Genders

Study Summary

A new study medicine called NNC0519-0130 to improve treatment options for people living with excess body weight, with or without type 2 diabetes. The purpose of the study is to investigate potential side effects and blood levels of NNC0519-0130, as well as changes in body weight, blood sugar levels, and heart activity. The study consists of two groups, with participants receiving either the study medicine (NNC0519-0130) or a placebo. Which treatment participants get is decided by chance and they can only participate in one group. Participants will be given the study medicine once weekly, and it should be taken on the same day each week. The treatment duration depends on the group participants are enrolled in, with the study lasting for 37 weeks for Group 1 and 34 weeks for Group 2.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Informed consent obtained before any study-related activities. Study-relatedactivities are any procedures that are carried out as part of the study, includingactivities to determine suitability for the study.

  • Male or female of non-childbearing potential.

  • Age 18-55 years (both inclusive) at the time of signing the informed consent.

  • Considered eligible based on the medical history, physical examination, and theresults of vital signs, electrocardiogram and clinical laboratory tests performedduring the screening visit, as judged by the investigator.

Participants with obesity only:

  • Body mass index between 30.0 kilogram per meter square (kg/m^2) and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, asjudged by the investigator.

Participants with type 2 diabetes with either overweight or obesity:

  • Body mass index between 27.0 kg/m^2 and 39.9kg/m^2 (both inclusive) at screening.Overweight should be due to excess adipose tissue, as judged by the investigator.

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

  • Glycated haemoglobin (HbA1c) in the range of 6.5 percentage (%) (inclusive) and 9.5% (inclusive).

Exclusion

Exclusion Criteria:

  • Any condition, except T2D and hypertension, which in the investigator's opinionmight jeopardise participant's safety or compliance with the protocol.

  • Presence or history of any clinically relevant respiratory, metabolic, renal,hepatic, gastrointestinal, endocrinological conditions (except diabetes mellitus andhypertension).

  • Presence or history of cardiovascular disease including stable and unstable anginapectoris, myocardial infarction, transient ischaemic attack, stroke, cardiacdecompensation, clinically significant arrhythmias or clinically significantconduction disorders.

  • Participant is breastfeeding.

Participants with obesity only:

  • HbA1c ≥ 6.5 % (48 millimoles per mol [mmol/mol]) at screening.

Participants with type 2 diabetes with either overweight or obesity:

  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verifiedby a fundus examination performed within 90 days before screening or in the periodbetween screening and randomisation. Pharmacological pupil-dilation is a requirementunless using a digital fundus photography camera specified for non-dilatedexamination.

  • Recurrent severe hypoglycaemia within the last year as judged by the investigator.

  • Known hypoglycaemic unawareness as indicated by the investigator according toClarke's questionnaire question 8.

Study Design

Total Participants: 64
Treatment Group(s): 2
Primary Treatment: NNC0519-0130
Phase: 1
Study Start date:
August 07, 2024
Estimated Completion Date:
December 03, 2025

Connect with a study center

  • Parexel International GmbH

    Berlin, 14050
    Germany

    Site Not Available

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