New weekly shot aims to tackle obesity and diabetes
NCT ID NCT06567041
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a new medicine, NNC0519-0130, given as a weekly injection to help people with obesity or type 2 diabetes. The main goals were to check for side effects and measure how the drug moves through the body. 82 participants were randomly assigned to get either the study drug or a placebo, and researchers tracked changes in body weight, blood sugar, and heart activity over several months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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82 people
The number who actually took part.
- Started
-
Aug 2024
- Finished
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Dec 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 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 the results of vital signs, electrocardiogram and clinical laboratory tests performed during 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, as judged 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 before screening. * Glycated haemoglobin (HbA1c) in the range of 6.5 percentage (%) (inclusive) and 9.5% (inclusive). Exclusion Criteria: * Any condition, except T2D and hypertension, which in the investigator's opinion might 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 and hypertension). * Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction 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. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. * Recurrent severe hypoglycaemia within the last year as judged by the investigator. * Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Parexel International GmbH
Berlin, 14050, Germany
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Other studies related to the condition(s) this trial covers.
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