A Research Study on How Well Different Doses of the Medicine NNC0662-0419 Help People Living With Overweight or Obesity
NCT ID: NCT07184632
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
220 participants
INTERVENTIONAL
2025-10-01
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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NNC0662-0419
Participants will be randomized to receive NNC0662-0419 subcutaneously (s.c.). The study will be conducted in 3 parts. Part A: Multiple ascending dose (MAD), Part B: Dose range finding (DFR) and Part C (2-week escalation).
NNC0662-0419
NNC0662-0419 will be administered subcutaneously.
Placebo
Participant will be randomized to receive placebo in:
The study will be conducted in 3 parts. Part A: Multiple ascending dose (MAD), Part B: Dose range finding (DFR) and Part C (2-week escalation).
Placebo
Placebo matched to NNC0662-0419 will be administered subcutaneously.
Interventions
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NNC0662-0419
NNC0662-0419 will be administered subcutaneously.
Placebo
Placebo matched to NNC0662-0419 will be administered subcutaneously.
Eligibility Criteria
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Inclusion Criteria
* Age at the time of signing the informed consent:
* For Part A:18-55 years (both inclusive)
* For Part B and Part C: 18-65 years (both inclusive)
* Body Mass Index (BMI) at screening (overweight should be due to excess adipose tissue, as judged by the investigator):
* For Part A: 27.0-39.9 kilogram per square meter(kg/m\^2) (both inclusive)
* For Part B and Part C:
1. Greater than or equal to (≥) 27.0 kg/m\^2 with the presence of at least one weight-related comorbidity (e.g. hypertension, dyslipidaemia, obstructive sleep apnoea or CV disease), or
2. Greater than or equal to (≥) 30.0 kg/m\^2
* 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.
* Willingness to obtain a high weight loss (greater than \[\>\] 25 percent \[%\]).
Exclusion Criteria
* Treatment with any compound containing Glucagon-Like Peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP) or amylin receptor agonism within 90 days before screening.
* Any condition, unwillingness or inability, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
* 2nd or 3rd degree atrioventricular-block, prolongation of the QRS complex over 120 millisecond (ms), or of the corrected QT interval by Fridericia (QTcF) calculation over 450 ms (females) or 430 ms (males), or any other clinically significant abnormal ECG results as judged by the investigator, at screening.
* Glycosylated haemoglobin (HbA1c) greater than or equal to (≥) 6.5% (48 millimoles per mole \[mmol/mol\]) at screening.
* History of type 1 or type 2 diabetes mellitus.
* Calcitonin greater than or equal to (≥) 50 nanogram per litre (ng/L) at screening.
18 Years
65 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Celerion, Phoenix
Tempe, Arizona, United States
Celerion, Lincoln
Lincoln, Nebraska, United States
Countries
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Central Contacts
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Other Identifiers
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U1111-1317-2736
Identifier Type: OTHER
Identifier Source: secondary_id
NN9662-8110
Identifier Type: -
Identifier Source: org_study_id
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