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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-12-01

Brief Summary

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This study tests how well different doses of the medicine NNC0662-0419 help people living with overweight or obesity. The purpose of the study is to find out if NNC0662-0419 is safe and effective for treating people living with overweight or obesity. There are 2 study treatments in this study, participants will get either NNC0662-0419, the treatment being tested or placebo, a treatment that has no active medicine in it. NNC0662-0419 is a new medicine which cannot be pre-scribed by doctors but has previously been tested in humans.

Detailed Description

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Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Sponsor staff involved in the clinical trial is masked according to company standard procedures.

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).

Group Type EXPERIMENTAL

NNC0662-0419

Intervention Type DRUG

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).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matched to NNC0662-0419 will be administered subcutaneously.

Interventions

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NNC0662-0419

NNC0662-0419 will be administered subcutaneously.

Intervention Type DRUG

Placebo

Placebo matched to NNC0662-0419 will be administered subcutaneously.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female (sex at birth).
* 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

* Known or suspected hypersensitivity to study intervention(s) or related products.
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Celerion, Lincoln

Lincoln, Nebraska, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Novo Nordisk

Role: CONTACT

(+1) 866-867-7178

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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