Clinical trial

A Research Study on How Well Different Doses of the Medicine NNC0662-0419 Help People Living With Overweight or Obesity

Active, not recruiting · Phase 2 · 1 countries · Registry ID NCT07184632

Active, not recruitingPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionOverweight, Obesity

Full registry criteria

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.

Treatments and study arms

NNC0662-0419

Drug

NNC0662-0419 will be administered subcutaneously.

Placebo

Drug

Placebo matched to NNC0662-0419 will be administered subcutaneously.

Primary outcomes

Part A: Number of treatment-emergent adverse events (TEAE)From baseline (week 0) to end of study (up to week 44)

Measured as number of events.

Part B: Relative change in body weightFrom baseline (week 0) to end of treatment (week 36)

Measured as percentage (%).

Part C: Occurrence of premature treatment discontinuation (Yes/No)At end of treatment (week 24)

Measured as count of participants.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Celerion, Lincoln🇺🇸 Lincoln, Nebraska, United States
Celerion, Phoenix🇺🇸 Tempe, Arizona, United States