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A Study Investigating Safety, Tolerability and Efficacy of Once-weekly NNC0662-0419 in Participants Living With Overweight or Obesity

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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:

• 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

∙ 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 \[%\]).

Locations
United States
Arizona
Celerion, Phoenix
RECRUITING
Tempe
Nebraska
Celerion, Lincoln
RECRUITING
Lincoln
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 220
Treatments
Experimental: 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).
Placebo_comparator: 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).
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov