assignment
Recruiting

Effect of NNC0487‑0111 on Resting Energy Expenditure Following Weight Loss in Adults with Obesity: Randomized Placebo‑Controlled Trial with Low‑Calorie Diet Comparator

Trial ID
2025-522744-40-00
Protocol
NN9490-8152

Trial statistics

location_city
2
research sites
public
2
countries
medical_information
1
disease
person_search
2
investigators

Diseases & Conditions

Objectives

No primary or secondary objectives are specified in the provided source.

Participants

The sponsor did not provide information on the total number of participants. Both female and male individuals classified as Patients were eligible, with age categories indicated by codes 3 and 4, but specific age limits were not disclosed. All participants were required to have a diagnosis of Obesity. Selection was based on meeting the study’s inclusion criteria related to this condition; no additional lifestyle factors such as diet, physical activity, or habits were specified.

Plans and Procedures

The study is a Phase 3, multicenter, randomized, double-blind, controlled trial evaluating the impact of NNC0487-0111 on post‑weight‑loss energy metabolism in adults with obesity compared with a low‑calorie diet and a placebo. Recruitment begins 11 May 2026 and the trial is scheduled to conclude 7 Nov 2028, with each participant remaining in the study for approximately 12 months. After informed consent, a screening visit confirms eligibility, baseline measurements, and randomization to one of the three arms. Subsequent visits occur at weeks 4, 12, 24, 36, and 52 to assess safety, adherence, weight change, and metabolic parameters. The final visit at month 12 serves as the end‑of‑study assessment, including comprehensive laboratory testing and discontinuation of the investigational product. Participants may be withdrawn early for major protocol violations, emergence of serious adverse events, or inability to comply with study procedures.

Treatment

No information regarding the experimental medication(s), formulation, dosage, route of administration, frequency, comparator treatments, or compliance monitoring is provided in the source data.

Efficacy

Efficacy will be evaluated in adults with obesity enrolled in this phase 3 study.

Trial Status by Country

Country Status Start of Recruitment Planned Patients
Denmark DenmarkNot Yet Recruiting11 May 202660
The Netherlands The NetherlandsRecruiting11 May 2026
Netherlands Netherlands60

Sites & Investigators

Conditions Studied in This Trial