A research study comparing how well different doses of the medicine NNC0519-0130 help people with excess body weight lose weight(NN9541-5015)

JRCT ID: jRCT2051230198

Registered date:11/03/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Obesity
• Date of first enrollment: 19/03/2024
• Target sample size: 36
• Countries of recruitment: United States,Japan,Australia,Japan
• Study type: Interventional
• Intervention(s): This is an interventional, 36-week, multi-national, multi-centre, randomised, 13 armed, parallel group, dose-finding phase 2 study. The study will be double-blinded within dose level of once weekly (QW) subcutaneously (s.c.) NNC0519-0130 and the corresponding volume-matched placebo arms. The active comparator arm with tirzepatide will be open label.

Outcome(s)

• Primary Outcome: Change from baseline in body weight (%)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

a) BMI >=27.0 kg/m2 with the presence of at least one weight-related co morbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.
b) BMI >= 30.0 kg/m2.

• Exclude criteria: History of type 1 or type 2 diabetes mellitus

Related Information

• Primary Sponsor: Oyatani Akihito
• Secondary ID(s): NCT06326060