Efficacy and safety of cagrilintide s.c. 2.4 mg in combination with semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) once-weekly in participants with overweight or obesity

JRCT ID: jRCT2051220121

Registered date:25/11/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Obesity
• Date of first enrollment: 07/11/2022
• Target sample size: 250
• Countries of recruitment: Argentina,Japan,Belgium,Japan,Bulgaria,Japan,Canada,Japan,Denmark,Japan,Finland,Japan,France,Japan,Germany,Japan,Mexico,Japan,Netherlands,Japan,South Korea,Japan,Spain,Japan,Taiwan,Japan,Turkey,Japan,United Kingdom,Japan,United States,Japan,Australia,Japan,India,Japan,Italy,Japan,Poland,Japan,Russia,Japan,Serbia,Japan,South Africa,Japan
• Study type: Interventional
• Intervention(s): The trial is an interventional 68-week (main phase) randomised, double-blind, placebo- and active-controlled, four arm, parallel group, multicentre, multinational clinical study comparing CagriSema s.c.2.4mg/2.4 mg once-weekly with semaglutide s.c. 2.4 mg and cagrilintide s.c. 2.4 mg and placebo, all as an adjunct to a reduced-calorie diet and increased physical activity, in participants with overweight or obesity. The study will also include a 97-week two arm, off-treatment extension phase.

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: BMI >= 30.0 kg/m2 or b) BMI >= 27.0 kg/m2 with the presence of at least one weight related comorbidity including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
• Exclude criteria: History of type 1 or type 2 diabetes mellitus

Related Information

• Primary Sponsor: Oyatani Akihito
• Secondary ID(s): NCT05567796