Phase 2Not yet recruitingAge-related condition
SEMAGONA – A randomized clinical trial
SEMAGONA: A randomized four-arm parallel group double-blind double dummy 52-week clinical trial comparing the effects of s.c. Semaglutide 2.4 mg once-weekly, i.m. testosterone undecanoate 1,000 mg every 13th week, combination of s.c. Semaglutide 2.4 mg once-weekly and i.m. testosterone undecanoate 1,000 mg every 13th week, and placebo on body composition and hypogonadal symptoms in men with obesity-associated functional hypogonadism
- Sponsor
- Region Hovedstaden (Academic or other)
- Enrolment
- 248 planned
- Conditions
- Functional hypogonadism
- Interventions
- Novo Nordisk has made a placebo for Wegovy; Grünenthal has made a placebo for Nebido; Wegovy 2.4 mg solution for injection in pre-filled syringe; NEBIDO 1000 mg/4 ml, solution injectable
- Ages
- adults, older adults
- Registry
- CTIS2026-527373-11-00
Full record on the EU Clinical Trials Information System
From the registry
Main objective: The main objective is to determine whether treatment with once weekly s.c. Semaglutide 2.4 mg + testosterone (1000 mg every 13 week) can alleviate the loss of fat free mass (%) in obese men with functional hypogonadism compared with placebo.
Primary outcomes
- The primary endpoint is difference in fat free mass % evaluated by DXA at the end of the intervention (week 52) in Semaglutide + testosterone- compared to placebo-treated men.
History
Registered