WHO ICTRP trial
The purpose of this study is to evaluate the effect and safety of tirzepatide in…
JPRN-jRCT2031220154 · Japan Primary Registries Network (JPRN) · Not Recruiting
Key facts
| Trial ID | JPRN-jRCT2031220154 |
|---|---|
| Public title | The purpose of this study is to evaluate the effect and safety of tirzepatide in participants with obstructive sleep apnea and obesity who are both unwilling or unable to use Positive Airway Pressure (PAP) therapy in GPI-1 |
| Scientific title | A Master Protocol to Investigate the Efficacy and Safety of Tirzepatide Once Weekly in Participants who have Obstructive Sleep Apnea and Obesity: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-OSA) ISA1 (GPI1): Participants with OSA Unwilling or Unable to use PAP Therapy… |
| Primary sponsor | Masaki Takeshi |
| Registry | Japan Primary Registries Network (JPRN) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | 3 |
| Countries | Australia;Japan;Brazil;Japan;China;Japan;Czech Republic;Japan;Germany;Japan;Mexico;Japan;United States;Japan;Taiwan;Japan |
| Conditions | Sleep Apnea,Obesity |
| Interventions | -Experimental: Tirzepatide Maximum Tolerated Dose Participants will receive a low dose and then increase to a maximum tolerated dose 1 or dose 2 subcutaneously (SC). -Placebo Comparator: Placebo Participants will receive placebo SC |
| Registration date | Jun 22, 2022 |
| Target size | 206 |
| Secondary IDs | NCT05412004 |
| Registry page | jrct.niph.go.jp |
At a glance
- No Results available
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: