Trials / Recruiting
RecruitingNCT05268237
Safety, Tolerability and Preliminary Efficacy of Sublingual Liraglutide in Patients With Type 2 Diabetes Mellitus
A Phase Ib/IIa, Single Ascending Dose Study of the Safety, Tolerability and Preliminary Efficacy of Sublingual Liraglutide in Patients With Type 2 Diabetes Mellitus
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- Biolingus · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase Ib/IIa, single ascending dose study of the safety, tolerability and preliminary efficacy of sublingual (SL) Liraglutide in patients with type 2 diabetes mellitus (T2DM).
Detailed description
This Phase Ib/IIa study of SL liraglutide will be conducted at the Phase 1 Clinical Trial Center, Prince of Wales Hospital, Hong Kong. Study subjects will be patients with T2DM who have not previously received liraglutide. The study seeks to document the utility of a SL formulation of the approved active ingredient liraglutide, currently marketed in a subcutaneous (SC) formulation as Victoza®.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Liraglutide | Sublingual or subcutaneous liraglutide |
| DRUG | Placebo | Sublingual placebo |
Timeline
- Start date
- 2023-04-25
- Primary completion
- 2025-12-01
- Completion
- 2026-03-01
- First posted
- 2022-03-07
- Last updated
- 2025-02-06
Locations
1 site across 1 country: Hong Kong
Source: ClinicalTrials.gov record NCT05268237. Inclusion in this directory is not an endorsement.