NCT05268237
Safety, Tolerability and Preliminary Efficacy of Sublingual Liraglutide in Patients With Type 2 Diabetes Mellitus
Recruiting · Phase 1, Phase 2 · Biolingus · registry updated 2025-02-06
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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).
Inclusion
- Males and females aged 18-65 years (inclusive)
- Body mass index (BMI) 18-35 kg/m2, inclusive
- Normal blood pressure or well managed hypertension (systolic blood pressure \<160mmHg, diastolic blood pressure \<100 mmHg)
- Confirmed diagnosis of T2DM (by repeated laboratory findings) for at least 1 year.
- Subjects under glycemic control on a stable dose of metformin (within the standard of care dose range up to 2 g daily) for at least 2 months prior to enrolment or those who manage their condition only by diet/exercise.
- For subjects on a stable dose of concomitant metformin for at least 2 months prior to enrolment, the subject's dose of metformin will be required to remain constant until at least the completion of MMTT on the final dosing day. Subjects whose concomitant glucose lowering medication changes during the dosing phase of the study will be discontinued and may be replaced.
Exclusion
- Pregnant or lactating, or intending to become pregnant within 30 days after last dose of study drug.
- Participation in a clinical trial within 30 days before enrolment; use of any experimental oral therapy within 30 days or 5 half-lives prior to enrolment, whichever is greater; or use of any biologic therapy within 12 weeks or 5 half-lives prior to enrolment, whichever is greater. Subjects who have received an experimental therapy that has no half-life, such as a vaccine, should have completed that therapy at least 30 days prior to enrolment.
- Any vaccine 2 weeks prior to first study drug administration until 2 weeks after the last dose, with the exception of current seasonal influenza vaccination.
- Use of any weight loss agent within the preceding 4 weeks.
- Surgery or hospitalization during the 4 weeks prior to screening.
- Planned procedure or surgery during the study.