CLINICAL TRIALS PROFILE FOR SEMAGLUTIDE
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505(b)(2) Clinical Trials for SEMAGLUTIDE
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| New Formulation | NCT03638778 ↗ | Research Study Comparing Different Tablets With the Study Medicine Semaglutide in Healthy Men | Completed | Novo Nordisk A/S | Phase 1 | 2018-08-17 | This study looks at different tablets with a new study medicine called semaglutide. It is to treat diabetes. The aim of the study is to find out how much study medicine from 4 different tablets is taken up in the body. Participants will either get semaglutide in the tablet currently being studied in large studies, or 1 of the 3 new tablets that also contains 'semaglutide' - which treatment participants get is decided by chance. The tablet version of study medicine is a new medicine that cannot be prescribed. Semaglutide can be prescribed as injections for the treatment of diabetes in some countries. Participants will get 1 tablet per day for 10 days. The tablets should be taken in the morning by mouth together with half a glass of water. After dosing participants have to wait 30 minutes before participants may eat or drink. The study will last up to 70 days. Participants will have 17 clinic visits with the study doctor. Some of the visits are overnight stays. Participants will have blood tests at every visit. |
| New Formulation | NCT04097600 ↗ | A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets | Completed | Novo Nordisk A/S | Phase 1 | 2019-09-30 | In this study two different tablets for oral use of a known investigational medicinal product, called semaglutide, will be tested. One is the current formulation and the other one is a new formulation of semaglutide. Both will be administered as a tablet and are for the treatment of diabetes. Currently, semaglutide is only prescribed as injections for the treatment of diabetes in some countries. The aim of this study is to find out if the dosage strength of the current formulation of semaglutide can be reduced in the new tablet formulation. For this purpose, it will be measured how much semaglutide is taken up in the body from the two (2) different tablet formulations each with three (3) different dosage strengths. The tablet version of the study medicine is a new medicine that cannot yet be prescribed. Participants will either get semaglutide in the current tablet formulation previously tested in many large studies, or get the tablet that contains semaglutide in a new formulation - which treatment is decided by chance. Participants will get one tablet per day over 4 weeks in each of the 3 treatment periods (i.e. treatment in a total of 12 weeks). The tablets should be taken in the morning together with half a glass of water (120 mL), after an overnight fast of at least 6 hours (no food or drinks). Furthermore, water is not allowed from 2 hours before dosing. After dosing participants must wait 30 minutes before they may eat or drink. At home, participants must take their breakfast 30-45 minutes after dosing. |
| New Formulation | NCT04109508 ↗ | A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (C) Semaglutide Tablets | Completed | Novo Nordisk A/S | Phase 1 | 2019-10-02 | In this study two different tablets for oral use of a known investigational medicinal product, called semaglutide, will be tested. Besides semaglutide, the current version of the tablet contains 300 mg SNAC and 3 helping agents, while the new version of the tablet contains 300 mg SNAC and only one helping agent. Both are for the treatment of diabetes. Currently, semaglutide is only prescribed as injections for the treatment of diabetes in some countries. Semaglutide cannot yet be prescribed as a tablet. The aim of this study is to find out if the dosage strength of the current formulation of semaglutide can be reduced in the new tablet formulation. For this purpose, it will be measured how much semaglutide is taken up in the body from the two (2) different tablet formulations each with three (3) different dosage strengths. Participants will get semaglutide in the current tablet formulation and in a new formulation - in which order they receive the two different formulations is decided by chance. Participants will get one tablet per day over 4 weeks in each of the 3 treatment periods (i.e. treatment for a total of 12 weeks). The tablets should be taken in the morning together with half a glass of water (120 mL), after an overnight fast of at least 6 hours (no food or drinks). Furthermore, water is not allowed from 2 hours before dosing. After dosing participants must wait 30 minutes before they may eat or drink. At home, they must take their breakfast 30-45 minutes after dosing. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for SEMAGLUTIDE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00696657 ↗ | A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide | Completed | Novo Nordisk A/S | Phase 2 | 2008-06-03 | This trial was conducted in Europe,Asia and Africa. Study participants were randomised evenly to treatment with semaglutide (0.1 mg QW - 1.6 mg QW, 6 treatment arms, placebo or liraglutide (1.2 mg QD, or 1.8 mg QD).Treatment allocation to semaglutide or placebo was double-blind, whereas liraglutide treatment was administered open-label.Primary efficacy parameter was HbA1c and the treatment duration was 12 weeks. |
| NCT00813020 ↗ | A Clinical Trial Investigating the Comparison of Three Different Concentrations of NN9535 in Healthy Male Subjects | Completed | Novo Nordisk A/S | Phase 1 | 2009-01-01 | This trial is conducted in Europe. The aim of this clinical trial is to investigate whether differences exist between three different concentrations of the drug, NN9535, administered in healthy male subjects in equal doses. |
| NCT00833716 ↗ | Effect of Renal Impairment on the Pharmacokinetics of NN9535 | Completed | Novo Nordisk A/S | Phase 1 | 2009-02-02 | This trial is conducted in the United States of America (USA). The aim of this clinical trial is to investigate how different degrees of renal impairment (mild, moderate, severe and end-stage renal disease) affect the pharmacokinetics of NN9535. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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