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. |
| New Dosage | NCT04287179 ↗ | SUSTAIN SWITCH: A Research Study to Compare Two Dose Schedules of Semaglutide Taken Once Weekly in People With Type 2 Diabetes | Withdrawn | Novo Nordisk A/S | Phase 3 | 2020-03-09 | This study compares the effect and safety of 2 dose schedules for semaglutide (study medicine) in people with type 2 diabetes previously treated with a diabetes medicine similar to semaglutide. The study will also evaluate the use of a new pen-injector for semaglutide used to inject medicine under the skin, at a new dose of 2 mg. People taking part in the study will take this medicine together with their current diabetes tablets other than semaglutide. Participants will either get a start dose of 0.25 mg semaglutide or 0.50 mg semaglutide, and the dose will be gradually increased to 2.0 mg semaglutide - which treatment is decided by chance. Participants will inject semaglutide under the skin once a week, any time of the day. When the dose reaches 2.0 mg semaglutide, participants will inject the medicine with a new type of pen-injector. The study will last for about 24 weeks. Participants will have 9 visits and 1 phone call with the study doctor. At 9 visits participants will have blood taken and at 2 visits they will have eye examination done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Women who are able to get pregnant will be checked 10 times for pregnancy via urine tests. |
| New Dosage | NCT06083675 ↗ | Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes | Withdrawn | Novo Nordisk A/S | Phase 3 | 2024-01-26 | This study compares the medicines semaglutide with empagliflozin or metformin in people with newly diagnosed type 2 diabetes. This study will look mainly at how well participant's blood sugar and body weight are controlled when they are taking the study medicines. Participants will either get semaglutide tablets, empagliflozin tablets or metformin tablets. Which treatment participants will get is decided by chance. Currently, doses of 3 milligram (mg), 7 mg and 14 mg semaglutide tablets (Rybelsus) can be prescribed in some countries. 25 mg and 50 mg semaglutide tablets are new doses. 10 mg and 25 mg empagliflozin tablets (Jardiance) can be prescribed in some countries. 500 mg metformin tablets (STADA) can be prescribed in some countries. Participants will get 1 to 4 tablets per day for 104 weeks. The study will last for about 2 years and 7 weeks (111 weeks). Participants should not have been treated for weight management 90 days before screening or never been treated with any medicine for type 2 diabetes (except diabetes during pregnancy) before screening. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. |
| >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. |
| NCT00851773 ↗ | Safety, Tolerability, and Profile of Action of Drug in the Body of NN9535 in Healthy Male Japanese and Caucasian Subjects | Completed | Novo Nordisk A/S | Phase 1 | 2009-02-01 | This trial is conducted in Europe. The aim of this clinical trial is to assess and compare the safety and tolerability, as assessed by adverse events after multiple subcutaneous doses of NN9535 in healthy male Japanese and Caucasian subjects. |
| NCT01272973 ↗ | Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 in Healthy Male Subjects | Completed | Novo Nordisk A/S | Phase 1 | 2011-01-01 | This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of NN9924 in healthy male subjects |
| NCT01324505 ↗ | Effect of Oral Contraceptives After Administration of Semaglutide in Subjects With Type 2 Diabetes | Completed | Novo Nordisk A/S | Phase 1 | 2011-03-01 | This clinical trial is conducted in Europe. The purpose of the trial is to investigate the influence on the pharmacokinetics (the rate at which the trial drug is eliminated from the body) of an oral contraceptive combination drug after multiple administration of semaglutide in female subjects with type 2 diabetes. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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