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Research Study Comparing New Tablets of Semaglutide in New Doses, in Healthy People

NCT04524832 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2023-10-10

No results posted yet for this study

Summary

In this study a known investigational medicinal product called semaglutide will be tested in four different tablet versions. In addition to semaglutide, the different tablet versions C, D, E and F contain different helping agents in different amounts. All tablet versions have a helping agent called SNAC. All tablet versions are tested for the treatment of type 2 diabetes. Recently the European Medicines Agency approved semaglutide in tablet form and currently, tablets in the doses 3 mg, 7 mg and 14 mg can be prescribed in some countries. The main aim of this study is to test oral semaglutide doses of 25 mg and 50 mg. These are higher dosages of oral semaglutide than can be prescribed today. With the 50 mg dose, we expect the amount of semaglutide in the blood to be higher than what has been tested before. Further aims of this study are to find an optimal version for the semaglutide tablets, and to examine the safety and tolerability of the different tablet versions. For this purpose, the amount of semaglutide in the blood will be measured after taking different semaglutide tablets, in different doses. The version of the tablet participants will receive (i.e. the treatment arm participants will be assigned to) is decided by chance.

In treatment periods 1 and 2 participants will receive one tablet daily over 2 weeks for each period. For treatment periods 3 to 5 participants will receive one tablet daily over 4 weeks for each period (participants may get 2 tablets per day in treatment period 5). This means that treatment will take 16 weeks in total. The tablets should be taken in the morning together with no more than half a glass of water (120 mL), after an overnight fast of at least 6 hours (no food or drinks). Water is also not allowed from 2 hours before dosing. After dosing participants must wait 30-35 minutes before they eat or drink. At home, participants must take their breakfast 30-45 minutes after dosing.

No oral medication (which are taken by mouth) can be taken from 2 hours before and until 30 minutes after each dosing with semaglutide. The study can last for up to 24 weeks for each participant. This includes a screening period (up to 3 weeks), a treatment period (16 weeks) and a follow-up visit (5 weeks after the last dosing). Participants will have 11 clinic visits with the study doctor. Some of the visits include overnight stays. Participants will have blood tests at every visit. Participants must be healthy and have a body mass index (BMI) between 21.0 and 29.9 kg/m\^2 For women: Women cannot take part in this study if they are pregnant, breast-feeding or plan to become pregnant during the study period.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Oral semaglutide

Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 16 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Reporting Anchor and Disclosure 1452 · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-29
Primary Completion
2022-02-25
Completion
2022-02-25

Countries

  • Germany

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04524832 on ClinicalTrials.gov