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Protein-based Tablet

Semaglutide Tablets for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 0 to 24 hours after dosing on day 80 and 90
Awards & highlights

Study Summary

This trial will test 2 different tablet versions of a known medicine to investigate how much of the active ingredient is in the blood. It will involve healthy male participants over 22 weeks.

Who is the study for?
Healthy men with a BMI between 22.0 and 31.9 kg/m^2 can join this study. They must be generally healthy as determined by medical history, physical exams, and various health tests. Men taking regular medications or those with conditions affecting safety or protocol adherence cannot participate.Check my eligibility
What is being tested?
The trial is testing two different tablet forms of Semaglutide to see how they affect the levels of active ingredient in the blood over two separate 10-day periods. Participants will try both versions randomly over about 22 weeks.See study design
What are the potential side effects?
While specific side effects are not listed for these tablets, common reactions may include digestive discomfort, headache, skin reactions at the tablet site, or allergic responses if sensitivity to Semaglutide exists.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 0 to 24 hours after dosing on day 80 and 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 0 to 24 hours after dosing on day 80 and 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adjusted AUC0-24h,sema; adjusted area under the semaglutide plasma concentration-time curve
Secondary outcome measures
Adjusted Cmax,0-24h,sema; adjusted maximum observed semaglutide plasma concentration
Adjusted tmax,0-24h,sema; time to adjusted maximum observed semaglutide plasma concentration
t½,sema; the terminal half-life of semaglutide

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sequence 2: Semagultide K then Semaglutide JExperimental Treatment1 Intervention
Oral semaglutide K will be administered in treatment period 1 followed by semaglutide J in treatment period 2.
Group II: Sequence 1: Semaglutide J then Semaglutide KExperimental Treatment1 Intervention
Oral semaglutide J will be administered in treatment period 1 followed by semaglutide K in treatment period 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2019
Completed Phase 4
~5160

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,414,948 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
106 Previous Clinical Trials
139,706 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I qualified to enroll in this research endeavor?

"In order to qualify for the trial, individuals must be healthy and between 18-64 years old. Currently, this clinical project is recruiting approximately 120 members."

Answered by AI

Are medical professionals currently signing up participants for this clinical test?

"Currently, this medical experiment is recruiting patients. Initially posted on September 28th 2023, the trial was last amended October 18th 2023 according to clinicaltrials.gov records."

Answered by AI

Is this investigation of any benefit to individuals aged over 55?

"The age range for this trial is 18 - 64. However, there are 66 studies available to those younger than the specified cutoff and 405 research opportunities for people aged 65 or more."

Answered by AI

Has the FDA given authorization for Sequence 1: Semaglutide J and Semaglutide K?

"Considering the limited efficacy and safety data available, our team at Power has estimated Sequence 1: Semaglutide J then Semaglutide K to be relatively unsafe with a score of 1."

Answered by AI

How many subjects are taking part in this research?

"Affirmative. Clinicaltrials.gov reveals that this medical experiment, which was originally posted on September 28th 2023, is currently recruiting participants. Approximately 120 people must be enrolled from 1 clinical site."

Answered by AI

Who else is applying?

What site did they apply to?
Novo Nordisk Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation III
2023. "A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation III". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06097390.
~76 spots leftby Apr 2025
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