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Protein-based Tablets

Part A: Oral semaglutide for Healthy Subjects

Phase 1
Waitlist Available
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 pre-dose pk sample (0 hours) at day 10 to pk sample 24 hours after dose administration
Awards & highlights

Study Summary

This trial will study the amount of active ingredients in 4 different tablet versions over 10 weeks in participants.

Eligible Conditions
  • Healthy Subjects
  • High Cholesterol
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from pre-dose pk sample (0 hours) at day 10 to pk sample 24 hours after dose administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and from pre-dose pk sample (0 hours) at day 10 to pk sample 24 hours after dose administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC0-24h,API,day10; area under the API plasma concentration-time curve from 0 to 24 hours after the 10th dose
Secondary outcome measures
Cmax,API,day10; maximum observed plasma concentration of API after the 10th dose
tmax, API,day10; time from the 10th dose to maximal observed plasma concentration of API

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part B: NNC0385-0434Experimental Treatment4 Interventions
Four different formulations of NNC0385-0434 are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days
Group II: Part A: Oral semaglutideExperimental Treatment4 Interventions
Four different formulations of oral semaglutide are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
FDA approved
Semaglutide
FDA approved
Semaglutide
FDA approved
Semaglutide
FDA approved
NNC0385-0434 B
2022
Completed Phase 1
~540
NNC0385-0434 C
2021
Completed Phase 1
~390
NNC0385-0434 D
2021
Completed Phase 1
~390
NNC0385-0434 E
2021
Completed Phase 1
~390

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
2,414,681 Total Patients Enrolled
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
56 Previous Clinical Trials
44,736 Total Patients Enrolled

Frequently Asked Questions

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

Is this research a novel endeavor in the field of medicine?

"Since 2018, Novo Nordisk A/S has sponsored research on Part A: Oral semaglutide. After a clinical trial involving 1387 participants, this medication gained its Phase 4 drug approval and is now being studied in 58 live trials across 772 locations and 55 countries."

Answered by AI

Is this trial currently accepting new participants?

"As per clinicaltrials.gov, this medical trial is currently recruiting participants and was first advertised on November 3rd 2021 with its latest update having been released on the 11th of November 2022."

Answered by AI

How many participants have enrolled in this clinical investigation?

"Affirmative, according to clinicaltrials.gov the aforementioned medical trial is actively recruiting participants as of now. It was first uploaded on November 3rd 2021 and last modified on November 11th 2022; with a total of 384 patients being sought out from one site."

Answered by AI

Could I be a potential candidate to partake in this medical experiment?

"Eligibility for this clinical trial necessitates that candidates have a specific cholesterol level and are between the ages of 18-55. A total of 384 individuals are needed to participate in the experiment."

Answered by AI

Does the criteria for entry into this research effort necessitate being over 25?

"This trial is limited to patients aged 18 through 55. For minors, there are 94 relevant clinical trials available and for seniors 781 alternative studies."

Answered by AI

In what cases is Part A: Oral semaglutide typically prescribed?

"Part A: Oral semaglutide is commonly prescribed to patients managing chronic weight issues. Moreover, this medication can be used in conjunction with a reduced-calorie diet, exercise regimen and other comorbid conditions related to obesity."

Answered by AI

Are there any documented precedents of trials that have implemented oral semaglutide?

"At present, 58 clinical trials are currently underway for Part A: Oral semaglutide with 27 of them in the third phase. Although most investigations take place in Loma Linda, California, there are 3,907 sites running studies dedicated to this medication."

Answered by AI

Has the FDA sanctioned Part A: Oral semaglutide?

"Our assessment on the safety of oral semaglutide was conservative, setting it as a 1. This is due to limited clinical data supporting both its efficacy and security at this time (Phase 1)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Research Study Looking at New Protein-based Tablets in Healthy Male Participants
2021. "A Research Study Looking at New Protein-based Tablets in Healthy Male Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05129891.
~112 spots leftby Apr 2025
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