Sequence A: Semaglutide J-Semaglutide C-Semaglutide J for Healthy Subjects

Novo Nordisk Investigational Site, Montreal, Canada
Healthy SubjectsSemaglutide J - Drug
Eligibility
18 - 64
All Sexes

Study Summary

This trial tests different versions of an investigational medicine, semaglutide, in up to 260 participants to measure the amount of semaglutide in the blood. Participants take tablets daily for 18 weeks and are randomized to 1 of 4 groups. No food/water 2 hrs before dose & no other meds 14 days prior. Women can't be pregnant/breastfeeding.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Study Objectives

1 Primary · 2 Secondary · Reporting Duration: From 0 to 24 hours after dosing on days 70, 98 and 126

Day 70
AUC0-24h,semaglutide,SS; area under the semaglutide plasma concentration-time curve during a dosing interval at steady state
Cmax,0-24h.semaglutide,SS; maximum observed plasma concentration of semaglutide at steady state
tmax,0-24h,semaglutide,SS; Time to maximum semaglutide plasma concentration at steady state

Trial Safety

Phase-Based Safety

1 of 3

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1
Sequence A
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

4 Treatment Groups

Sequence A: Semaglutide J-Semaglutide C-Semaglutide J
1 of 4
Sequence C: Semglutide J-Semaglutide J-Semaglutide C
1 of 4
Sequence B: Semaglutide C-Semaglutide J-Semaglutide J
1 of 4
Sequence D: Semaglutide J-Semaglutide C-Semaglutide J
1 of 4

Experimental Treatment

260 Total Participants · 4 Treatment Groups

Primary Treatment: Sequence A: Semaglutide J-Semaglutide C-Semaglutide J · No Placebo Group · Phase 1

Sequence A: Semaglutide J-Semaglutide C-Semaglutide JExperimental Group · 2 Interventions: Semaglutide J, Semaglutide C · Intervention Types: Drug, Drug
Sequence C: Semglutide J-Semaglutide J-Semaglutide CExperimental Group · 2 Interventions: Semaglutide J, Semaglutide C · Intervention Types: Drug, Drug
Sequence B: Semaglutide C-Semaglutide J-Semaglutide JExperimental Group · 2 Interventions: Semaglutide J, Semaglutide C · Intervention Types: Drug, Drug
Sequence D: Semaglutide J-Semaglutide C-Semaglutide JExperimental Group · 2 Interventions: Semaglutide J, Semaglutide C · Intervention Types: Drug, Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from 0 to 24 hours after dosing on days 70, 98 and 126

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,437 Previous Clinical Trials
2,332,164 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
65 Previous Clinical Trials
81,422 Total Patients Enrolled

Eligibility Criteria

Age 18 - 64 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your BMI must be between 23.0 and 34.9 kg/m^2, inclusive, at the time of assessment.
References

Frequently Asked Questions

Is the age restriction for participation in this experiment above or below 55 years of age?

"The current study stipulates that participants are between 18 and 64 years old. However, there are 54 trials for younger patients and 370 dedicated to seniors." - Anonymous Online Contributor

Unverified Answer

What criteria must a person satisfy in order to be accepted into this research?

"To be eligible for this experiment, potential participants must have no underlying health conditions and lie between 18 - 64 years old. In total, there are 260 slots to fill in the trial." - Anonymous Online Contributor

Unverified Answer

Is the enrollment period for this trial open at present?

"Clinicaltrials.gov states that this particular medical study is no longer enrolling participants, having opened and closed on March 15th and 13th of 2023 respectively. However, there are still 827 other trials actively seeking volunteers at the moment." - Anonymous Online Contributor

Unverified Answer

Has the FDA sanctioned Sequence A: Semaglutide J-Semaglutide C-Semaglutide J?

"Due to it being a Phase 1 trial, with limited data on efficacy and safety, our group at Power rated Sequence A: Semaglutide J-Semaglutide C-Semaglutide J as having a low level of safety (1 out of 3)." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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