Semaglutide for Obesity

Phase 4

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

Body weight greater than 60 kg at screening

Age 12 to less than 15 years at the time of signing the informed consent

Must not have

Prepubertal status (Tanner stage 1)

History of type 1 or type 2 diabetes mellitus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from 1.5 years to 3 years and end of continued treatment phase (up to 6 years)

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is looking at whether semaglutide can help teenagers who are overweight to lose weight and keep it off. Everyone in the study will receive semaglutide as a weekly injection for at

Who is the study for?

This trial is for teenagers with excess body weight who are interested in losing and maintaining weight loss. Participants will receive weekly injections of semaglutide for at least 3 years. Specific eligibility criteria details were not provided.

What is being tested?

The study focuses on the effectiveness of semaglutide, administered through weekly injections, in helping overweight adolescents lose and maintain their weight over a minimum period of three years.

What are the potential side effects?

Potential side effects from semaglutide may include digestive issues like nausea or diarrhea, possible injection site reactions, and changes in appetite. More specific side effect information was not provided.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My body weight is over 60 kg.

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I am between 12 and 14 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not started puberty (Tanner stage 1).

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I have a history of diabetes (type 1 or 2).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from 1.5 years to 3 years and end of continued treatment phase (up to 6 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from 1.5 years to 3 years and end of continued treatment phase (up to 6 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from 1.5 years to 3 years and end of continued treatment phase (up to 6 years) for reporting.