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RECRUITING Phase 3

A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight

NCT07253285 · View on ClinicalTrials.gov ↗

Study Summary

This study will look at how well CagriSema and cagrilintide help children and adolescents with excess body weight lose weight. The study has 2 parts: main and extension study. In the main study, participants will either get CagriSema (a new study drug), cagrilintide (a new study drug), semaglutide (a drug that doctors can already prescribe to adolescents and adults) or placebo (a placebo looks like the treatment being tested, but doesn't have any active ingredients in it). Which treatment participants will get is decided by chance. Participants who get semaglutide in the main study will not take part in the extension study. If participants take part in the extension study, they will get either CagriSema or cagrilintide in this part of the study. Like all drugs, the study drugs may have side effects. The total time participants will be in the main study is about 1 year and 6 months. If participants take part in the extension study, the total time is about 4 years and 10 months.

Conditions Studied

Interventions

  • DRUG Semaglutide
  • DRUG Cagrilintide
  • DRUG Placebo cagrilintide
  • DRUG Placebo semaglutide

Study Locations (20)

Georgia

  • Children's Healthcare Atlanta — Atlanta
  • Columbus Research Foundation — Columbus
  • Accel Research Sites-NeuroStudies — Decatur
  • Eastside Bariatric and Gen Surg — Snellville

Florida

  • Encore Medical Research LLC — Hollywood
  • Jacksonville Ctr for Clin Res — Jacksonville
  • Encore Medical Research of Weston — Weston

New York

  • UBMD Physicians Group - Pediatrics - Conventus — Buffalo
  • SUNY Upstate Medical Univ - Syracuse — Syracuse
  • Advantage Clinical Trials — The Bronx

Minnesota

  • University of Minnesota — Minneapolis
  • AES Minneapolis DRS — Richfield

California

  • Neighborhood Healthcare — Escondido

Idaho

  • Solaris Clinical Research — Meridian

Indiana

  • IU Health - Riley Physicians Endo-Diab — Indianapolis

Kansas

  • Cotton O'Neil Clinical Research Center — Topeka

Trial Details

FieldValue
Enrollment Target 460 participants
Start Date 2026-01-08
Est. Completion 2033-09-20
Phase Phase 3

Sponsor

Novo Nordisk A/S

189 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07253285

The ClinicalTrials.gov registry entry for NCT07253285 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 460 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 189 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 4 interventions — of which Semaglutide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07253285 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Georgia, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07253285 about?

NCT07253285 is a clinical study titled "A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight". This study will look at how well CagriSema and cagrilintide help children and adolescents with excess body weight lose weight. The study has 2 parts: main and extension study. In the main study, participants will either get CagriSema (a new study drug), cagrilintide (a new study drug), semaglutide (...

What is the current status of trial NCT07253285?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 460 participants. The study started on 2026-01-08. Estimated completion is 2033-09-20.

What conditions does trial NCT07253285 study?

This clinical trial studies the following conditions: Obesity, Overweight. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07253285?

The interventions under investigation include: Semaglutide (DRUG), Cagrilintide (DRUG), Placebo cagrilintide (DRUG), Placebo semaglutide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07253285?

This trial is sponsored by Novo Nordisk A/S, which has 189 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07253285 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Idaho, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial