Treatment of obesity in adolescents through stomach injections of botox

Treatment of obesity in adolescents by endoscopic injection of Botulinum toxin A - A randomised, double blind, placebo-controlled phase II-trial followed by an open-label cohort-controlled extension

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000326-19-NO

Enrollment

140

Registered

2016-04-11

Start date

2016-12-02

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Interventions

Trade Name: Botox Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Botox CAS Number: 93384-43-1 Other descriptive name: BOTULINUM TOXIN TYPE A Concentration unit: IU/ml inte

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: adolesent (12-18 years), BMI or ISO-BMI > 35, not having achieved a clinically important, sustainable weight loss in a comprehensive multi-disciplinary lifestyle programme for obesity Are the trial subjects under 18? yes Number of subjects for this age range: 120 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Known hypersensitivity to excipients in IMP, neuromuscular disorders, history of disphagia, history of aspiration tendency or aspiration pneumonia, known lung disease under continuous treatment, congenital of acquired heart disease, previous experience of side effects for injections of BTA, present gastric diseases of dysfunction, previous experience of side effects for BTxA, previous bariatric surgery, history of cancer, serious binge eating disorder, untreated hyperthyroidism, use of aminoglycoside antibiotics or spectinomycin last week, use of any other medicinal products that interfere with neuromuscular transmission (neuromuscular blocking agents), medication known to affect appetite, syndromal obesity, mentally immature to the degree that there is doubt about the subject's ability to consent, issues related to language and culture that may complicate trial participation, pregnant or lactating women.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1.The study aims to detect a difference in proportions of treatment responders between the Botox group and placebo group of at least 25%. 2.Safety. ;Secondary Objective: Secondary: 1.Biological and psychological markers 2.Economic evaluation 3.Patients’ views and experiences ;Primary end point(s): Body weight (ISO-BMI);Timepoint(s) of evaluation of this end point: Baseline, 12 months, 24 months	—

Measure

Time frame

Main Objective: 1.The study aims to detect a difference in proportions of treatment responders between the Botox group and placebo group of at least 25%. 2.Safety. ;Secondary Objective: Secondary: 1.Biological and psychological markers 2.Economic evaluation 3.Patients’ views and experiences ;Primary end point(s): Body weight (ISO-BMI);Timepoint(s) of evaluation of this end point: Baseline, 12 months, 24 months

—

Secondary

Measure	Time frame
Secondary end point(s): Laboratory: Hb, HbA1c, glucose, C-peptide, Na, K, creatinine, HDL, LDL, total cholesterol, triglycerids, HS-CRP, ALAT. Clinical tests: Blood pressure Anthropometry: Height, weight, BodPod (body composition);Timepoint(s) of evaluation of this end point: Baseline, 12 months, 24 months	—

Countries

Norway

Contacts

Public ContactDepartment of Surgery

St Olavs Hospital Trondheim University Hospital

+4748306262

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026