Treatment of morbid obesity through stomach injections of Botulinum toxin A: A pilot study

Treatment of morbid obesity through intra-gastric injections of Botulinum toxin A: A pilot study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004381-18-NO

Enrollment

Registered

2012-11-02

Start date

2013-06-04

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

Morbid obesity (obesity class 3)

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: Adult (18-60 years) volunteers with morbid obesity (BMI > 40 kgs/m2, or BMI > 35 kgs/m2 if obesity related comorbidity, accepted for bariatric surgery) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Previous side-effects from botox injections -Previous bariatric surgery -Previous cancer disease in the GI-tract -Other obesity treatment the last 3 mts (drug or lifestyle-based) -Severe binge-eating disorder -Hypothyroidism -Pregnancy -Inadequate capacity to consent

Design outcomes

Primary

Measure	Time frame
Main Objective: A proof-of-concept study of the effect of intragastric injection of Botulinum toxin A on weight loss in morbidly obese patients. The study will provide basis for calculating sample size for a future double-blinded randomized controlled trial. To do so we need experience with the degree and variability of weight loss;Secondary Objective: not applicable;Primary end point(s): body weight;Timepoint(s) of evaluation of this end point: at baseline, 4 weeks, 8 weeks	—

Measure

Time frame

Main Objective: A proof-of-concept study of the effect of intragastric injection of Botulinum toxin A on weight loss in morbidly obese patients. The study will provide basis for calculating sample size for a future double-blinded randomized controlled trial. To do so we need experience with the degree and variability of weight loss;Secondary Objective: not applicable;Primary end point(s): body weight;Timepoint(s) of evaluation of this end point: at baseline, 4 weeks, 8 weeks

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Secondary

Measure	Time frame
Secondary end point(s): Laboratory: -Hb, HbA1c, glucose, C-peptide, Na, K, creatinine, HDL, LDL, total-kolesterol, triglycerids, HS-CRP, ALAT Clinical tests: -Blood pressure , ECG Anthropometry: -Height, weight, BodPod (body composition) Questionnaires: -Symptoms (Gastrointestinal Symptom Rating Scale), Hunger/satiety, Food diary;Timepoint(s) of evaluation of this end point: at baseline, 4 weeks, 8 weeks	—

Measure

Time frame

Secondary end point(s): Laboratory: -Hb, HbA1c, glucose, C-peptide, Na, K, creatinine, HDL, LDL, total-kolesterol, triglycerids, HS-CRP, ALAT Clinical tests: -Blood pressure , ECG Anthropometry: -Height, weight, BodPod (body composition) Questionnaires: -Symptoms (Gastrointestinal Symptom Rating Scale), Hunger/satiety, Food diary;Timepoint(s) of evaluation of this end point: at baseline, 4 weeks, 8 weeks

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Countries

Norway

Contacts

Public ContactCenter for Obesity, Dept Surgery

St. Olavs Hospital Trondheim University Hospital

+4748306262

Outcome results

None listed

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