Intra-gastric Fundal and Body Injection of Botulinum Toxin A for Weight Loss, a Randomized Controlled Trial

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04274608

Enrollment

Registered

2020-02-18

Start date

2020-01-01

Completion date

2022-07-31

Last updated

2020-02-18

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

Conditions

Obesity, Weight Loss

Brief summary

This is a randomized controlled trial to compare intra-gastric injection of Botulinum Toxin A (Botox; Allergan Inc. Irvine, Ca, USA) against non-surgical management for obesity (i.e. exercise/diet). Our hypothesis is that intra-gastric injection of Botox into the fundus and body of the stomach will result in greater weight loss than just exercise and diet alone.

Interventions

DRUGBotulinum toxin type A

Intragastric injection of Botulinum toxin type A

BEHAVIORALWeight Management Program

12 week weight management program

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Randomized Controlled Trial

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

1. Age 21 to 65yrs old 2. BMI \>32.5 (Class II obesity)

Exclusion criteria

1. Pregnancy or lactation 2. Known pre-existing neuromuscular disorders or peripheral motor neuropathic disease (e.g. amyotrophic lateral sclerosis, motor neuropathy) 3. Patients with known liver cirrhosis or known esophageal/gastric varices 4. Known eating disorders 5. Known major cardiovascular or pulmonary conditions 6. Previous gastric/bariatric surgery 7. Pathologic changes of the esophagus/stomach/duodenum demonstrated on endoscopy (esophagitis, peptic ulcers, cancer) 8. Known alcohol or drug abuse 9. Known allergy to any ingredients in Botox or allergic reaction to any other botulinum toxin product

Design outcomes

Primary

Measure	Time frame	Description
Weight loss	1 year	Examine the average weight loss
Time to weight regain following a single injection of intra-gastric Botox	1 year	—

Secondary

Measure	Time frame	Description
Gut hormone level	1 year	Ghrelin
Gut hormone level ( Leptin)	1 year	Leptin
Satiety index	1 year	—
Co-morbidities	1 year	Diabetes, hypertension, hyperlipidemia

Countries

Singapore

Contacts

Primary ContactDanson Yeo, MBBS, MRCS, FRCS

danson_xw_yeo@ttsh.com.sg+65 81834111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026