ObesityPhase 2/3NCT04274608
Intra-gastric Fundal and Body Injection of Botulinum Toxin A for Weight Loss, a Randomized Controlled Trial
A Phase 2/3 study testing Botulinum toxin type A and Weight Management Program in people with Obesity and Weight Loss, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- Botulinum toxin type A and Weight Management Program
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jan 2020to Jul 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 21 to 65yrs old
- BMI >32.5 (Class II obesity)
Who cannot join
- Pregnancy or lactation
- Known pre-existing neuromuscular disorders or peripheral motor neuropathic disease (e.g. amyotrophic lateral sclerosis, motor neuropathy)
- Patients with known liver cirrhosis or known esophageal/gastric varices
- Known eating disorders
- Known major cardiovascular or pulmonary conditions
- Previous gastric/bariatric surgery
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- Pathologic changes of the esophagus/stomach/duodenum demonstrated on endoscopy (esophagitis, peptic ulcers, cancer)
- Known alcohol or drug abuse
- Known allergy to any ingredients in Botox or allergic reaction to any other botulinum toxin product
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Tan Tock Seng Hospital
Singapore, 308433
Danson Yeo, MBBS, +65 81834111, danson_xw_yeo@ttsh.com.sg
About this study
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.
- Conditions
- Obesity, Weight Loss
- Being tested
- Botulinum toxin type A, Weight Management Program
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intragastric injection of Botulinum toxin type A
Weight Management ProgramBehavioural
12 week weight management program
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Patients in the intervention arm will receive 300units of Botulinum Toxin A (Botox; Allergan Inc., Irvine, Ca, USA) diluted to 10mls of saline. Endoscopy will be performed using a single-lumen gastroscope. Injection of the solution will be done using a 23Gauge Interject needle catheter. 20 separate injections of 0.5ml each will be performed in a concentric ring 1cm apart. 10 injections will be performed into the body of the stomach, and 10 injections into the fundus, from the level of the CEJ and above
Patients will undergo a 12-week weight management program approximately 2 weeks after the injection of Botox. Receives: Drug: Botulinum toxin type A; Behavioral: Weight Management Program |
| Control Arm | Active comparator | Patients will undergo a 12-week weight management program. Receives: Behavioral: Weight Management Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Examine the average weight loss
Measured: 1 year
Time to weight regain following a single injection of intra-gastric Botox
Measured: 1 year
Secondary outcomes (4)
Gut hormone level
Ghrelin
Measured: 1 year
Gut hormone level ( Leptin)
Leptin
Measured: 1 year
Satiety index
Measured: 1 year
Co-morbidities
Diabetes, hypertension, hyperlipidemia
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start1 Jan 2020
- Primary completionJul 2021 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danson Yeo Xue Wei, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274608
- Sponsor's protocol ID
- TanTockSengH
- Status last verified
- Feb 2020
- First submitted
- 16 Feb 2020
- Last updated
- 18 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-gastric Fundal and Body Injection of Botulinum Toxin A for Weight Loss, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04274608
- Acronym / sponsor ID
- TanTockSengH
- Conditions
- Obesity, Weight Loss
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Drug: Botulinum toxin type A, Behavioral: Weight Management ProgramPatients in the intervention arm will receive 300units of Botulinum Toxin A (Botox; Allergan Inc., Irvine, Ca, USA) diluted to 10mls of saline. Endoscopy will be performed using a single-lumen gastroscope. Injection of the solution will be done using a 23Gauge Interject needle catheter. 20 separate injections of 0.5ml each will be performed in a concentric ring 1cm apart. 10 injections will be performed into the body of the stomach, and 10 injections into the fundus, from the level of the CEJ and above Patients will undergo a 12-week weight management program approximately 2 weeks after the injection of Botox. |
| Control Arm | Active comparator | Behavioral: Weight Management ProgramPatients will undergo a 12-week weight management program. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 21 to 65yrs old
- BMI >32.5 (Class II obesity)
Key exclusion criteria (9 listed)
- Pregnancy or lactation
- Known pre-existing neuromuscular disorders or peripheral motor neuropathic disease (e.g. amyotrophic lateral sclerosis, motor neuropathy)
- Patients with known liver cirrhosis or known esophageal/gastric varices
- Known eating disorders
- Known major cardiovascular or pulmonary conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type AIntragastric injection of Botulinum toxin type A | Drug | Intervention Arm |
| Weight Management Program12 week weight management program | Behavioural | Control Arm, Intervention Arm |
Primary outcome
Weight loss
Time frame: 1 year
Examine the average weight loss
Time to weight regain following a single injection of intra-gastric Botox
Time frame: 1 year
4 secondary outcomes
Gut hormone level
Time frame: 1 year
Gut hormone level ( Leptin)
Time frame: 1 year
Satiety index
Time frame: 1 year
Co-morbidities
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Botulinum toxin type A and Weight Management Program in people with Obesity and Weight Loss, run by Tan Tock Seng Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danson Yeo, MBBS, MRCS, FRCS (+65 81834111, danson_xw_yeo@ttsh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020; AzTrials last refreshed its copy on 8 Nov 2026.