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NCT00976443 · ClinicalTrials.gov registry record · Phase 1

Effects of Gastric Antral Botulinum Toxin Injections in Obese Subjects

A Phase 1 study, sponsored by Mayo Clinic.

Completed
Registry status
Phase 1
Development phase
60
Enrollment target

NCT00976443: Completed Phase 1 study, sponsored by Mayo Clinic.

NCT00976443 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00976443, a Phase 1 study, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
Phase 1
Development phase
60 participants
Enrollment target

Study Summary

Obesity is an important public health problem in the United States. The investigators hypothesize that stomach injections of botulinum toxin A (BTA), delivered through an endoscope using endoscopic ultrasound (EUS), may cause delayed gastric emptying, satiation, and reduction in body weight. This protocol is designed to study the effects and safety of gastric BTA injections. Subjects are randomized to receive placebo or one of two different doses of BTA injected into the stomach during one endoscopy, performed via the mouth. Gastric emptying, satiation, symptoms, psychological dimensions of eating behavior, and caloric intake are recorded before and after injections, and subjects are seen in follow-up for 24 weeks.

Interventions

  • DRUG BTA
  • DRUG Placebo (normal saline)

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2009-09
Est. Completion 2011-09
Phase Phase 1
Mayo Clinic

2,844 total trials

What the finished NCT00976443 record still lists

NCT00976443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which BTA is the first listed.

NCT00976443 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00976443 about?

NCT00976443 is a clinical study titled "Effects of Gastric Antral Botulinum Toxin Injections in Obese Subjects". Obesity is an important public health problem in the United States. The investigators hypothesize that stomach injections of botulinum toxin A (BTA), delivered through an endoscope using endoscopic ultrasound (EUS), may cause delayed gastric emptying, satiation, and reduction in body weight. This pr...

What is the current status of trial NCT00976443?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2009-09. Estimated completion is 2011-09.

What interventions are being tested in trial NCT00976443?

The interventions under investigation include: BTA (DRUG), Placebo (normal saline) (DRUG).

Who is sponsoring clinical trial NCT00976443?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00976443's enrollment target sits among peer trials

60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00976443, the US trial registry maintained by the National Library of Medicine. NCT00976443 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.