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ACARBOSE

Clinical trials are investigating ACARBOSE in people with obesity. This article explains what the study tested, who took part, and what outcomes were measured, such as tolerability during dose-escalation and symptom scores. The trial compared ACARBOSE-related treatment strategies with other obesity treatments.

Table of Contents

Trial overview

The provided data includes one clinical trial of ACARBOSE: 2024-520122-11-00, called “A PilOt dose-escalation trial with EMP16 in preparation for Phase III – the POEM trial.”[1]

This was a Phase 2 interventional study and it was marked as Completed.[1]

The trial studied people with obesity.[1]

Study design and treatment comparison

The brief summary says the study was designed to compare the combination of EMP16 plus Vi-Siblin® S with the combination of conventional orlistat plus placebo dietary fibre supplementation during dose-escalation.[1]

The interventions listed in the source include ACARBOSE, ORLISTAT, Vi-Siblin S granulat, alli 60 mg hard capsules, dietary fibre supplement, and a placebo made of maltodextrin.[1]

A placebo is a look-alike treatment used for comparison, and it does not contain the active study treatment.[1]

Who participated

The trial enrolled 39 participants.[1]

The source does not give more detail about age, sex, or other entry rules, so the available information only shows that the target population was people with obesity.[1]

What the trial measured

The primary outcome was the difference in total GITE1 score between EMP16 combined with Vi-Siblin® S and conventional orlistat combined with placebo dietary fibre supplement.[1]

This means the researchers were comparing how the two treatment approaches were tolerated during dose increases.[1]

Dose-escalation means the amount of treatment is increased step by step, so researchers can watch how people respond as the dose changes.[1]

What the trial results mean for patients

From the data provided, this ACARBOSE-related trial was not designed to prove long-term benefit in obesity, but to study tolerability in a controlled research setting.[1]

Because the study was completed, the planned testing phase has ended, but the source does not provide the final results or whether the treatment strategy moved forward to later studies.[1]

For patients, the key point is that ACARBOSE appears in a trial focused on obesity research, where the main question was how well the treatment plan could be used during dose increases.[1]

Trial ID Phase Condition studied Status Enrollment
2024-520122-11-00 Phase 2 Obesity Completed 39

FAQ

  • What clinical trial studied ACARBOSE in this data? One completed Phase 2 interventional trial studied ACARBOSE in people with obesity. It looked at treatment tolerability during dose-escalation and compared study combinations.
  • What condition was being studied with ACARBOSE? The trial focused on obesity. This means the study was designed for adults with excess body weight, although the source does not give more detail about the exact participant rules.
  • What was the main goal of the trial? The main goal was to compare tolerability during dose-escalation. In simple words, the researchers wanted to see how well the treatment plan was accepted as the dose was increased.
  • What phase was the ACARBOSE trial? The trial was Phase 2. Phase 2 studies usually explore whether a treatment is promising and how well it is tolerated in a specific patient group.
  • What outcome was measured in the trial? The primary outcome was the difference in total GITE1 score between two treatment combinations. This score was used to compare how the study treatments were tolerated.

Ongoing Clinical Trials on ACARBOSE

  • Study on the Effects of EMP16 and Ispaghula Husk for Obesity in Adults

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Sweden

Glossary

  • Obesity: A condition where a person has too much body fat, which can affect health.
  • Interventional study: A study where researchers give a treatment or compare treatments to see what happens.
  • Phase 2: A mid-stage clinical trial that looks at whether a treatment may work and how well it is tolerated.
  • Enrollment: The number of people who joined the study.
  • Completed: The study has finished and the planned data collection is done.
  • Dose-escalation: A step-by-step increase in the amount of treatment given, used to study tolerability.
  • Tolerability: How well people can take a treatment without major problems.
  • Primary outcome: The main result the researchers planned to measure.
  • GITE1 score: A study score used to compare tolerability between treatment groups.
  • Placebo: A look-alike treatment with no active study drug, used for comparison.

References

  1. https://clinicaltrials.gov/study/2024-520122-11-00