Study Summary
This trial is testing if aldafermin can help improve bowel function and bile acid excretion in patients with diarrhea caused by bile acid malabsorption.
- Bile Acid Diarrhea
- Bile Acid Malabsorption Syndrome Type II
- Functional Diarrhea
- Chronic Functional Diarrhea
- Diarrhoea Predominant Irritable Bowel Syndrome (IBS-D)
- Bile Acid Malabsorption
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
4 Primary · 12 Secondary · Reporting Duration: 14 days, 28 days
Trial Safety
Phase-Based Safety
Trial Design
2 Treatment Groups
Aldafermin (NGM282)
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
35 Total Participants · 2 Treatment Groups
Primary Treatment: Aldafermin · Has Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 75 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
How old are they?
| 18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
Frequently Asked Questions
Has Aldafermin achieved official authorization from the FDA?
"Taking into account the Phase 2 status of this drug, our team at Power assigned Aldafermin a safety rating of two since there is some data confirming its security but no clinical evidence to support efficacy." - Anonymous Online Contributor
What goals are researchers aiming to achieve from this research?
"According to the trial sponsor, NGM Biopharmaceuticals, Inc., primary outcomes are Change in fasting serum C4 levels from baseline as measured by a validated laboratory assay and will be quantified over 28 days. Additionally, secondary metrics such as Average daily stool consistency score (which is based on Bristol Stool Form Scale), Maximum abdominal pain score, and Number of bowel movements per week will also be evaluated." - Anonymous Online Contributor
Are the criteria for this experiment open to my participation?
"This medical research is recruiting 30 individuals, aged 18 to 75 years old and suffering from functional diarrhea or IBS with diarrhoea based on Rome III or IV criteria. Other requirements include C4 serum levels above 52 ng/mL, fecal BA of more than 2,337 μmoles / 48 hours, total fecal BA greater than 1,000 μmoles / 48 hours plus 4% primary BA, body mass index between 18.0-45.0 kg/m2 as well as an understanding and willingness to comply with the study's procedures; tricyclic antidepressants (TCAs), selective serotonin reuptake" - Anonymous Online Contributor
Is there presently any opportunity to join this trial?
"Indeed, clinicaltrials.gov records confirm that recruitment for this medical experiment is ongoing and has been since December 1st 2021. The most recent update to the trial was made on April 20th 2022; 30 participants are needed at a single site." - Anonymous Online Contributor
Is this experiment open to participants aged 18 or above?
"This study is open to those over 18 years old but under 75, providing they meet the necessary criteria." - Anonymous Online Contributor
How many individuals are the maximum allowed to take part in this trial?
"Affirmative. Clinicaltrials.gov data indicates that this ongoing research is currently accepting volunteers; it was uploaded on December 1st 2021 and last updated April 20th 2022, with a requirement for 30 participants from one centre." - Anonymous Online Contributor
Can you discuss any other experiments conducted with Aldafermin?
"Currently, there are two active Aldafermin trials with none in the third phase. Rochester is a central location for these studies but 72 other sites are also conducting experiments related to this drug." - Anonymous Online Contributor
Does this trial represent a pioneering medical initiative?
"Since 2020, Aldafermin has been the subject of multiple clinical trials. NGM Biopharmaceuticals, Inc was responsible for initiating its research in that year with an initial cohort size of 160 participants. After successful Phase 2 results were obtained, two active studies are currently being conducted across 10 nations and 46 cities." - Anonymous Online Contributor