Trial Outcomes & Findings for Effect of Bile Acids on Satiety, Cell Function and Body Weight in Patients With Obesity and Abnormal Satiety Phenotype (NCT NCT05314374)
NCT ID: NCT05314374
Last Updated: 2025-05-04
Results Overview
The number of participants that provided a blood sample for GLP-1 (ug/ml) .
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
35 participants
Primary outcome timeframe
90 days
Results posted on
2025-05-04
Participant Flow
Participant milestones
| Measure |
Bile Acid Supplement Group
Subjects with obesity and abnormal satiety phenotype will receive ileocolonic-release conjugated bile acid supplements
Ileocolonic-release conjugated bile acid: 1000mg tablets orally twice a daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 4 days
|
Placebo Group
Subjects with obesity and abnormal satiety phenotype will receive matching-placebo
Placebo: Placebo looks exactly like the study drug, but it contains no active ingredient. 1000mg tablets orally twice a daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 4 days.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
17
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Bile Acid Supplement Group
Subjects with obesity and abnormal satiety phenotype will receive ileocolonic-release conjugated bile acid supplements
Ileocolonic-release conjugated bile acid: 1000mg tablets orally twice a daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 4 days
|
Placebo Group
Subjects with obesity and abnormal satiety phenotype will receive matching-placebo
Placebo: Placebo looks exactly like the study drug, but it contains no active ingredient. 1000mg tablets orally twice a daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 4 days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
Baseline Characteristics
Effect of Bile Acids on Satiety, Cell Function and Body Weight in Patients With Obesity and Abnormal Satiety Phenotype
Baseline characteristics by cohort
| Measure |
Bile Acid Supplement Group
n=18 Participants
Subjects with obesity and abnormal satiety phenotype will receive ileocolonic-release conjugated bile acid supplements
Ileocolonic-release conjugated bile acid: 500 mg tablets orally twice daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 5 days. Subjects will receive 500 mg twice daily during their first week and 1000 mg twice daily for the rest of the study.
|
Placebo Group
n=17 Participants
Subjects with obesity and abnormal satiety phenotype will receive matching-placebo
Placebo: Placebo looks exactly like the study drug, but it contains no active ingredient. 500 mg tablets orally twice daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 5 days. Subjects will receive 500 mg twice daily during their first week and 1000 mg twice daily for the rest of the study.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
48.2 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
49.4 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
48.8 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Weight, kg
|
106.7 kg
STANDARD_DEVIATION 18.5 • n=5 Participants
|
108.1 kg
STANDARD_DEVIATION 24.3 • n=7 Participants
|
107 kg
STANDARD_DEVIATION 22 • n=5 Participants
|
|
Height, m
|
1.7 m
STANDARD_DEVIATION 0.1 • n=5 Participants
|
1.7 m
STANDARD_DEVIATION 0.1 • n=7 Participants
|
1.7 m
STANDARD_DEVIATION 0.1 • n=5 Participants
|
|
BMI (kg/m2)
|
35.3 kg/m2
STANDARD_DEVIATION 4 • n=5 Participants
|
37.9 kg/m2
STANDARD_DEVIATION 5.3 • n=7 Participants
|
36 kg/m2
STANDARD_DEVIATION 4.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 90 daysThe number of participants that provided a blood sample for GLP-1 (ug/ml) .
Outcome measures
| Measure |
Bile Acid Supplement Group
n=18 Participants
Subjects with obesity and abnormal satiety phenotype will receive ileocolonic-release conjugated bile acid supplements
Ileocolonic-release conjugated bile acid: 500 mg tablets orally twice daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 5 days. Subjects will receive 500 mg twice daily during their first week and 1000 mg twice daily for the rest of the study.
|
Placebo Group
n=17 Participants
Subjects with obesity and abnormal satiety phenotype will receive matching-placebo
Placebo: Placebo looks exactly like the study drug, but it contains no active ingredient. 500 mg tablets orally twice daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 5 days. Subjects will receive 500 mg twice daily during their first week and 1000 mg twice daily for the rest of the study.
|
|---|---|---|
|
Glucagon-Like Peptide-1 (GLP-1)
|
18 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: 90 daysThe number of participants that provided a blood sample for PYY.
Outcome measures
| Measure |
Bile Acid Supplement Group
n=18 Participants
Subjects with obesity and abnormal satiety phenotype will receive ileocolonic-release conjugated bile acid supplements
Ileocolonic-release conjugated bile acid: 500 mg tablets orally twice daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 5 days. Subjects will receive 500 mg twice daily during their first week and 1000 mg twice daily for the rest of the study.
|
Placebo Group
n=17 Participants
Subjects with obesity and abnormal satiety phenotype will receive matching-placebo
Placebo: Placebo looks exactly like the study drug, but it contains no active ingredient. 500 mg tablets orally twice daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 5 days. Subjects will receive 500 mg twice daily during their first week and 1000 mg twice daily for the rest of the study.
|
|---|---|---|
|
Peptide Trosin Tyrosine (PYY) Hormone
|
18 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksChange in weight, measured in kilograms (kg), from baseline visit to 12 weeks.
Outcome measures
| Measure |
Bile Acid Supplement Group
n=18 Participants
Subjects with obesity and abnormal satiety phenotype will receive ileocolonic-release conjugated bile acid supplements
Ileocolonic-release conjugated bile acid: 500 mg tablets orally twice daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 5 days. Subjects will receive 500 mg twice daily during their first week and 1000 mg twice daily for the rest of the study.
|
Placebo Group
n=17 Participants
Subjects with obesity and abnormal satiety phenotype will receive matching-placebo
Placebo: Placebo looks exactly like the study drug, but it contains no active ingredient. 500 mg tablets orally twice daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 5 days. Subjects will receive 500 mg twice daily during their first week and 1000 mg twice daily for the rest of the study.
|
|---|---|---|
|
Change in Weight
|
-0.82 kg
Interval -3.58 to 1.95
|
0.12 kg
Interval -1.86 to 2.1
|
Adverse Events
Bile Acid Supplement Group
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bile Acid Supplement Group
n=18 participants at risk
Subjects with obesity and abnormal satiety phenotype will receive ileocolonic-release conjugated bile acid supplements
Ileocolonic-release conjugated bile acid: 500 mg tablets orally twice daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 5 days. Subjects will receive 500 mg twice daily during their first week and 1000 mg twice daily for the rest of the study.
|
Placebo Group
n=17 participants at risk
Subjects with obesity and abnormal satiety phenotype will receive matching-placebo
Placebo: Placebo looks exactly like the study drug, but it contains no active ingredient. 500 mg tablets orally twice daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 5 days. Subjects will receive 500 mg twice daily during their first week and 1000 mg twice daily for the rest of the study.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
77.8%
14/18 • Adverse events were collected from the time of consent through completion of the study, approximately 12 weeks.
|
17.6%
3/17 • Adverse events were collected from the time of consent through completion of the study, approximately 12 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place