Trial · NCT05130047

Aldafermin (NGM282) for Chronic Diarrhea Due to Bile Acid Malabsorption (BAM)

NCT05130047, Phase 2, Completed, Michael Camilleri, MD; results first posted 2023-10-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Aldafermin (NGM282) for Chronic Diarrhea Due to Bile Acid Malabsorption (BAM). Trials, record NCT05130047. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05130047

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Aldafermin (NGM282) for Chronic Diarrhea Due to Bile Acid Malabsorption (BAM)
NCT number: NCT05130047
Status: Completed
Phases: Phase 2
Enrollment: 30 participants, actual
Lead sponsor: Michael Camilleri, MD
Conditions: Chronic Diarrhea, Irritable Bowel Syndrome With Diarrhea, Bile Acid Malabsorption, Bile Acid Diarrhea, Bile Acid Malabsorption Syndrome Type II, Functional Diarrhea
Interventions: Aldafermin, Placebo
First posted: 2021-11-22
Last updated: 2023-10-12
Results first posted: 2023-10-12

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Fasting Serum C4 Levels	28 days	Fasting serum C4 is measured by liquid chromatography-mass spectrometry.
Primary	Change in Stool Consistency From Baseline to Day 28	Baseline, 28 days	Stool consistency as reported by the patient in daily bowel pattern diaries. Stool consistency is based on Bristol Stool Form Scale (BSFS) 1: Hard lumps; 2:Lumpy sausage; 3: Cracked sausage; 4: Smooth sausage; 5: Soft lumps; 6: Mushy; 7: Watery. spectrometry.
Secondary	Stool Consistency	14 days, 28 days	Stool consistency as reported by the patient in daily bowel pattern diaries. Stool consistency is based on Bristol Stool Form Scale (BSFS) 1: Hard lumps; 2:Lumpy sausage; 3: Cracked sausage; 4: Smooth sausage; 5: Soft lumps; 6: Mushy; 7: Watery.
Secondary	Abdominal Pain Score	baseline, 28 days	Abdominal pain rated by patient using an 11-point scale, 0 to 10 inclusive with 0 as none and 10 as worst imaginable abdominal pain.
Secondary	Bowel Movements	baseline, 28 days	The total number of bowel movements per day reported by the participant in the daily bowel pattern diary.
Secondary	Proportion of Fecal Secretory (CDCA + DCA) Bile Acid as Measured in a Random Stool Sample by a Validated Laboratory Assay.	Baseline, 14 days, 28 days	Fecal secretory bile acids are expressed as a percentage of the total bile acids as measured by high performance liquid chromatography-mass spectrometry.
Secondary	Proportion of Fecal Primary (CDCA + CA) Bile Acid as Measured in a Random Stool Sample by a Validated Laboratory Assay.	Baseline,14 days, 28 days	Fecal primary bile acids are expressed as a percentage of the total bile acids as measured by high performance liquid chromatography-mass spectrometry.
Secondary	Total Fecal Bile Acid Concentration in a Random Stool Sample as Measured by a Validated Laboratory Assay.	baseline,14 days, 28 days	Total fecal bile acids concentration in micromoles of bile acid per gram stool as measured by high performance liquid chromatography-mass spectrometry.
Secondary	Total Aldafermin Concentration in Serum as Measured by a Validated Laboratory Assay	baseline, 14 days, 28 days	Validated aldafermin concentration (PK) laboratory assay

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Fasting Serum C4 Levels	28 days		ng/ML	MEDIAN
PRIMARY	Change in Stool Consistency From Baseline to Day 28	Baseline, 28 days		score on a scale	MEDIAN
SECONDARY	Stool Consistency	14 days, 28 days		score on a scale	MEDIAN
SECONDARY	Abdominal Pain Score	baseline, 28 days		score on a scale	MEDIAN
SECONDARY	Bowel Movements	baseline, 28 days		bowel movements per day	MEDIAN
SECONDARY	Proportion of Fecal Secretory (CDCA + DCA) Bile Acid as Measured in a Random Stool Sample by a Validated Laboratory Assay.	Baseline, 14 days, 28 days		percentage of the total bile acids	MEDIAN
SECONDARY	Proportion of Fecal Primary (CDCA + CA) Bile Acid as Measured in a Random Stool Sample by a Validated Laboratory Assay.	Baseline,14 days, 28 days		percentage of the total bile acids	MEDIAN
SECONDARY	Total Fecal Bile Acid Concentration in a Random Stool Sample as Measured by a Validated Laboratory Assay.	baseline,14 days, 28 days		mmol/g	MEDIAN
SECONDARY	Total Aldafermin Concentration in Serum as Measured by a Validated Laboratory Assay	baseline, 14 days, 28 days	Data was not collected nor analyzed

Source ClinicalTrials.gov

Results by group34

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Fasting Serum C4 Levels	Aldafermin (NGM282)		2.2	Inter-Quartile Range 1.6 to 3.3	ng/ML
Fasting Serum C4 Levels	Placebo		50.4	Inter-Quartile Range 25.8 to 106.0	ng/ML
Change in Stool Consistency From Baseline to Day 28	Aldafermin (NGM282)		-0.4	Inter-Quartile Range -1.2 to 0.1	score on a scale
Change in Stool Consistency From Baseline to Day 28	Placebo		-0.02	Inter-Quartile Range -0.4 to 0.3	score on a scale
Stool Consistency	Aldafermin (NGM282)	Day 14	4.6	Inter-Quartile Range 4.3 to 5.0	score on a scale
Stool Consistency	Placebo	Day 14	4.8	Inter-Quartile Range 4.0 to 5.3	score on a scale
Stool Consistency	Aldafermin (NGM282)	Day 28	4.4	Inter-Quartile Range 4.2 to 5.0	score on a scale
Stool Consistency	Placebo	Day 28	5.1	Inter-Quartile Range 4.4 to 5.5	score on a scale
Abdominal Pain Score	Aldafermin (NGM282)	Baseline	0.9	Inter-Quartile Range 0.0 to 3.6	score on a scale
Abdominal Pain Score	Placebo	Baseline	0.4	Inter-Quartile Range 0 to 1.0	score on a scale

1 to 10 of 34Source ClinicalTrials.gov

See all 34 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Aldafermin (NGM282)	15
Overall Study	STARTED	Placebo	15
Overall Study	COMPLETED	Aldafermin (NGM282)	15
Overall Study	COMPLETED	Placebo	15
Overall Study	NOT COMPLETED	Aldafermin (NGM282)	0
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events22

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Increased diarrhea	Gastrointestinal disorders	Aldafermin (NGM282)	2	15
other	Increased diarrhea	Gastrointestinal disorders	Placebo	1	15
other	Abdominal pain	Gastrointestinal disorders	Aldafermin (NGM282)	1	15
other	Abdominal pain	Gastrointestinal disorders	Placebo	2	15
other	Other gastrointestinal symptoms	Gastrointestinal disorders	Aldafermin (NGM282)	3	15
other	Other gastrointestinal symptoms	Gastrointestinal disorders	Placebo	3	15
other	Increased LDL Cholesterol	Investigations	Aldafermin (NGM282)	4	15
other	Increased LDL Cholesterol	Investigations	Placebo	0	15
other	Irritation at injection site	Skin and subcutaneous tissue disorders	Aldafermin (NGM282)	3	15
other	Irritation at injection site	Skin and subcutaneous tissue disorders	Placebo	1	15

1 to 10 of 22Source ClinicalTrials.gov

See all 22 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Aldafermin (NGM282)	0	15
Total, all-cause mortality	Placebo	0	15
Total, other adverse events	Aldafermin (NGM282)	14	15
Total, other adverse events	Placebo	7	15
Total, serious adverse events	Aldafermin (NGM282)	1	15
Total, serious adverse events	Placebo	0	15

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Aldafermin (NGM282) vs Placebo: deaths from any cause	Trial comparisons
Aldafermin (NGM282) vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05130047

GET https://conductscience.org/api/trials/v1/NCT05130047/results?page=2

API reference For AI assistants