Effect of Bile Acids on Satiety, Cell Function and Body Weight in Patients With Obesity and Abnormal Satiety Phenotype

NCT05314374 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 21-008310K23DK114460
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to study the effect of the study drug (a conjugated bile acid dietary supplement) or placebo on cell function, hormones and body weight.

Conditions

Obesity; Healthy

Keywords

BMI of 30 or greater

Outcome Measures

Primary Outcomes (2)

• Glucagon-Like Peptide-1 (GLP-1)

  The number of participants that provided a blood sample for GLP-1 (ug/ml) .

  90 days

• Peptide Trosin Tyrosine (PYY) Hormone

  The number of participants that provided a blood sample for PYY.

  90 days

Secondary Outcomes (1)

• Change in Weight

  Baseline, 12 weeks

Study Arms (2)

Bile Acid Supplement Group

EXPERIMENTAL

Subjects with obesity and abnormal satiety phenotype will receive ileocolonic-release conjugated bile acid supplements

Dietary Supplement: Ileocolonic-release conjugated bile acid

Placebo Group

PLACEBO COMPARATOR

Subjects with obesity and abnormal satiety phenotype will receive matching-placebo

Drug: Placebo

Interventions

Ileocolonic-release conjugated bile acid DIETARY_SUPPLEMENT

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.

Also known as: IC-CBAS

Bile Acid Supplement Group

Placebo DRUG

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.

Also known as: Matching-placebo

Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• I. Patients with obesity BMI\> 30 kg/m2 and hungry gut phenotype.
• II. Age: 18-65 years.
• III. Gender: men or women. Women of childbearing potential will have a negative pregnancy test before initiation of medication and within 48 hours of receiving radioisotope for the gastric emptying study.
• IV. Otherwise healthy individuals or with controlled chronic medical conditions such as type 2 diabetes.

You may not qualify if:

• I. Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders. For screening the bowel disease questionnaire will be used to exclude subjects with irritable bowel syndrome.
• II. Subjects with stool type Bristol classification 6-7 per bowel disease questionnaire.
• III. Female subjects who are pregnant or breast-feeding.
• IV. Use of anti-obesity medications upon screening (ie., orlistat, phentermine-topiramate, liraglutide, semaglutide, bupropion-naltrexone), metformin or GLP-1 analogs.
• V. Individuals who are currently on treatment for unstable cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine, and psychiatric disease.
• VI. Any acute or chronic condition or other disease that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study.
• VII. Significant untreated psychiatric dysfunction based upon screening. Hospital Anxiety and Depression Inventory (HAD) score \>11 on depression scale, a self-administered alcoholism screening test (AUDIT-C) score \>4 in men or \>3 in women, and difficulties with substance or eating disorders determined by the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia); will mean the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. The provider will review the patient's alcohol intake over the past few months to confirm accuracy and determine study eligibility.
• VII. Principal Investigator discretion.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Andres Acosta
• Organization: Mayo Clinic

acosta.andres@mayo.edu

507-266-6931

Study Officials

• Andres Acosta, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: April 6, 2022
• Study Start: May 12, 2023
• Primary Completion: March 22, 2024
• Study Completion: November 13, 2024
• Last Updated: May 4, 2025
• Results First Posted: May 4, 2025

Record last verified: 2025-04

Locations

US (1)