Effects of Carbohydrate in Diet and Supplements on the Gastrointestinal Tolerability of LIK066

A Randomized, Open Label, Two-part, Three-period, Cross Over Study to Investigate the Effects of Carbohydrate in Diet and to Evaluate Supplements on the Gastrointestinal Tolerability of LIK066 in Overweight or Obese Subjects

The purpose of this study was to determine if LIK066 taken with a meal containing low carbohydrate is associated with less diarrhea compared to a high carbohydrate meal and to assess the potential effects of supplements such as psyllium or calcium carbonate on alleviating diarrhea associated with LIK066.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: LIK066; Dietary supplement: Carbohydrate 50%; Dietary supplement: Carbohydrate 25%; Dietary supplement: Carbohydrate 0%; Dietary supplement: Carbohydrate 8%; Dietary supplement: Psyllium; Dietary supplement: Calcium carbonate

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• obese and overweight, BMI 25-50, HbA1C <10%

Exclusion Criteria:

• Preexisting, clinically significant cardiovascular, liver, renal, or GI disease that is considered unstable; pregnancy, Type 1 diabetes; Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO; Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 50% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 25% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 0% carbohydrate	Drug: LIK066; LIK066 50 mg tablets. Open-label, bulk, blister-pack.; Dietary supplement: Carbohydrate 50%; 50% carbohydrate in breakfast meal; Dietary supplement: Carbohydrate 25%; 25% carbohydrate in breakfast meal; Dietary supplement: Carbohydrate 0%; 0% carbohydrate in breakfast meal
EXPERIMENTAL: Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO; Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 25% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 0% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 50% carbohydrate	Drug: LIK066; LIK066 50 mg tablets. Open-label, bulk, blister-pack.; Dietary supplement: Carbohydrate 50%; 50% carbohydrate in breakfast meal; Dietary supplement: Carbohydrate 25%; 25% carbohydrate in breakfast meal; Dietary supplement: Carbohydrate 0%; 0% carbohydrate in breakfast meal
EXPERIMENTAL: Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO; Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 0% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 50% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 25% carbohydrate	Drug: LIK066; LIK066 50 mg tablets. Open-label, bulk, blister-pack.; Dietary supplement: Carbohydrate 50%; 50% carbohydrate in breakfast meal; Dietary supplement: Carbohydrate 25%; 25% carbohydrate in breakfast meal; Dietary supplement: Carbohydrate 0%; 0% carbohydrate in breakfast meal
EXPERIMENTAL: Part A: LIK066 + P1: 8% CHO; Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 8% carbohydrate (CHO) PROTOCOL DEVIATION: subjects received 8% CHO in error and were discontinued after Period 1.	Drug: LIK066; LIK066 50 mg tablets. Open-label, bulk, blister-pack.; Dietary supplement: Carbohydrate 8%; 8% carbohydrate in breakfast meal
EXPERIMENTAL: Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC; Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)	Drug: LIK066; LIK066 50 mg tablets. Open-label, bulk, blister-pack.; Dietary supplement: Carbohydrate 50%; 50% carbohydrate in breakfast meal; Dietary supplement: Psyllium; Powder 6 grams; Other Names: MetaMucil®; Dietary supplement: Calcium carbonate; Liquid 1 gram (4 mL equivalent sugar free); Other Names: Quality Value®
EXPERIMENTAL: Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS; Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)	Drug: LIK066; LIK066 50 mg tablets. Open-label, bulk, blister-pack.; Dietary supplement: Carbohydrate 50%; 50% carbohydrate in breakfast meal; Dietary supplement: Psyllium; Powder 6 grams; Other Names: MetaMucil®; Dietary supplement: Calcium carbonate; Liquid 1 gram (4 mL equivalent sugar free); Other Names: Quality Value®
EXPERIMENTAL: Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS; Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)	Drug: LIK066; LIK066 50 mg tablets. Open-label, bulk, blister-pack.; Dietary supplement: Carbohydrate 50%; 50% carbohydrate in breakfast meal; Dietary supplement: Psyllium; Powder 6 grams; Other Names: MetaMucil®; Dietary supplement: Calcium carbonate; Liquid 1 gram (4 mL equivalent sugar free); Other Names: Quality Value®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Episodes of Diarrhea (Part A and Part B)	Episodes of diarrhea is defined as the total number of stools with a Bristol Stool Chart (BSC) Score of 6 or 7 on day 3 of each treatment period. BSC is frequently used as a measure of consistency, and a score of 6 or 7 (pourable or watery stool) is considered abnormal.	24 hours on Day 3 of each treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Three-day Total Number of Episodes of Diarrhea (Part A and Part B)	Episodes of diarrhea is defined as the total number of stools with a Bristol Stool Chart (BSC) Score of 6 or 7 on days 1 to 3 of each treatment period. BSC is frequently used as a measure of consistency, and a score of 6 or 7 (pourable or watery stool) is considered abnormal.	Day 1 to 3 of each treatment period
Average Consistency With Bristol Stool Chart (Part A and Part B)	BSC is frequently used as a measure of consistency, ranging from score 1 (hard lumps) to 7 (watery stool).	24 hours on Day 3 of each treatment period
Average Stool pH (Part A and Part B)	Average PH of Stool at day 3	24 hours on Day 3 of each treatment period
Average Stool Weight (Part A and Part B)	24 hour average stool weight on day 3	24 hours on Day 3 of each treatment period

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• A Plain Language Trial Summary is available on novartisclinicatrials.com

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 21, 2017
• Primary Completion (ACTUAL): September 4, 2017
• Study Completion (ACTUAL): September 4, 2017

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: June 22, 2017
• First Posted (ACTUAL): June 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: body mass index; obesity; overweight; diarrhea; BMI
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Calcium-Regulating Hormones and Agents; Sodium-Glucose Transporter 2 Inhibitors; Cathartics; Antacids; Calcium; Calcium Carbonate; Licogliflozin; Psyllium
• Other Study ID Numbers: CLIK066B2203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No