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Completed

NCT Number: NCT03198767

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

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.

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Key information

Conditions

Obesity Body Weight Diarrhea Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LIK066

Drug

LIK066 50 mg tablets. Open-label, bulk, blister-pack.

Carbohydrate 50%

Dietary Supplement

50% carbohydrate in breakfast meal

Carbohydrate 25%

Dietary Supplement

25% carbohydrate in breakfast meal

Carbohydrate 8%

Dietary Supplement

8% carbohydrate in breakfast meal

Carbohydrate 0%

Dietary Supplement

0% carbohydrate in breakfast meal

Psyllium

Dietary Supplement

Powder 6 grams

Other names: MetaMucil®

Calcium Carbonate

Dietary Supplement

Liquid 1 gram (4 mL equivalent sugar free)

Other names: Quality Value®

Primary outcomes

  1. Number of Episodes of Diarrhea (Part A and Part B)

    Time frame: 24 hours on Day 3 of each treatment period

    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.

Secondary outcomes

  1. Three-day Total Number of Episodes of Diarrhea (Part A and Part B)

    Time frame: Day 1 to 3 of each treatment period

    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.

  2. Average Consistency With Bristol Stool Chart (Part A and Part B)

    Time frame: 24 hours on Day 3 of each treatment period

    BSC is frequently used as a measure of consistency, ranging from score 1 (hard lumps) to 7 (watery stool).

  3. Average Stool pH (Part A and Part B)

    Time frame: 24 hours on Day 3 of each treatment period

    Average PH of Stool at day 3

  4. Average Stool Weight (Part A and Part B)

    Time frame: 24 hours on Day 3 of each treatment period

    24 hour average stool weight on day 3

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 26, 2017
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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