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

Phase 2

Completed

• Conditions: Obesity
• Interventions: Drug: LIK066; Dietary Supplement: Carbohydrate 50%; Dietary Supplement: Carbohydrate 8%; Dietary Supplement: Carbohydrate 25%; Dietary Supplement: Psyllium; Dietary Supplement: Carbohydrate 0%; Dietary Supplement: Calcium carbonate

• Registration Number: NCT03198767
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-16
• Study Start: 2017-06-21
• Study First Submitted QC: 2017-06-22
• Study First Posted: 2017-06-26
• Primary Completion: 2017-09-04
• Study Completion: 2017-09-04
• Results First Submitted: 2018-08-27
• Results First Submitted QC: 2018-08-27
• Results First Posted: 2018-09-25
• Status Verified: 2019-05
• Last Update Submitted: 2020-12-09
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO	Carbohydrate 0%	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
Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO	Carbohydrate 0%	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
Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO	LIK066	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
Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO	Carbohydrate 25%	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
Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO	Carbohydrate 25%	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
Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO	Carbohydrate 50%	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
Part A: LIK066 + P1: 8% CHO	Carbohydrate 8%	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.
Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO	LIK066	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
Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO	LIK066	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
Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO	Carbohydrate 25%	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
Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS	Psyllium	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)
Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO	Carbohydrate 50%	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
Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO	Carbohydrate 50%	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
Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO	Carbohydrate 0%	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
Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC	Psyllium	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)
Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS	Carbohydrate 50%	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)
Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS	LIK066	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)
Part A: LIK066 + P1: 8% CHO	LIK066	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.
Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC	LIK066	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)
Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC	Calcium carbonate	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)
Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS	LIK066	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)
Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS	Psyllium	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)
Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC	Carbohydrate 50%	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)
Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS	Calcium carbonate	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)
Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS	Calcium carbonate	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)
Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS	Carbohydrate 50%	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)

Primary Outcome Measures

Name	Time	Method
Number of Episodes of Diarrhea (Part A and Part B)	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 Outcome Measures

Name	Time	Method
Average Stool pH (Part A and Part B)	24 hours on Day 3 of each treatment period	Average PH of Stool at day 3
Average Consistency With Bristol Stool Chart (Part A and Part B)	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).
Three-day Total Number of Episodes of Diarrhea (Part A and Part B)	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.
Average Stool Weight (Part A and Part B)	24 hours on Day 3 of each treatment period	24 hour average stool weight on day 3

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 Lincoln, Nebraska, United States