CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 54 enrolled
Drug / intervention
LIK066 +6 moredrug
Likely dose
LIK066 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03198767
NCT03198767Phase 2Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted Jun 26, 2017·Updated Jan 5, 2021

In Brief

A Phase 2 clinical trial evaluating LIK066, Carbohydrate 50%, and 5 other interventions for Obesity. Completed, enrolled 54 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 26, 2017
Enrollment StartJun 21, 2017
Primary CompletionSep 4, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.0 years ago

Interventions

LIK066drug

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

Carbohydrate 50%dietary

50% carbohydrate in breakfast meal

Carbohydrate 25%dietary

25% carbohydrate in breakfast meal

Carbohydrate 8%dietary

8% carbohydrate in breakfast meal

Carbohydrate 0%dietary

0% carbohydrate in breakfast meal

Psylliumdietary

Powder 6 grams

Calcium carbonatedietary

Liquid 1 gram (4 mL equivalent sugar free)