Phase 2 N=54 Randomized Basic Science

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

Obesity

Bottom Line

View on ClinicalTrials.gov: NCT03198767 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2018

Primary outcome: Primary: Number of Episodes of Diarrhea (Part A and Part B) — 1.67; 1.25; 0.38; 1.88 Number of stools — p=0.202

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: LIK066 (Drug); Carbohydrate 50% (Dietary_supplement); Carbohydrate 25% (Dietary_supplement); Carbohydrate 8% (Dietary_supplement); Carbohydrate 0% (Dietary_supplement); Psyllium (Dietary_supplement); Calcium carbonate (Dietary_supplement)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Sep 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Episodes of Diarrhea (Part A and Part B)	1.67; 1.25; 0.38; 1.88; 1.46; 1.46	0.202
SECONDARY Three-day Total Number of Episodes of Diarrhea (Part A and Part B)	3.96; 2.83; 1.50; 4.42; 3.46; 4.00	0.040 sig
SECONDARY Average Consistency With Bristol Stool Chart (Part A and Part B)	5.45; 5.42; 4.71; 5.81; 5.52; 5.62	0.426
SECONDARY Average Stool pH (Part A and Part B)	6.35; 6.50; 6.29; 6.52; 6.79; 6.66	—
SECONDARY Average Stool Weight (Part A and Part B)	136.5; 154.5; 116.7; 145.5; 177.1; 164.3	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03198767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.