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ObesityPhase 2NCT03198767

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

A Phase 2 study testing LIK066, Carbohydrate 50% and Carbohydrate 25% in people with Obesity, run by Novartis Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
LIK066, Carbohydrate 50% and Carbohydrate 25%
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited States
Study dates
21 Jun 2017to 4 Sep 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Novartis Investigative Site

    Lincoln, Nebraska, 68502

Other trials in United States

About this study

Official 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

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.

Conditions
Obesity
Being tested
LIK066, Carbohydrate 50%, Carbohydrate 25%, Carbohydrate 8%, Carbohydrate 0%
Keywords
obesity, overweight, body mass index, BMI, diarrhea
Medical subject headings
Obesity, Overweight, Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LIK066Drug

    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

  • PsylliumDietary supplement

    Also called MetaMucil®

    Powder 6 grams

  • Calcium carbonateDietary supplement

    Also called Quality Value®

    Liquid 1 gram (4 mL equivalent sugar free)

Study groups in NCT03198767
Study groupRoleWhat they receive
Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHOExperimentalPeriod 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
Receives: Drug: LIK066; Dietary Supplement: Carbohydrate 50%; Dietary Supplement: Carbohydrate 25%; Dietary Supplement: Carbohydrate 0%
Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHOExperimentalPeriod 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
Receives: Drug: LIK066; Dietary Supplement: Carbohydrate 50%; Dietary Supplement: Carbohydrate 25%; Dietary Supplement: Carbohydrate 0%
Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHOExperimentalPeriod 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
Receives: Drug: LIK066; Dietary Supplement: Carbohydrate 50%; Dietary Supplement: Carbohydrate 25%; Dietary Supplement: Carbohydrate 0%
Part A: LIK066 + P1: 8% CHOExperimentalPeriod 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.
Receives: Drug: LIK066; Dietary Supplement: Carbohydrate 8%
Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CCExperimentalPeriod 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)
Receives: Drug: LIK066; Dietary Supplement: Carbohydrate 50%; Dietary Supplement: Psyllium; Dietary Supplement: Calcium carbonate
Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NSExperimentalPeriod 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)
Receives: Drug: LIK066; Dietary Supplement: Carbohydrate 50%; Dietary Supplement: Psyllium; Dietary Supplement: Calcium carbonate
Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PSExperimentalPeriod 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)
Receives: Drug: LIK066; Dietary Supplement: Carbohydrate 50%; Dietary Supplement: Psyllium; Dietary Supplement: Calcium carbonate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 hours on Day 3 of each treatment period

Secondary outcomes (4)

  1. 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.

    Measured: Day 1 to 3 of each treatment period

  2. 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).

    Measured: 24 hours on Day 3 of each treatment period

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

    Average PH of Stool at day 3

    Measured: 24 hours on Day 3 of each treatment period

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

    24 hour average stool weight on day 3

    Measured: 24 hours on Day 3 of each treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2017
  2. Study start21 Jun 2017
  3. Primary completion4 Sep 2017
  4. Study completion4 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03198767
Sponsor's protocol ID
CLIK066B2203
Status last verified
May 2019
First submitted
16 Jun 2017
Last updated
5 Jan 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LIK066, Carbohydrate 50% and Carbohydrate 25% in people with Obesity, run by Novartis Pharmaceuticals at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Episodes of Diarrhea (Part A and Part B) (time frame: 24 hours on Day 3 of each treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03198767.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.

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