Trial · NCT03320941
A Dose-finding Study to Evaluate the Change in Weight After Treatment With LIK066 in Japanese Patients With Obesity
NCT03320941, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2019-10-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Dose-finding Study to Evaluate the Change in Weight After Treatment With LIK066 in Japanese Patients With Obesity. Trials, record NCT03320941. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03320941
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Dose-finding Study to Evaluate the Change in Weight After Treatment With LIK066 in Japanese Patients With Obesity
- NCT number
- NCT03320941
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 126 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Obesity
- Interventions
- LIK066, Placebo
- First posted
- 2017-10-25
- Last updated
- 2024-06-26
- Results first posted
- 2019-10-02
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change From Baseline in Body Weight at Week 12 | Baseline, Week 12 | The dose-response relationship of LIK066 as measured by percent change from baseline in body weight relative to placebo after 12 weeks of treatment. |
| Secondary | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | Baseline, Week 12 | The responder rates according to percentage decrease in body weight either ≥ 3%, ≥ 5% or ≥ 10%, from baseline at Week 12, for the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12 No Statistical Analysis for \>=5% and \>=10% was not calculated due to division by zero |
| Secondary | Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM) | Baseline, Week 12 | The dose-response relationship for weight loss in dysglycemic participants and participants with T2DM. Percentage change from baseline in body weight at Week 12. |
| Secondary | Change From Baseline at Week 12 on Waist Circumference at Umbilical Level | Baseline, Week 12 | Waist circumference will be measured to the nearest 0.1 cm in a standing position, at the end of a normal expiration, using a tape at the level of umbilicus. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12 |
| Secondary | Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c) | Baseline, Week 12 | HbA1c will be measured from a blood sample obtained and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12 |
| Secondary | Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG) | Baseline, Week 12 | FPG will be measured from a blood sample obtained after an overnight fast (at least 8h after last evening food intake) at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12 |
| Secondary | Change From Baseline at Week 12 on Systolic Blood Pressure (SBP) | Baseline, Week 12 | After the subject has been sitting for 5 minutes with the back supported and both feet placed on the floor, SBP will be measured three times using the automatic BP monitor and an appropriate size cuff. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12 |
| Secondary | Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP) | Baseline, Week 12 | After the subject has been sitting for 5 minutes with the back supported and both feet placed on the floor, DBP will be measured three times using the automatic BP monitor and an appropriate size cuff. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12 |
| Secondary | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG) | Baseline, Week 12 | Fasting lipid profile (Triglycerides (TG)), will be measured on blood samples obtained after an overnight fast and analyzed at a central laboratory For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12 |
| Secondary | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol | Baseline, Week 12 | Fasting lipid profile (total cholesterol), will be measured on blood samples obtained after an overnight fast and analyzed at a central laboratory For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Change From Baseline in Body Weight at Week 12 | Baseline, Week 12 | Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study drug | Percent Change | NUMBER |
| SECONDARY | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | Baseline, Week 12 | Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study drug | Percentage of Participants | NUMBER |
| SECONDARY | Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM) | Baseline, Week 12 | Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126 | percentage change | NUMBER |
| SECONDARY | Change From Baseline at Week 12 on Waist Circumference at Umbilical Level | Baseline, Week 12 | Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126 | cm | MEAN |
| SECONDARY | Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c) | Baseline, Week 12 | Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126 | Percentage | MEAN |
| SECONDARY | Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG) | Baseline, Week 12 | Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126 | mmol/L | MEAN |
| SECONDARY | Change From Baseline at Week 12 on Systolic Blood Pressure (SBP) | Baseline, Week 12 | Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126 | mmHg | MEAN |
| SECONDARY | Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP) | Baseline, Week 12 | Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126 | mmHg | MEAN |
| SECONDARY | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG) | Baseline, Week 12 | Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126 | Percentage | MEAN |
| SECONDARY | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol | Baseline, Week 12 | Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126 | Percentage | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group289
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Change From Baseline in Body Weight at Week 12 | LIK066 2.5mg qd | -1.86 | 95% Confidence Interval -2.59 to -0.67 | Percent Change | |
| Percentage Change From Baseline in Body Weight at Week 12 | LIK066 10mg qd | -2.84 | 95% Confidence Interval -3.79 to -2.16 | Percent Change | |
| Percentage Change From Baseline in Body Weight at Week 12 | LIK066 25 mg qd | -3.41 | 95% Confidence Interval -3.96 to -2.84 | Percent Change | |
| Percentage Change From Baseline in Body Weight at Week 12 | LIK066 50 mg qd | -3.80 | 95% Confidence Interval -4.48 to -3.17 | Percent Change | |
| Percentage Change From Baseline in Body Weight at Week 12 | Placebo | 0.11 | 95% Confidence Interval -0.90 to 0.97 | Percent Change | |
| Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | LIK066 2.5mg qd | >= 3% | 15.8 | Percentage of Participants | |
| Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | LIK066 10mg qd | >= 3% | 55.6 | Percentage of Participants | |
| Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | LIK066 25 mg qd | >= 3% | 50.0 | Percentage of Participants | |
| Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | LIK066 50 mg qd | >= 3% | 56.7 | Percentage of Participants | |
| Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | Placebo | >= 3% | 7.1 | Percentage of Participants |
1 to 10 of 289Source ClinicalTrials.gov
See all 289 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LIK066 2.5mg qd | 19 | |
| Overall Study | STARTED | LIK066 10mg qd | 19 | |
| Overall Study | STARTED | LIK066 25 mg qd | 28 | |
| Overall Study | STARTED | LIK066 50 mg qd | 31 | |
| Overall Study | STARTED | Placebo | 29 | |
| Overall Study | COMPLETED | LIK066 2.5mg qd | 19 | |
| Overall Study | COMPLETED | LIK066 10mg qd | 19 | |
| Overall Study | COMPLETED | LIK066 25 mg qd | 28 | |
| Overall Study | COMPLETED | LIK066 50 mg qd | 30 | |
| Overall Study | COMPLETED | Placebo | 29 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events165
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vertigo | Ear and labyrinth disorders | LIK066 2.5mg qd | 0 | 19 | |
| other | Vertigo | Ear and labyrinth disorders | LIK066 10mg qd | 1 | 19 | |
| other | Vertigo | Ear and labyrinth disorders | LIK066 25mg qd | 0 | 28 | |
| other | Vertigo | Ear and labyrinth disorders | LIK066 50mg qd | 0 | 31 | |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 0 | 29 | |
| other | Diarrhoea | Gastrointestinal disorders | LIK066 2.5mg qd | 0 | 19 | |
| other | Diarrhoea | Gastrointestinal disorders | LIK066 10mg qd | 0 | 19 | |
| other | Diarrhoea | Gastrointestinal disorders | LIK066 25mg qd | 4 | 28 | |
| other | Diarrhoea | Gastrointestinal disorders | LIK066 50mg qd | 12 | 31 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 2 | 29 |
1 to 10 of 165Source ClinicalTrials.gov
See all 165 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LIK066 2.5mg qd | 0 | 19 |
| Total, all-cause mortality | LIK066 10mg qd | 0 | 19 |
| Total, all-cause mortality | LIK066 25mg qd | 0 | 28 |
| Total, all-cause mortality | LIK066 50mg qd | 0 | 31 |
| Total, all-cause mortality | Placebo | 0 | 29 |
| Total, other adverse events | LIK066 2.5mg qd | 10 | 19 |
| Total, other adverse events | LIK066 10mg qd | 12 | 19 |
| Total, other adverse events | LIK066 25mg qd | 13 | 28 |
| Total, other adverse events | LIK066 50mg qd | 20 | 31 |
| Total, other adverse events | Placebo | 9 | 29 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32072763 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03320941
GET https://conductscience.org/api/trials/v1/NCT03320941/results?page=2