Trial · NCT03100058
A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults
NCT03100058, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2020-02-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults. Trials, record NCT03100058. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03100058
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults
- NCT number
- NCT03100058
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 460 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Obesity, Overweight
- Interventions
- LIK066, Placebo
- First posted
- 2017-04-04
- Last updated
- 2020-02-06
- Other registries' IDs
- eudract:2016-002868-14
- Results first posted
- 2020-02-06
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Body Weight at 24 Weeks | Baseline, Week 24 (Epoch 3) | Dose-response relationship of two dose regimens of LIK066 as measured by the percent change from baseline in body weight relative to placebo after 24 weeks of treatment |
| Secondary | Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Overall Study | Baseline, Week 24 | Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline |
| Secondary | Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Subgroups | Baseline, Week 24 | Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline for dysglycemic, normoglycemic, Type 2 Diabetes Mellitus (T2DM) |
| Secondary | Percentage Change From Baseline on Waist Circumference | Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4) | Waist circumference will be measured to the nearest 0.1cm in a standing position, at the end of a normal expiration, using a tape at the level of the iliac crest. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) in Type 2 Diabetes Mellitus Patients (T2DM) | Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4) | FPG will be measured from a blood sample obtained after an overnight fast (at least 8h after last evening food intake). |
| Secondary | Change From Baseline in Glycated Hemoglobin A1c (HbA1c) in Type 2 Diabetes Mellitus Patients (T2DM) | Baseline, Week 24 (Epoch 3), Week 24 to week 48 (Epoch 4) | HbA1c will be measured from a blood sample obtained at indicated visits and will be analyzed at a central laboratory. |
| Secondary | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline, Week 24 (Epoch 3) Week 24 to Week 48 (Epoch 4) | At each study visit (baseline, week 24, Week 48), after the subject has been sitting for 5 minutes with the back supported and both feet placed on the floor, SBP and DBP will be measured |
| Secondary | Change From Baseline in 24-hour Urinary Glucose Excretion | Baseline, week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4) | Urinary glucose excretion will be measured from 24-hour urinary collection at indicated visits and will be analyzed at a central laboratory. |
| Secondary | Percentage Change in Weight in the Overall Population and by Subgroups (Epoch 4) | Between Week 24 and Week 48 (Epoch 4) | Between -treatment analysis of percentage change from Week 24 in body weight (kg) at Week 48 (Epoch 4) |
| Secondary | Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Calcium Excretion | Baseline, Week 24 | Evaluation of 24-hour urinary calcium excretion after 24 week of treatment. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Body Weight at 24 Weeks | Baseline, Week 24 (Epoch 3) | Full Analysis Set | Percent change | MEAN |
| SECONDARY | Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Overall Study | Baseline, Week 24 | Full Analysis Set | Percentage | NUMBER |
| SECONDARY | Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Subgroups | Baseline, Week 24 | Full Analysis Set | Percentage | NUMBER |
| SECONDARY | Percentage Change From Baseline on Waist Circumference | Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4) | Full Analysis Set | Percentage Change | MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) in Type 2 Diabetes Mellitus Patients (T2DM) | Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4) | Full Analysis Set | mmol/L | MEAN |
| SECONDARY | Change From Baseline in Glycated Hemoglobin A1c (HbA1c) in Type 2 Diabetes Mellitus Patients (T2DM) | Baseline, Week 24 (Epoch 3), Week 24 to week 48 (Epoch 4) | Full Analysis Set | mmol/L | MEAN |
| SECONDARY | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline, Week 24 (Epoch 3) Week 24 to Week 48 (Epoch 4) | Full Analysis Set | mmHg | MEAN |
| SECONDARY | Change From Baseline in 24-hour Urinary Glucose Excretion | Baseline, week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4) | Full Analysis Set | mmol/24hr | MEAN |
| SECONDARY | Percentage Change in Weight in the Overall Population and by Subgroups (Epoch 4) | Between Week 24 and Week 48 (Epoch 4) | Full Analysis Set | Percentage | MEAN |
| SECONDARY | Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Calcium Excretion | Baseline, Week 24 | Full Analysis Set | mmol/24hr | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group363
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Body Weight at 24 Weeks | LIK066 2.5mg qd (Epoch 3) | -1.24 | 95% Confidence Interval -2.50 to -0.45 | Percent change | |
| Percent Change From Baseline in Body Weight at 24 Weeks | LIK066 10mg qd (Epoch 3) | -2.04 | 95% Confidence Interval -3.36 to -0.88 | Percent change | |
| Percent Change From Baseline in Body Weight at 24 Weeks | LIK066 50mg qd (Epoch 3) | -3.52 | 95% Confidence Interval -4.62 to -1.87 | Percent change | |
| Percent Change From Baseline in Body Weight at 24 Weeks | LIK066 150mg qd (Epoch 3) | -4.37 | 95% Confidence Interval -5.36 to -3.37 | Percent change | |
| Percent Change From Baseline in Body Weight at 24 Weeks | LIK066 2.5mg Bid (Epoch 3) | -1.67 | 95% Confidence Interval -2.61 to -0.27 | Percent change | |
| Percent Change From Baseline in Body Weight at 24 Weeks | LIK066 5mg Bid (Epoch 3) | -2.51 | 95% Confidence Interval -3.94 to -1.32 | Percent change | |
| Percent Change From Baseline in Body Weight at 24 Weeks | LIK066 25mg Bid (Epoch 3) | -4.06 | 95% Confidence Interval -5.52 to -2.87 | Percent change | |
| Percent Change From Baseline in Body Weight at 24 Weeks | LIK066 50mg Bid (Epoch 3) | -4.47 | 95% Confidence Interval -5.49 to -3.48 | Percent change | |
| Percent Change From Baseline in Body Weight at 24 Weeks | Placebo (Epoch 3) | -0.63 | 95% Confidence Interval -1.56 to 0.37 | Percent change | |
| Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Overall Study | LIK066 2.5mg qd (Epoch 3) | >=5% | 26.3 | Percentage |
1 to 10 of 363Source ClinicalTrials.gov
See all 363 results by groupParticipant flow78
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Epoch 3 (24 Weeks of Treatment) | STARTED | LIK066 2.5mg qd (Epoch 3) | 38 | |
| Epoch 3 (24 Weeks of Treatment) | STARTED | LIK066 10mg qd (Epoch 3) | 38 | |
| Epoch 3 (24 Weeks of Treatment) | STARTED | LIK066 50mg qd (Epoch 3) | 38 | |
| Epoch 3 (24 Weeks of Treatment) | STARTED | LIK066 150mg qd (Epoch 3) | 77 | |
| Epoch 3 (24 Weeks of Treatment) | STARTED | LIK066 2.5mg Bid (Epoch 3) | 38 | |
| Epoch 3 (24 Weeks of Treatment) | STARTED | LIK066 5mg Bid (Epoch 3) | 39 | |
| Epoch 3 (24 Weeks of Treatment) | STARTED | LIK066 25mg Bid (Epoch 3) | 38 | |
| Epoch 3 (24 Weeks of Treatment) | STARTED | LIK066 50mg Bid (Epoch 3) | 76 | |
| Epoch 3 (24 Weeks of Treatment) | STARTED | Placebo (Epoch 3) | 78 | |
| Epoch 3 (24 Weeks of Treatment) | STARTED | LIK066 qd/LIK066 25 mg qd (Epoch 4) | 0 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 participant flowAdverse events3,610
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 | Anaemia | Blood and lymphatic system disorders | LIK066 2.5 mg qd (Epoch 3)/25 mg qd (Epoch 4) | 0 | 38 | |
| other | Anaemia | Blood and lymphatic system disorders | LIK066 10 mg qd/25 mg qd | 0 | 38 | |
| other | Anaemia | Blood and lymphatic system disorders | LIK066 50 mg qd/25 mg qd | 0 | 38 | |
| other | Anaemia | Blood and lymphatic system disorders | LIK066 150 mg qd/25 mg qd | 0 | 77 | |
| other | Anaemia | Blood and lymphatic system disorders | LIK066 2.5 mg Bid/35 mg qd | 1 | 38 | |
| other | Anaemia | Blood and lymphatic system disorders | LIK066 5 mg Bid/35 mg qd | 0 | 39 | |
| other | Anaemia | Blood and lymphatic system disorders | LIK066 25 mg Bid/35 mg qd | 0 | 38 | |
| other | Anaemia | Blood and lymphatic system disorders | LIK066 50 mg Bid/35 mg qd | 0 | 76 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo/LIK066 25 mg qd (Epoch 4) | 1 | 40 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo/Placebo | 0 | 38 |
1 to 10 of 3,610Source ClinicalTrials.gov
See all 3,610 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LIK066 2.5 mg qd (Epoch 3)/25 mg qd (Epoch 4) | 0 | 38 |
| Total, all-cause mortality | LIK066 10 mg qd/25 mg qd | 1 | 38 |
| Total, all-cause mortality | LIK066 50 mg qd/25 mg qd | 0 | 38 |
| Total, all-cause mortality | LIK066 150 mg qd/25 mg qd | 0 | 77 |
| Total, all-cause mortality | LIK066 2.5 mg Bid/35 mg qd | 1 | 38 |
| Total, all-cause mortality | LIK066 5 mg Bid/35 mg qd | 0 | 39 |
| Total, all-cause mortality | LIK066 25 mg Bid/35 mg qd | 0 | 38 |
| Total, all-cause mortality | LIK066 50 mg Bid/35 mg qd | 0 | 76 |
| Total, all-cause mortality | Placebo/LIK066 25 mg qd (Epoch 4) | 0 | 40 |
| Total, all-cause mortality | Placebo/Placebo | 0 | 38 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT03100058
GET https://conductscience.org/api/trials/v1/NCT03100058/results?page=2