Trial · NCT01272219
Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE™ - Obesity and Pre-diabetes
NCT01272219, Phase 3, Completed, Novo Nordisk A/S; results first posted 2015-02-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE™ - Obesity and Pre-diabetes. Trials, record NCT01272219. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01272219
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE™ - Obesity and Pre-diabetes
- NCT number
- NCT01272219
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,731 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Interventions
- liraglutide, placebo, liraglutide, placebo
- First posted
- 2011-01-07
- Last updated
- 2018-01-19
- Other registries' IDs
- eudract:2008-001049-24
- Results first posted
- 2015-02-09
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Fasting Body Weight | Week 0, Week 56 | The observed mean change from baseline in fasting body weight (%) after 56-weeks of treatment (main treatment period). |
| Primary | Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight. | At Week 56 | Percentage of subjects losing at least 5% of baseline fasting body weight after 56-weeks of treatment (main treatment period). |
| Primary | Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight | At 56 weeks | Percentage of subjects losing \>10% of baseline fasting body weight after 56-weeks of treatment (main treatment period). |
| Primary | Proportion of Subjects With Onset of Type 2 Diabetes | At 160 weeks | Proportion of subjects with onset of Type 2 diabetes mellitus (T2DM) at week 160 (main + extension treatment period) among subjects with pre-diabetes at baseline - evaluated as time to onset of T2DM. Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period). |
| Secondary | Change From Baseline in Waist Circumference (cm) | Week 0, Week 56 | The observed mean change from baseline in waist circumference (cm) after 56-weeks of treatment (main treatment period). |
| Secondary | Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline) | Week 0, week 160 | The observed mean change from baseline in waist circumference (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period). |
| Secondary | Pre-diabetes Status After 56 Weeks of Treatment | Week 0, Week 56 | Observed percentage of subjects with pre-diabetes status after 56 weeks of treatment (main treatment period). |
| Secondary | Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment | Week 0, week 160 | Observed percentage of subjects (subjects with pre-diabetes at baseline) with pre-diabetes status after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period). |
| Secondary | Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline) | Week 0, week 160 | The observed mean change from baseline in fasting body weight (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period). |
| Secondary | Proportion of Subjects Losing at Least 5% and Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (Subjects With Pre-diabetes at Baseline) | At 160 weeks | Percentage of subjects losing \>=5% and percentage of subjects losing \>10% of baseline fasting body weight (pre-diabetic subjects at baseline) after 160-weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Fasting Body Weight | Week 0, Week 56 | The full analysis set (FAS) included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using last observation carried forward (LOCF). | percent change | MEAN |
| PRIMARY | Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight. | At Week 56 | The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF. | percentage of subjects | NUMBER |
| PRIMARY | Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight | At 56 weeks | The FAS) included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF. | percentage of subjects | NUMBER |
| PRIMARY | Proportion of Subjects With Onset of Type 2 Diabetes | At 160 weeks | Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF. | Subject | NUMBER |
| SECONDARY | Change From Baseline in Waist Circumference (cm) | Week 0, Week 56 | The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF. | cm | MEAN |
| SECONDARY | Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline) | Week 0, week 160 | Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF. | cm | MEAN |
| SECONDARY | Pre-diabetes Status After 56 Weeks of Treatment | Week 0, Week 56 | The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF. | percentage of subjects | NUMBER |
| SECONDARY | Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment | Week 0, week 160 | Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF. | percentage of subjects | NUMBER |
| SECONDARY | Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline) | Week 0, week 160 | Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF. | percent change | MEAN |
| SECONDARY | Proportion of Subjects Losing at Least 5% and Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (Subjects With Pre-diabetes at Baseline) | At 160 weeks | Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF. | percentage of subjects | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Fasting Body Weight | Liraglutide 3.0 mg (56-Week) | -7.98 | Standard Deviation 6.67 | percent change | |
| Change From Baseline in Fasting Body Weight | Liraglutide Placebo (56-Week) | -2.62 | Standard Deviation 5.74 | percent change | |
| Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight. | Liraglutide 3.0 mg (56-Week) | 63.2 | percentage of subjects | ||
| Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight. | Liraglutide Placebo (56-Week) | 27.1 | percentage of subjects | ||
| Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight | Liraglutide 3.0 mg (56-Week) | 33.1 | percentage of subjects | ||
| Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight | Liraglutide Placebo (56-Week) | 10.6 | percentage of subjects | ||
| Proportion of Subjects With Onset of Type 2 Diabetes | Liraglutide 3.0 mg (160-Week) | 26 | Subject | ||
| Proportion of Subjects With Onset of Type 2 Diabetes | Liraglutide Placebo (160-Week) | 46 | Subject | ||
| Change From Baseline in Waist Circumference (cm) | Liraglutide 3.0 mg (56-Week) | -8.19 | Standard Deviation 7.31 | cm | |
| Change From Baseline in Waist Circumference (cm) | Liraglutide Placebo (56-Week) | -3.94 | Standard Deviation 6.58 | cm |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow66
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Period: Week 0 to Week 56 | STARTED | Liraglutide 3.0 mg, no Pre-diabetes | 959 | |
| Main Period: Week 0 to Week 56 | STARTED | Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68) | 0 | |
| Main Period: Week 0 to Week 56 | STARTED | Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68) | 0 | |
| Main Period: Week 0 to Week 56 | STARTED | Liraglutide Placebo, no Pre-diabetes | 487 | |
| Main Period: Week 0 to Week 56 | STARTED | Liraglutide 3.0 mg, Pre-diabetes | 1,528 | |
| Main Period: Week 0 to Week 56 | STARTED | Liraglutide Placebo, Pre-diabetes | 757 | |
| Main Period: Week 0 to Week 56 | Exposed | Liraglutide 3.0 mg, no Pre-diabetes | 957 | |
| Main Period: Week 0 to Week 56 | Exposed | Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68) | 0 | |
| Main Period: Week 0 to Week 56 | Exposed | Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68) | 0 | |
| Main Period: Week 0 to Week 56 | Exposed | Liraglutide Placebo, no Pre-diabetes | 487 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 participant flowAdverse events1,392
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 | Abdominal pain | Gastrointestinal disorders | Liraglutide 3.0 mg, Pre-diabetes | 112 | 1,524 | 150 |
| other | Abdominal pain | Gastrointestinal disorders | Liraglutide Placebo, Pre-diabetes | 37 | 755 | 49 |
| other | Abdominal pain | Gastrointestinal disorders | Liraglutide 3.0 mg, no Pre-diabetes | 62 | 957 | 79 |
| other | Abdominal pain | Gastrointestinal disorders | Liraglutide Placebo, no Pre-diabetes | 19 | 487 | 22 |
| other | Abdominal pain upper | Gastrointestinal disorders | Liraglutide 3.0 mg, Pre-diabetes | 110 | 1,524 | 137 |
| other | Abdominal pain upper | Gastrointestinal disorders | Liraglutide Placebo, Pre-diabetes | 40 | 755 | 49 |
| other | Abdominal pain upper | Gastrointestinal disorders | Liraglutide 3.0 mg, no Pre-diabetes | 63 | 957 | 84 |
| other | Abdominal pain upper | Gastrointestinal disorders | Liraglutide Placebo, no Pre-diabetes | 18 | 487 | 20 |
| other | Constipation | Gastrointestinal disorders | Liraglutide 3.0 mg, Pre-diabetes | 333 | 1,524 | 422 |
| other | Constipation | Gastrointestinal disorders | Liraglutide Placebo, Pre-diabetes | 85 | 755 | 100 |
1 to 10 of 1,392Source ClinicalTrials.gov
See all 1,392 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Liraglutide 3.0 mg, Pre-diabetes | ||
| Total, all-cause mortality | Liraglutide Placebo, Pre-diabetes | ||
| Total, all-cause mortality | Liraglutide 3.0 mg, no Pre-diabetes | ||
| Total, all-cause mortality | Liraglutide Placebo, no Pre-diabetes | ||
| Total, other adverse events | Liraglutide 3.0 mg, Pre-diabetes | 1,342 | 1,524 |
| Total, other adverse events | Liraglutide Placebo, Pre-diabetes | 586 | 755 |
| Total, other adverse events | Liraglutide 3.0 mg, no Pre-diabetes | 843 | 957 |
| Total, other adverse events | Liraglutide Placebo, no Pre-diabetes | 345 | 487 |
| Total, serious adverse events | Liraglutide 3.0 mg, Pre-diabetes | 230 | 1,524 |
| Total, serious adverse events | Liraglutide Placebo, Pre-diabetes | 96 | 755 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers17
The papers the trial lists on ClinicalTrials.gov.
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/NCT01272219
GET https://conductscience.org/api/trials/v1/NCT01272219/results?page=2