Trial · NCT00422058
The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes
NCT00422058, Phase 2, Completed, Novo Nordisk A/S; results first posted 2010-10-28
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes. Trials, record NCT00422058. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00422058
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes
- NCT number
- NCT00422058
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 564 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Interventions
- liraglutide, orlistat, placebo
- First posted
- 2007-01-15
- Last updated
- 2017-11-01
- Other registries' IDs
- eudract:2006-004481-13
- Results first posted
- 2010-10-28
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Body Weight at Week 20 | Week 0, week 20 | Calculated as mean body weight at week 20 - baseline |
| Secondary | Mean Change From Baseline in Body Weight at Week 104 | Week 0, week 104 | Calculated as mean body weight at week 104 - baseline |
| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 20 | Week 0, week 20 | Calculated as mean fasting plasma glucose at week 20 - baseline |
| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 104 | Week 0, week 104 | Calculated as mean fasting plasma glucose at week 104 - baseline |
| Secondary | Change From Baseline in Fasting Insulin at Week 20 | Week 0, week 20 | Calculated as mean fasting insulin at week 20 - baseline |
| Secondary | Change From Baseline in Fasting Insulin at Week 104 | Week 0, week 104 | Calculated as mean fasting insulin at week 104 - baseline |
| Secondary | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20 | Week 0, week 20 | Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 20 - baseline |
| Secondary | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104 | Week 0, week 104 | Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 104 - baseline |
| Secondary | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20 | Week 0, week 20 | Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 20-baseline. High hsCRP level is associated with greater cardiovascular risk |
| Secondary | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104 | Week 0, week 104 | Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 104- baseline. High hsCRP level is associated with greater cardiovascular risk |
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 | Mean Change From Baseline in Body Weight at Week 20 | Week 0, week 20 | ITT (intention to treat) analysis set using LOCF (last observation carried forward) is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product. | kg | MEAN |
| SECONDARY | Mean Change From Baseline in Body Weight at Week 104 | Week 0, week 104 | ITT (intention to treat) analysis set using LOCF (last observation carried forward) is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product. | kg | MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose at Week 20 | Week 0, week 20 | ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product | mmol/L | MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose at Week 104 | Week 0, week 104 | ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product | mmol/L | MEAN |
| SECONDARY | Change From Baseline in Fasting Insulin at Week 20 | Week 0, week 20 | ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied). | pmol/L | MEAN |
| SECONDARY | Change From Baseline in Fasting Insulin at Week 104 | Week 0, week 104 | ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied). | pmol/L | MEAN |
| SECONDARY | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20 | Week 0, week 20 | ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied). | percentage (%) of total haemoglobin | MEAN |
| SECONDARY | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104 | Week 0, week 104 | ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied). | percentage (%) of total haemoglobin | MEAN |
| SECONDARY | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20 | Week 0, week 20 | ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied). | mg/L | MEAN |
| SECONDARY | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104 | Week 0, week 104 | ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied). | mg/L | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group264
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Body Weight at Week 20 | Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Baseline | 97.3 | Standard Deviation 12.3 | kg |
| Mean Change From Baseline in Body Weight at Week 20 | Lira 1.2 mg/Lira 3.0 mg | Baseline | 96.4 | Standard Deviation 13.4 | kg |
| Mean Change From Baseline in Body Weight at Week 20 | Lira 1.8 mg/Lira 3.0 mg | Baseline | 98.0 | Standard Deviation 12.5 | kg |
| Mean Change From Baseline in Body Weight at Week 20 | Lira 2.4 mg/Lira 3.0 mg | Baseline | 98.4 | Standard Deviation 13.1 | kg |
| Mean Change From Baseline in Body Weight at Week 20 | Liraglutide 3.0 mg | Baseline | 97.5 | Standard Deviation 13.8 | kg |
| Mean Change From Baseline in Body Weight at Week 20 | Orlistat | Baseline | 96.0 | Standard Deviation 11.7 | kg |
| Mean Change From Baseline in Body Weight at Week 20 | Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change at Week 20 | -3.0 | Standard Deviation 3.3 | kg |
| Mean Change From Baseline in Body Weight at Week 20 | Lira 1.2 mg/Lira 3.0 mg | Change at Week 20 | -5.1 | Standard Deviation 3.5 | kg |
| Mean Change From Baseline in Body Weight at Week 20 | Lira 1.8 mg/Lira 3.0 mg | Change at Week 20 | -5.9 | Standard Deviation 5.0 | kg |
| Mean Change From Baseline in Body Weight at Week 20 | Lira 2.4 mg/Lira 3.0 mg | Change at Week 20 | -6.6 | Standard Deviation 4.6 | kg |
1 to 10 of 264Source ClinicalTrials.gov
See all 264 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind, Week 0-20 | STARTED | Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | 98 | |
| Double-Blind, Week 0-20 | STARTED | Lira 1.2 mg/Lira 3.0 mg | 95 | |
| Double-Blind, Week 0-20 | STARTED | Lira 1.8 mg/Lira 3.0 mg | 90 | |
| Double-Blind, Week 0-20 | STARTED | Lira 2.4 mg/Lira 3.0 mg | 93 | |
| Double-Blind, Week 0-20 | STARTED | Liraglutide 3.0 mg | 93 | |
| Double-Blind, Week 0-20 | STARTED | Orlistat | 95 | |
| Double-Blind, Week 0-20 | COMPLETED | Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | 79 | |
| Double-Blind, Week 0-20 | COMPLETED | Lira 1.2 mg/Lira 3.0 mg | 85 | |
| Double-Blind, Week 0-20 | COMPLETED | Lira 1.8 mg/Lira 3.0 mg | 74 | |
| Double-Blind, Week 0-20 | COMPLETED | Lira 2.4 mg/Lira 3.0 mg | 73 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events546
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 | Palpitations | Cardiac disorders | Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | 0 | 98 | 0 |
| other | Palpitations | Cardiac disorders | Lira 1.2 mg/Lira 3.0 mg | 0 | 95 | 0 |
| other | Palpitations | Cardiac disorders | Lira 1.8 mg/Lira 3.0 mg | 6 | 90 | 6 |
| other | Palpitations | Cardiac disorders | Lira 2.4 mg/Lira 3.0 mg | 0 | 93 | 0 |
| other | Palpitations | Cardiac disorders | Liraglutide 3.0 mg | 0 | 93 | 0 |
| other | Palpitations | Cardiac disorders | Orlistat | 0 | 95 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | 0 | 98 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Lira 1.2 mg/Lira 3.0 mg | 0 | 95 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Lira 1.8 mg/Lira 3.0 mg | 0 | 90 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Lira 2.4 mg/Lira 3.0 mg | 0 | 93 | 0 |
1 to 10 of 546Source ClinicalTrials.gov
See all 546 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | ||
| Total, all-cause mortality | Lira 1.2 mg/Lira 3.0 mg | ||
| Total, all-cause mortality | Lira 1.8 mg/Lira 3.0 mg | ||
| Total, all-cause mortality | Lira 2.4 mg/Lira 3.0 mg | ||
| Total, all-cause mortality | Liraglutide 3.0 mg | ||
| Total, all-cause mortality | Orlistat | ||
| Total, other adverse events | Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | 90 | 98 |
| Total, other adverse events | Lira 1.2 mg/Lira 3.0 mg | 90 | 95 |
| Total, other adverse events | Lira 1.8 mg/Lira 3.0 mg | 86 | 90 |
| Total, other adverse events | Lira 2.4 mg/Lira 3.0 mg | 89 | 93 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers6
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/NCT00422058
GET https://conductscience.org/api/trials/v1/NCT00422058/results?page=2