Percent Change in Baseline Weight
| Group | Value (percent change) | Spread |
|---|---|---|
| CMS-Alone | -6.1 | 1.3 |
| CMS-Liraglutide | -11.5 | 1.3 |
| Multi-Component Intervention | -11.8 | 1.3 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataShort name MODEL
United States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a 52 week, single center, open-labeled, randomized controlled trial. A total of 150 subjects with obesity, who are free of types 1 and 2 diabetes, as well as contraindications to weight loss, will be randomly assigned to one of three treatment groups: 1) lifestyle counseling, as currently recommended by the Centers for Medicare and Medicaid Services (CMS) (i.e., CMS-Alone); 2) CMS lifestyle counseling plus liraglutide (i.e., CMS-Liraglutide); or 3) CMS-Liraglutide plus a portion-controlled diet (i.e., Multi-Component Intervention). Subjects in all three groups will have 14 brief (15 minute) lifestyle counseling visits the first 24 weeks, followed by monthly visits in weeks 25-52. This is the schedule and duration of counseling visits recommended by CMS. Counseling sessions will be delivered by a physician, nurse practitioner or registered dietitian (RD) working in consultation with the former providers. Subjects in all three groups also will have brief physician visits at weeks 1, 4, 8, 16, 24, 36, and 52 (total of 7 visits). These visits are needed for subjects in both liraglutide groups to monitor their response to the medication. These visits are included for subjects in CMS-Alone to match the intensity of medical care provided the two other groups. The primary outcome is % reduction in initial body weight, as measured from randomization to week 52. Secondary outcomes include the proportion of participants who at week 52 lose \>5%, \>10%, and \>15% of initial weight, as well as % reduction in weight at week 24 and the proportion of participants who meet the three categorical weight losses at this time. The secondary efficacy measures include changes (from randomization to week 52) in cardiovascular disease (CVD) risk factors, glycemic control, mood, quality of life, eating behavior, appetite, sleep, and satisfaction with weight loss. Safety endpoints will include physical examination, adverse events (AEs), standard laboratory tests, and mental health assessed by the Columbia Suicidality Severity Rating Scale (C-SSRS) and Patient Health Questionnaire (PHQ-9). Statistical Analysis. Using a sample size equation for longitudinal clustered samples, a randomization sample of 50 subjects in CMS-Alone, 50 in CMS-Liraglutide, and 50 in the Multi-Component Intervention provides \>80% power to detect the two primary contrasts to be statistically significant. This estimate allows for 20% attrition during the 52-week trial, resulting in approximately 40 treatment completers per group. The ITT longitudinal statistical design will further improve power by allowing the inclusion of available data for non-completers and the adjustment of possible variance reducing baseline covariates.
Active comparator
CMS-Alone
Lifestyle counseling, as currently recommended by the CMS.
Active comparator
CMS-Liraglutide
CMS lifestyle counselling plus liraglutide.
Active comparator
Multi-Component Intervention
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks.
Active comparator
12-Week Extension Study: Phentermine Group
After the 1-year trial, half the participants who join the extension study will be randomized to phentermine 15.0 mg/d in a double-blind fashion, while continuing to take liraglutide. They will also continue to receive monthly lifestyle counseling. To be eligible for the extension study, participants must have been assigned to one of two medication groups in the original study.
Active comparator
12-Week Extension Study: Placebo Group
After the 1-year trial, half the participants who join the extension study will be randomized to placebo in a double-blind fashion, while continuing to take liraglutide. They will also continue to receive monthly lifestyle counseling. To be eligible for the extension study, participants must have been assigned to one of two medication groups in the original study.
Outcomes the sponsor listed as primary.
Percent Change in Baseline Weight
Time frame · Randomization and 52 weeks
Extension Study Primary Outcome: Percent Change in Re-randomization Weight
Time frame · Re-randomization and 12 weeks
Change in Systolic Blood Pressure
Time frame · Randomization and 52 weeks
Change in Diastolic Blood Pressure
Time frame · Randomization and 52 weeks
Change in Heart Rate
Time frame · Randomization and 52 weeks
Change in Waist Circumference
Time frame · Randomization and 52 weeks
Change in Total Cholesterol
Time frame · Randomization and 52 weeks
Change in LDL Cholesterol
Time frame · Randomization and 52 weeks
Change in HDL Cholesterol
Time frame · Randomization and 52 weeks
Change in Triglycerides
Time frame · Randomization and 52 weeks
Change in C Reactive Protein
Time frame · Randomization and 52 weeks
Change in Fasting Glucose
Time frame · Randomization and 52 weeks
Change in HbA1c
Time frame · Randomization and 52 weeks
Change in Fasting Insulin
Time frame · Randomization and 52 weeks
Change in HOMA-IR
Time frame · Randomization and 52 weeks
HOMA-IR is a measurement for insulin resistance and is calculated from: fasting insulin (U/L) x fasting glucose (mg/dL)/405. A decrease from baseline to the end of treatment, a negative value, indicates an improvement
Change in 36-Item Short Form Survey (SF-36) - Physical Component Summary
Time frame · Randomization and 52 weeks
All sub scales are scored from 0 - 100, with higher scores indicating better health. Each component summary is a normed score with a mean of 50 and standard deviation of 10 in the US general population. Higher scores indicate better health. Z-scores are computed for each subscale, which are then converted into a component summary z-score using a weighted formula. The component summary z-score is then converted to a t-distribution with a mean of 50 and standard deviation of 10. Scores are scaled to a T-score with a mean of 50 and standard deviation of 10. Scores above 50 indicate better health.
Change 36-Item Short Form Survey (SF-36) - Mental Component Summary
Time frame · Randomization and 52 weeks
All sub scales are scored from 0 - 100, with higher scores indicating better health. Each component summary is a normed score with a mean of 50 and standard deviation of 10 in the US general population. Higher scores indicate better health. Z-scores are computed for each subscale, which are then converted into a component summary z-score using a weighted formula. The component summary z-score is then converted to a t-distribution with a mean of 50 and standard deviation of 10. Scores are scaled to a T-score with a mean of 50 and standard deviation of 10. Scores above 50 indicate better health.
Change in Patient Health Questionnaire (PHQ-9)
Time frame · Randomization and 52 weeks
PHQ-9 is scored based on a 0-27 scale in which higher scores indicate more severe depression. Values are summed to compute the total score.
Extension Study Secondary Outcome: Change in Systolic Blood Pressure
Time frame · Re-randomization and 12 weeks
Extension Study Secondary Outcome: Change in Diastolic Blood Pressure
Time frame · Re-randomization and 12 weeks
Extension Study Secondary Outcome: Change in Heart Rate
Time frame · Re-randomization and 12 weeks
Extension Study Secondary Outcome: Change in Waist Circumference
Time frame · Re-randomization and 12 weeks
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percent change) | Spread |
|---|---|---|
| CMS-Alone | -6.1 | 1.3 |
| CMS-Liraglutide | -11.5 | 1.3 |
| Multi-Component Intervention | -11.8 | 1.3 |
| Group | Value (percent change) | Spread |
|---|---|---|
| 12-Week Extension Study: Phentermine Group | -1.6 | 0.6 |
| 12-Week Extension Study: Placebo Group | -0.1 | 0.5 |
| Group | Value (mm Hg) | Spread |
|---|---|---|
| CMS-Alone | -14.1 | 2.1 |
| CMS-Liraglutide | -13.3 | 2.1 |
| Multi-Component Intervention | -15.3 | 2.1 |
| Group | Value (mm Hg) | Spread |
|---|---|---|
| CMS-Alone | -3.0 | 1.2 |
| CMS-Liraglutide | -2.9 | 1.2 |
| Multi-Component Intervention | -3.5 | 1.2 |
| Group | Value (Beats per minute) | Spread |
|---|---|---|
| CMS-Alone | -7.4 | 2.0 |
| CMS-Liraglutide | -5.3 | 2.0 |
| Multi-Component Intervention | 9.7 | 2.0 |
| Group | Value (cm) | Spread |
|---|---|---|
| CMS-Alone | -6.5 | 1.3 |
| CMS-Liraglutide | -11.1 | 1.3 |
| Multi-Component Intervention | -12.6 | 1.3 |
| Group | Value (mg/dL) | Spread |
|---|---|---|
| CMS-Alone | -7.0 | 3.5 |
| CMS-Liraglutide | -9.7 | 3.6 |
| Multi-Component Intervention | -10.0 | 3.5 |
| Group | Value (mg/dL) | Spread |
|---|---|---|
| CMS-Alone | -3.3 | 3.1 |
| CMS-Liraglutide | -9.6 | 3.1 |
| Multi-Component Intervention | -9.4 | 3.1 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| CMS-AloneLifestyle counseling, as currently recommended by the CMS. CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian. | 0 / 50 | 2 / 50 | 21 / 50 |
| CMS-LiraglutideCMS lifestyle counselling plus liraglutide. CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian. Liraglutide 3.0mg: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection. | 0 / 50 | 0 / 50 | 42 / 50 |
| Multi-Component InterventionCMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet. CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian. Liraglutide 3.0mg: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection. Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4. | 0 / 50 | 3 / 50 | 44 / 50 |
| 12-Week Extension Study: Phentermine GroupAfter the 1-year trial, half the participants who join the extension study will be randomized to phentermine 15.0 mg/d in a double-blind fashion, while continuing to take liraglutide. They will also continue to receive monthly lifestyle counseling. CMS-recommended lifestyle counseling: 4 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian. Liraglutide 3.0mg: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection. Phentermine 15 MG | 1 / 22 | 1 / 22 | 12 / 22 |
| 12-Week Extension Study: Placebo GroupAfter the 1-year trial, half the participants who join the extension study will be randomized to placebo in a double-blind fashion, while continuing to take liraglutide. They will also continue to receive monthly lifestyle counseling. CMS-recommended lifestyle counseling: 4 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian. Liraglutide 3.0mg: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection. Placebo Oral Tablet | 0 / 23 | 0 / 23 | 11 / 23 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
3 studies on this page
Indexing hint: Randomized controlled trial · 2020
Tronieri et al. 2020International journal of obesity (2005)cited by 55
PMID 30926955PMC6766432DOI 10.1038/s41366-019-0348-6PUB-30926955
Indexing hint: Randomized controlled trial · 2019
Wadden et al. 2019Obesity (Silver Spring, Md.)cited by 78
PMID 30421856PMC6800068DOI 10.1002/oby.22359PUB-30421856
Indexing hint: Randomized controlled trial · 2019
Tronieri et al. 2019Metabolism: clinical and experimentalcited by 14
PMID 30902750PMC6571049DOI 10.1016/j.metabol.2019.03.005PUB-30902750
Who could join, as posted.
PepBank is a research reference. Talk to a doctor before you use any peptide.
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated