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Metabolism and Nutrition DisorderPhase 3NCT00781937

Comparison of Liraglutide Versus Placebo in Weight Loss Maintenance in Obese Subjects: SCALE - Maintenance

A Phase 3 study testing liraglutide in people with Metabolism and Nutrition Disorder and Obesity, run by Novo Nordisk A/S at 37 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This trial is conducted in North America. The aim of this clinical trial is to evaluate the potential of liraglutide to maintain long term weight loss in obese non-diabetic subjects, as well as in overweight subjects who have medical problems such as hypertension (high blood pressure) or dyslipidaemia (an abnormal… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metabolism and Nutrition Disorder, Obesity
What is being tested?
liraglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
422 participants
Where
37 sitesin 2 countries
Study dates
30 Oct 2008to 1 Sep 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Body Mass Index (BMI) of either 30 kg/m^2 or more or BMI of less than 30 kg/m^2 to 27 kg/m^2 with presence of co-morbidities
  • Stable body weight during the previous 3 months (less than 5 kg self-reported weight change)
  • Previously undergone dietary weight loss and was not able to maintain reduced weight

Who cannot join

  • Diagnosis of type 1 or type 2 diabetes
  • Previous treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (including liraglutide or exenatide), within the last 3 months
  • Visit 1 thryoid stimulating hormone (TSH) outside of the range of 0.4-6.0 mIU/L
  • History of chronic pancreatitis or idiopathic acute pancreatitis
  • Obesity induced by other endocrinologic disorders (e.g., Cushing Syndrome)
  • Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial
Show all 11Show fewer
  • Current participation in an organized diet reduction program (or within the last 3 months)
  • Currently using or have used within three months before this trial: pramlintide, sibutramine, orlistat, zonisamide, topiramate, phenteremine, or metformin
  • Previous surgical treatment for obesity (excluding liposuction if performed more than one year before trial entry)
  • History of major depressive disorder or a PHQ-9 (Patient Health Questionnaire-9) score of more than 15 within the last 2 years or history of other severe psychiatric disorders or diagnosis of an eating disorder
  • Subjects with a lifetime history of a suicide attempt or history of any suicidal behavior within the past month before entry into the trial

Trial locations and contacts

37 sites in 2 countries.

37 sites in 2 countries

United States27 sites

  • Novo Nordisk Investigational Site

    Atlanta, Georgia, 30106

  • Novo Nordisk Investigational Site

    Butte, Montana, 59701

  • Novo Nordisk Investigational Site

    Charleston, South Carolina, 29406

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio, 45236

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio, 45245

  • Novo Nordisk Investigational Site

    Colorado Springs, Colorado, 80909

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75246

  • Novo Nordisk Investigational Site

    Endwell, New York, 13760

  • Novo Nordisk Investigational Site

    Goodyear, Arizona, 85395

  • Novo Nordisk Investigational Site

    Hialeah, Florida, 33013-3835

  • Novo Nordisk Investigational Site

    Huntington Beach, California, 92648

  • Novo Nordisk Investigational Site

    Louisville, Kentucky, 40213

  • Novo Nordisk Investigational Site

    Madisonville, Kentucky, 42431

  • Novo Nordisk Investigational Site

    Meridian, Idaho, 83642

  • Novo Nordisk Investigational Site

    Montclair, California, 91763

  • Novo Nordisk Investigational Site

    Nashville, Tennessee, 37212

  • Novo Nordisk Investigational Site

    New York, New York, 10065

  • Novo Nordisk Investigational Site

    Norfolk, Virginia, 23502

  • Novo Nordisk Investigational Site

    Pembroke Pines, Florida, 33024

  • Novo Nordisk Investigational Site

    Peoria, Arizona, 85381

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania, 19104

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania, 19107

  • Novo Nordisk Investigational Site

    Round Rock, Texas, 78681

  • Novo Nordisk Investigational Site

    Southfield, Michigan, 48034

  • Novo Nordisk Investigational Site

    St Louis, Missouri, 63110

  • Novo Nordisk Investigational Site

    Wilmington, North Carolina, 28401

  • Novo Nordisk Investigational Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada10 sites

  • Novo Nordisk Investigational Site

    Burlington, Ontario, L7M 4Y1

  • Novo Nordisk Investigational Site

    Hamilton, Ontario, L8L 5G8

  • Novo Nordisk Investigational Site

    Laval, Quebec, H7T 2P5

  • Novo Nordisk Investigational Site

    London, N5Y 5K7

  • Novo Nordisk Investigational Site

    Mirabel, Quebec, J7J 2K8

  • Novo Nordisk Investigational Site

    Montreal, H2W 1R7

  • Novo Nordisk Investigational Site

    Sarnia, Ontario, N7T 4X3

  • Novo Nordisk Investigational Site

    Sherbrooke, Quebec, J1H 4J6

  • Novo Nordisk Investigational Site

    Trois-Rivières, Quebec, G8T 7A1

  • Novo Nordisk Investigational Site

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

About this study

Official title: Effect of Liraglutide on Long-term Weight Maintenance and Additional Weight Loss Induced by a 4 to 12 Week Low Calorie Diet in Obese Subjects; A 56 Week Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Trial With a 12 Week Follow-up Period

This trial is conducted in North America. The aim of this clinical trial is to evaluate the potential of liraglutide to maintain long term weight loss in obese non-diabetic subjects, as well as in overweight subjects who have medical problems such as hypertension (high blood pressure) or dyslipidaemia (an abnormal amount of lipids in the blood).

Trial has following trial periods: A 12-week run-in period (from week -12 to week 0) followed by a 56-week main trial period (weeks 0-56) and a 12-week follow-up period (weeks 56-68).

Being tested
liraglutide, placebo
Medical subject headings
Nutrition Disorders, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • liraglutideDrug

    Liraglutide 3.0 mg per day administered in a 6.0 mg/mL, 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily

  • placeboDrug

    Liraglutide placebo 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily

Study groups in NCT00781937
Study groupRoleWhat they receive
Lira 3.0 mgExperimentalA 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
Receives: Drug: liraglutide
PlaceboPlacebo comparatorA 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Percentage Change in Fasting Body Weight From Baseline

    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

    Measured: Week 0, week 56

  2. Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0

    Subjects who had a weight regain less than or equal to 0.5% of weight from Week 0 were regarded as maintenance of run-in fasting weight loss. Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

    Measured: Week 0, week 56

  3. Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0

    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

    Measured: Week 0, week 56

Secondary outcomes (23)

  1. Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0

    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

    Measured: Week 0, week 56

  2. Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 0

    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

    Measured: Week 0, week 56

  3. Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 0

    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

    Measured: Week 0, week 56

  4. Percentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 0

    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

    Measured: Week 0, week 56

  5. Percentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 0

    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

    Measured: Week 0, week 56

  6. Change From Baseline in Fasting Weight

    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

    Measured: Week 0, week 56

  7. Change From Baseline in Fasting Weight for Subjects Completing the Main Trial Period and Entering the Follow-up Period

    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

    Measured: Week 0, week 68

  8. Change From Baseline in Blood Pressure

    Measured: Week 0, week 56

  9. Change From Baseline in Pulse

    Measured: Week 0, week 56

  10. Change From Baseline in Fasting Lipid Profile: Triglycerides

    Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

    Measured: Week 0, week 56

  11. Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol

    Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

    Measured: Week 0, week 56

  12. Change From Baseline in Fasting Lipid Profile: Total Cholesterol

    Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

    Measured: Week 0, week 56

  13. Change From Baseline in Cardiovascular Biomarker: High Sensitivity C-reactive Protein (hsCRP)

    Measured: Week 0, week 56

  14. Percentage of Subjects Meeting Metabolic Syndrome Criteria: ATP (Adult Treatment Panel) III at Week 56

    Metabolic syndrome status required at least 3 of 5 criteria met: Waist circumference (men ≥102cm, women ≥88cm); Triglycerides >1.7mmol/L; High density lipoprotein cholesterol (men <0.9mmol/L, women <1.1mmol/L) or on drug therapy; Blood pressure ≥130mmHg systolic or ≥85mmHg diastolic or on drug therapy; Fasting glucose ≥5.5mmol/L or on drug therapy.

    Measured: Week 56

  15. Change From Baseline in Waist Circumference

    Measured: Week 0, week 56

  16. Change From Baseline in Body Mass Index (BMI)

    Measured: Week 0, week 56

  17. Change From Baseline in Glycaemic Control Parameter: HOMA-B (Homeostasis Model Assessment - Beta Cell Function)

    Change in beta-cell function percent values from Week 0 (X%) to Week 56 (Y%) was calculated [X% - Y%]. Beta-cell function was derived from fasting plasma glucose readings in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged <35 years have median beta-cell function indexed at 100%.

    Measured: Week 0, week 56

  18. Change From Baseline in Glycaemic Control Parameter: HOMA-IR (Homeostasis Model Assessment - Insulin Resistance)

    Change in insulin resistance values from Week 0 (X) to Week 56 (Y) was calculated [X - Y]. Insulin resistance was derived from fasting serum insulin levels in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged <35 years have median insulin resistance indexed at 1.00.

    Measured: Week 0, week 56

  19. Change From Baseline in Glycaemic Control Parameter: Fasting Plasma Glucose (FPG)

    Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

    Measured: Week 0, week 56

  20. Change From Baseline in Glycaemic Control Parameter: Fasting Serum Insulin

    Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

    Measured: Week 0, week 56

  21. Change From Baseline in Glycaemic Control Parameter: HbA1c (Glycosylated Haemoglobin)

    Change in HbA1c percent values from Week 0 (X%) to Week 56 (Y%) was calculated [X% - Y%].

    Measured: Week 0, week 56

  22. Number of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications)

    Number of subjects using concomitant medications at Week 0 and Week 56, respectively

    Measured: Week 0 and week 56

  23. Binge Eating Scale Scores by Week and Severity

    Binge Eating Scale (BES) scores are based on responses to the Binge Eating Scale Questionnaire, a 16-item self-reporting diagnostic tool scaled 0-46 (Non-binging: 0-17; Moderate: 17-26; Severe: 27-46)

    Measured: Week 0, week 50 and week 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2008 (estimated)
  2. Study start30 Oct 2008
  3. Primary completion1 Sep 2010
  4. Study completion1 Sep 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
422 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00781937
Sponsor's protocol ID
NN8022-1923
Status last verified
Sep 2017
First submitted
28 Oct 2008
Last updated
1 Nov 2017
Data monitoring committee
No

Publications

  • O'Neil PM, Garvey WT, Gonzalez-Campoy JM, Mora P, Ortiz RV, Guerrero G, Claudius B, Pi-Sunyer X; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. EFFECTS OF LIRAGLUTIDE 3.0 MG ON WEIGHT AND RISK FACTORS IN HISPANIC VERSUS NON-HIPANIC POPULATIONS: SUBGROUP ANALYSIS FROM SCALE RANDOMIZED TRIALS. Endocr Pract. 2016 Nov;22(11):1277-1287. doi: 10.4158/EP151181.OR. Epub 2016 Aug 2.

    PubMed 27482610

  • Bays H, Pi-Sunyer X, Hemmingsson JU, Claudius B, Jensen CB, Van Gaal L. Liraglutide 3.0 mg for weight management: weight-loss dependent and independent effects. Curr Med Res Opin. 2017 Feb;33(2):225-229. doi: 10.1080/03007995.2016.1251892. Epub 2016 Nov 6.

    PubMed 27817208

  • Wadden TA, Hollander P, Klein S, Niswender K, Woo V, Hale PM, Aronne L; NN8022-1923 Investigators. Weight maintenance and additional weight loss with liraglutide after low-calorie-diet-induced weight loss: the SCALE Maintenance randomized study. Int J Obes (Lond). 2013 Nov;37(11):1443-51. doi: 10.1038/ijo.2013.120. Epub 2013 Jul 1.

    PubMed 23812094

  • McEvoy BW. Missing data in clinical trials for weight management. J Biopharm Stat. 2016;26(1):30-6. doi: 10.1080/10543406.2015.1094814.

    PubMed 26418188

  • Steinberg WM, Rosenstock J, Wadden TA, Donsmark M, Jensen CB, DeVries JH. Impact of Liraglutide on Amylase, Lipase, and Acute Pancreatitis in Participants With Overweight/Obesity and Normoglycemia, Prediabetes, or Type 2 Diabetes: Secondary Analyses of Pooled Data From the SCALE Clinical Development Program. Diabetes Care. 2017 Jul;40(7):839-848. doi: 10.2337/dc16-2684. Epub 2017 May 4.

    PubMed 28473337

  • O'Neil PM, Aroda VR, Astrup A, Kushner R, Lau DCW, Wadden TA, Brett J, Cancino AP, Wilding JPH; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials. Diabetes Obes Metab. 2017 Nov;19(11):1529-1536. doi: 10.1111/dom.12963. Epub 2017 Jul 21.

    PubMed 28386912

  • Davies MJ, Aronne LJ, Caterson ID, Thomsen AB, Jacobsen PB, Marso SP; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials. Diabetes Obes Metab. 2018 Mar;20(3):734-739. doi: 10.1111/dom.13125. Epub 2017 Nov 1.

    PubMed 28950422

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing liraglutide in people with Metabolism and Nutrition Disorder and Obesity, run by Novo Nordisk A/S at 37 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Percentage Change in Fasting Body Weight From Baseline (time frame: Week 0, week 56). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00781937, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.

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