Efficacy of Liraglutide for Weight Loss Among Patients With Type 2 Diabetes: The SCALE Diabetes Randomized Clinical Trial
Open accessAbstract
IMPORTANCE: Weight loss of 5% to 10% can improve type 2 diabetes and related comorbidities. Few safe, effective weight-management drugs are currently available. OBJECTIVE: To investigate efficacy and safety of liraglutide vs placebo for weight management in adults with overweight or obesity and type 2 diabetes. DESIGN, SETTING, AND PARTICIPANTS: Fifty-six-week randomized (2:1:1), double-blind, placebo-controlled, parallel-group trial with 12-week observational off-drug follow-up period. The study was conducted at 126 sites in 9 countries between June 2011 and January 2013. Of 1361 participants assessed for eligibility, 846 were randomized. Inclusion criteria were body mass index of 27.0 or greater, age 18 years or older, taking 0 to 3 oral hypoglycemic agents (metformin, thiazolidinedione, sulfonylurea) with stable body weight, and glycated hemoglobin level 7.0% to 10.0%. INTERVENTIONS: Once-daily, subcutaneous liraglutide (3.0 mg) (n = 423), liraglutide (1.8 mg) (n = 211), or placebo (n = 212), all as adjunct to 500 kcal/d dietary deficit and increased physical activity (≥150 min/wk). MAIN OUTCOMES AND MEASURES: Three coprimary end points: relative change in weight, proportion of participants losing 5% or more, or more than 10%, of baseline weight at week 56. RESULTS: Baseline weight was 105.7 kg with liraglutide (3.0-mg dose), 105.8 kg with liraglutide (1.8-mg dose), and 106.5 kg with placebo. Weight loss was 6.0% (6.4 kg) with liraglutide (3.0-mg dose), 4.7% (5.0 kg) with liraglutide (1.8-mg dose), and 2.0% (2.2 kg) with placebo (estimated difference for liraglutide [3.0 mg] vs placebo, -4.00% [95% CI, -5.10% to -2.90%]; liraglutide [1.8 mg] vs placebo, -2.71% [95% CI, -4.00% to -1.42%]; P < .001 for both). Weight loss of 5% or greater occurred in 54.3% with liraglutide (3.0 mg) and 40.4% with liraglutide (1.8 mg) vs 21.4% with placebo (estimated difference for liraglutide [3.0 mg] vs placebo, 32.9% [95% CI, 24.6% to 41.2%]; for liraglutide [1.8 mg] vs placebo, 19.0% [95% CI, 9.1% to 28.8%]; P < .001 for both). Weight loss greater than 10% occurred in 25.2% with liraglutide (3.0 mg) and 15.9% with liraglutide (1.8 mg) vs 6.7% with placebo (estimated difference for liraglutide [3.0 mg] vs placebo, 18.5% [95% CI, 12.7% to 24.4%], P < .001; for liraglutide [1.8 mg] vs placebo, 9.3% [95% CI, 2.7% to 15.8%], P = .006). More gastrointestinal disorders were reported with liraglutide (3.0 mg) vs liraglutide (1.8 mg) and placebo. No pancreatitis was reported. CONCLUSIONS AND RELEVANCE: Among overweight and obese participants with type 2 diabetes, use of subcutaneous liraglutide (3.0 mg) daily, compared with placebo, resulted in weight loss over 56 weeks. Further studies are needed to evaluate longer-term efficacy and safety. TRIAL REGISTRATION: clinicaltrials.gov Identifier:NCT01272232.
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Adding weight-loss medications produces significantly more weight loss than lifestyle intervention alone and yields greater A1C lowering and improvements in cardiometabolic risk factors.
“The addition of weight-loss medications has been shown to achieve significantly more weight loss than lifestyle interventions alone and produce greater A1C lowering and improvements in cardiometabolic risk factors.”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [737]
The Primary End Points section reports significantly greater weight loss with liraglutide than placebo; all groups also received dietary and physical-activity intervention. Table 3 and the Secondary Efficacy End Points section report greater A1C lowering and improvements in some cardiometabolic measures. The claim generalizes these findings from liraglutide in adults with type 2 diabetes to weight-loss medications broadly. (LLM, conf=0.86)
Experimental — accuracy not yet measuredAll FDA-approved medications for chronic weight management have been shown to be effective and safe in people with type 2 diabetes in randomized controlled trials and a meta-analysis.
“All FDAdapproved medications for chronic weight management have also been demonstrated to be effective and safe in both RCTs and a meta-analysis involving persons with T2D.735–742”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [737]
The Discussion (page unavailable in our copy) reports that a randomized trial found liraglutide 3.0 mg effective and generally well tolerated for weight management in participants with type 2 diabetes. This paper does not establish the claim for all FDA-approved chronic weight-management medications or report a meta-analysis; its Conclusions also call for further study of longer-term safety. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn studies of weight-loss medications in type 2 diabetes, medication arms consistently produced greater weight loss than lifestyle alone, lower A1C despite less need for diabetes medications, reductions in blood pressure, lower triglycerides and higher HDL-C, decreased hepatic transaminases, and improvements in inflammatory and other biomarkers such as CRP, fibrinogen, and adiponectin, compared to
“The study’s weight-loss medication arms consistently resulted in: (1) greater weight loss than lifestyle alone, (2) lower A1C values despite less need for DM medications, (3) reductions in BP, (4) lower triglycerides and higher HDL-C, (5) decreased levels of hepatic transaminases, and (6) improvements in inflammatory and other biomarkers such as CRP, fibrinogen, and adiponectin, when compared to”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [737]
The Secondary Efficacy End Points section reports greater reductions in HbA1c and oral hypoglycemic-agent use, lower systolic blood pressure, and improved CRP with liraglutide versus placebo; the 3.0-mg dose also improved triglycerides and HDL-C. But it reports increased fibrinogen, no effect on adiponectin, and lipid improvements only at the 3.0-mg dose. The passages found do not establish a reduction in hepatic transaminases. (LLM, conf=0.90)
Experimental — accuracy not yet measuredMore episodes of gallstone disease occurred with liraglutide, a finding that has been reported previously.
“There were more episodes of gallstone disease with liraglutide, a finding that has been reported previously.”
From Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes (2016) · cites this paper as [26]
The Safety section reports more gallbladder-related adverse events with liraglutide than placebo (1.2% and 1.9% versus 0.5%). It does not identify those events specifically as gallstone disease or say that this particular finding had been reported previously. (LLM, conf=0.82)
Experimental — accuracy not yet measuredDavies et al. observed that in obese patients with T2D treated with varying doses of Liraglutide, after 12 weeks, average weight loss was 4.7% (−5 kg) and increased to 6% (−6.4 kg) when doses rose from 1.8 to 3 mg, compared to about 2.2% (−2.2 kg) among those on placebo.
“after following this regimen for 12 weeks, average weight loss stood at 4.7% of initial body mass (−5 kg as an absolute value) and increased to 6% (−6.4 kg as an absolute value) when administered doses rose from 1.8 to 3 mg respectively, compared against a mere loss of about 2.2% body mass (which equates to −2.2 kg actual value) among those on placebo.”
From Anti-inflammatory role of glucagon-like peptide 1 receptor agonists and its clinical implications (2024) · cites this paper as [89]
The Abstract and Primary End Points (Body Weight) report weight losses of 4.7% (5.0 kg) at 1.8 mg and 6.0% (6.4 kg) at 3.0 mg, but these are week-56 outcomes, not results after 12 weeks. They report placebo weight loss as 2.0% (2.2 kg), not 2.2%; the Abstract describes the 12 weeks as an off-drug follow-up period. (LLM, conf=0.90)
Experimental — accuracy not yet measured
Most patients taking a GLP-1 receptor agonist achieve clinically meaningful weight loss.
“Although most patients taking a GLP-1 RA achieve clinically meaningful weight loss, heterogeneity in response exists.3,4,5,6,7,12”
From Discontinuation and Reinitiation of Dual-Labeled GLP-1 Receptor Agonists Among US Adults With Overweight or Obesity (2025) · cites this paper as [7]
Table 2 (section labeled Conclusions; page unavailable) reports that an estimated 54.3% of participants receiving liraglutide 3.0 mg lost at least 5% of body weight at week 56, but only 40.4% receiving 1.8 mg did. The trial studied liraglutide in adults with overweight or obesity and type 2 diabetes; it does not establish that most patients taking GLP-1 receptor agonists generally achieve clinically meaningful weight loss. (LLM, conf=0.86)
Experimental — accuracy not yet measuredOf currently available agents, tirzepatide and semaglutide have the highest efficacy in terms of glucose lowering as well as weight loss, followed by dulaglutide, liraglutide, and extended-release exenatide.
“Of the currently available agents, tirzepatide and semaglutide have the highest efficacy in terms of glucose lowering as well as weight loss, followed by dulaglutide, liraglutide, and extendedrelease exenatide (157-161).”
From 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025 (2025) · cites this paper as [160]
The Results and Discussion (page not supplied) show that liraglutide reduced weight and improved glycemic measures in adults with type 2 diabetes compared with placebo. This trial does not establish the claimed efficacy ranking among tirzepatide, semaglutide, dulaglutide, liraglutide, and extended-release exenatide. (LLM, conf=0.88)
Experimental — accuracy not yet measuredLiraglutide 3.0 mg reduces weight and HbA1c in type 2 diabetes.
“Liraglutide 3.0 mg achieved ~ 6.0% Weight loss and 1.3% Hba1c reductions in the SCALE Diabetes trial [33].”
From Precision obesity medicine: A phenotype-guided framework for pharmacologic therapy across the lifespan (2025) · cites this paper as [33]
GLP-1 receptor agonists substantially lower weight, hemoglobin A1c levels, and cardiovascular risk.
“Although glucagon-like peptide-1 receptor agonists (GLP-1 RAs) substantially lower weight,3,4,5,6,7 hemoglobin A1c levels, and cardiovascular risk,8 trials suggest they must be continued for sustained effects.9,10”
From Discontinuation and Reinitiation of Dual-Labeled GLP-1 Receptor Agonists Among US Adults With Overweight or Obesity (2025) · cites this paper as [7]
More than 70% of patients in clinical trials of GLP-1 receptor agonists reported adverse events, most often gastrointestinal, that were mild.
“More than 70% of patients in clinical trials of GLP-1 RAs reported adverse events, most often gastrointestinal (GI), that were mild.3,4,5,6,7”
From Discontinuation and Reinitiation of Dual-Labeled GLP-1 Receptor Agonists Among US Adults With Overweight or Obesity (2025) · cites this paper as [7]
Heterogeneity in response to GLP-1 receptor agonist weight loss exists.
“Although most patients taking a GLP-1 RA achieve clinically meaningful weight loss, heterogeneity in response exists.3,4,5,6,7,12”
From Discontinuation and Reinitiation of Dual-Labeled GLP-1 Receptor Agonists Among US Adults With Overweight or Obesity (2025) · cites this paper as [7]
Orlistat has been shown to be effective in people with type 2 diabetes.
“and has been shown to be effective in those with T2D.735–737,739”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [737]
The Discussion mentions orlistat only in connection with weight regain after treatment stops; it does not address orlistat’s effectiveness in people with type 2 diabetes. The Abstract and Discussion report efficacy for liraglutide in that population, not orlistat (searched: orlistat). (LLM, conf=0.77)
Experimental — accuracy not yet measuredIn the SCALE trial, a decreased urinary albumin/creatinine ratio was observed in both liraglutide arms compared with placebo.
“At the end of the 56-week study period, a significant weight loss also but a decreased urinary albumin/creatinine ratio (UACR) was observed in both liraglutide arms compared with placebo (18.36, 10.79 and 2.34%, respectively).”
From GLP-1 receptor agonists and renal outcomes in patients with diabetes mellitus type 2 and diabetic kidney disease: state of the art (2022) · cites this paper as [43]
In the SCALE Diabetes and SCALE Insulin trials, liraglutide's mean weight-loss difference versus placebo was below 5% after one year, but 51.8% to 54.3% of liraglutide-treated participants lost at least 5% of baseline body weight.
“In both trials the difference in mean weight loss between the liraglutide and placebo-treated groups was < 5% after 1 year of treatment, but the proportion of subjects who lost ≥ 5% of baseline body weight in the liraglutide group was > 35%, from 51.8 to 54.3% [20, 21].”
From Efficacy of GLP-1 RA Approved for Weight Management in Patients With or Without Diabetes: A Narrative Review (2022) · cites this paper as [20]
In patients with diabetes, weight loss of at least 15% was achieved almost exclusively by those receiving liraglutide or semaglutide, not by those receiving placebo.
“While some patients with diabetes achieved ≥ 5 or 10% with placebo, higher levels of ≥ 15% in patients with diabetes were achieved almost exclusively with those who received liraglutide or semaglutide and not by those on placebo [20–22].”
From Efficacy of GLP-1 RA Approved for Weight Management in Patients With or Without Diabetes: A Narrative Review (2022) · cites this paper as [20]
In patients with diabetes, semaglutide met both FDA efficacy benchmark criteria, whereas liraglutide did not meet the mean-difference criterion versus placebo.
“In patients with diabetes, both efficacy benchmarks were achieved by semaglutide [22], while the efficacy of liraglutide did not meet the criteria in mean difference between active product vs. placebo [20, 21].”
From Efficacy of GLP-1 RA Approved for Weight Management in Patients With or Without Diabetes: A Narrative Review (2022) · cites this paper as [20]
Non-diabetic patients demonstrated greater weight loss (−8.5%) compared to diabetic patients (−4.87%).
“Notably, non‐diabetic patients demonstrated greater weight loss (−8.5%) compared to diabetic patients (−4.87%), a finding consistent with previous GLP‐1 agonist studies [29, 30, 31, 32].”
From Efficacy and Safety of Orforglipron in Obese Adults With or Without Diabetes: A Systematic Review and Meta‐Analysis (2025) · cites this paper as [30]
Naltrexone plus bupropion extended-release reduces weight on average by about 7% (about 5% placebo-subtracted) and more than either agent alone.
“Naltrexone plus bupropion extended-release reduces weight on average by ≈7% (≈5% placebo-subtracted) [51][52][53][54] and also more than either agent administered alone.55”
From Approach to Obesity Treatment in Primary Care: A Review (2024) · cites this paper as [55]
A 56-week intervention with liraglutide 3 mg/day as an adjunct to lifestyle modification resulted in significant weight loss compared with placebo in the SCALE trials.
“a 56-week intervention with liraglutide 3 mg/day as an adjunct to lifestyle modification resulted in significant weight loss compared with placebo [41, 42].”
From GLP-1 Receptor Agonists for Obesity Management in Older Adults: A Scoping Review on the Risk of Sarcopenia and Sarcopenic Obesity (2026) · cites this paper as [42]
Less weight loss in people with type 2 diabetes than in those without has also been seen with other anti-obesity drugs-orlistat, naltrexone-bupropion, and liraglutide 3.0 mg-and with some behavioral programs.
“Similar attenuation in weight loss in patients with vs without type 2 diabetes has been observed with other AOM, including orlistat,(44) naltrexone-bupropion,(45) and liraglutide 3.0 mg,(46) as well as with some behavioral interventions.(47, 48)”
From Semaglutide for the treatment of obesity (2023) · cites this paper as [46]
In the SCALE diabetes study, patients with type 2 diabetes randomized to liraglutide 3.0 mg lost 6.0% total body weight versus 2.0% with placebo after 56 weeks.
“In the SCALE diabetes study, a total body weight loss of 6.0% was seen in patients with T2D randomized to liraglutide (3.0 mg, daily subcutaneous injection) versus 2.0% with placebo after 56 weeks of treatment [30].”
The amount of weight lost with GLP1-RA in this real-world group matches the results of the SCALE, SUSTAIN, and STEP trials.
“The magnitude of weight loss observed with GLP1-RA in this real-life patient population is consistent with findings from the SCALE, SUSTAIN, and STEP clinical trials, which are based on patients without bariatric surgery.”
The present study includes patients with type 2 diabetes, who have been shown to lose less weight with GLP1-RA therapy.
“The current study includes patients with T2D that have been shown to lose less weight with GLP1-RA therapy [29, 30, 32, 33]”
Previous studies have shown that GLP1-RAs tend to induce less weight loss in patients with type 2 diabetes than in those without.
“previous studies have shown that GLP1-RAs tend to induce less weight loss in patients with than without T2D [29, 30, 32, 33]”
Intention-to-treat 1-year placebo-subtracted weight reduction with liraglutide 3.0 mg was 5.2%, 4%, 3.4%, and 6.1% for SCALE, SCALE Diabetes, SCALE IBT, and SCALE Maintenance, respectively.
“Intention-to-treat 1-year placebo-subtracted weight reduction was 5.2%, 4%, 3.4%, and 6.1% for SCALE, SCALE Diabetes, SCALE IBT, and SCALE Maintenance, respectively.”
From New Frontiers in Obesity Treatment: GLP-1 and Nascent Nutrient-Stimulated Hormone-Based Therapeutics (2023) · cites this paper as [25]
Liraglutide significantly improved treatment satisfaction vs placebo (DTSQ) (p=0.007 for 3 mg dose group).
“Liraglutide also significantly improved treatment satisfaction vs. placebo (Diabetes Treatment Satisfaction Questionnaire) [42] (p = 0.007 for the 3 mg dose group).”
From Symptomatic Adverse Events and Quality of Life Related to Incretin-Based Medicines for Obesity: A Systematic Review Involving >400,000 Subjects (2025) · cites this paper as [42]
The proportion of patients experiencing nausea then gradually decreased up to the end of the trial period.
“The proportion of patients experiencing nausea then gradually decreased up to the end of the trial period [42,67,81,95].”
From Symptomatic Adverse Events and Quality of Life Related to Incretin-Based Medicines for Obesity: A Systematic Review Involving >400,000 Subjects (2025) · cites this paper as [42]
In the SCALE clinical studies (liraglutide), most AEs were mild or moderate in severity, and occurred primarily within the first four to eight weeks of treatment (during dose escalation).
“In the SCALE clinical studies (liraglutide), most AEs were mild or moderate in severity, and occurred primarily within the first four to eight weeks of treatment (during dose escalation).”
From Symptomatic Adverse Events and Quality of Life Related to Incretin-Based Medicines for Obesity: A Systematic Review Involving >400,000 Subjects (2025) · cites this paper as [42]
Based on a single study, treatment satisfaction with IBTs was high.
“Based on a single study, treatment satisfaction with IBTs was high [42].”
From Symptomatic Adverse Events and Quality of Life Related to Incretin-Based Medicines for Obesity: A Systematic Review Involving >400,000 Subjects (2025) · cites this paper as [42]
The SCALE trials reported similar but slightly more pronounced weight loss ranging from 5.7% to 8%.
“the data from SCALE trials reported similar but slightly pronounced weight loss ranging from 5.7% to 8% (31, 32, 33).”
From Effects of liraglutide on obesity-associated functional hypogonadism in men (2019) · cites this paper as [32]
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Chiang, C.-H., Jaroenlapnopparat, A., Colak, S. C., Yu, C.-C., Xanthavanij, N., Wang, T.-H., See, X. Y., Lo, S.-W., Ko, A., Chang, Y.-C., et al. (2025) · Gastroenterology · doi:10.1053/j.gastro.2025.06.003 · Cited by 105 · see citing works
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- Authors
- Davies, M. J., Bergenstal, R., Bode, B., Kushner, R. F., Lewin, A., Skjøth, T. V., Andreasen, A. H., Jensen, C. B., DeFronzo, R. A., & for the NN8022-1922 Study Group
- Affiliations
- University of Leicester (GB)
- Park Nicollet Health Services (US)
- Atlanta Diabetes Associates (US)
- Northwestern University (US)
- National Research Institute (US)
- Novo Nordisk (Denmark) (DK)
- Texas Diabetes Institute (US)
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2015-08-18
- Volume
- 314
- Issue
- 7
- Pages
- 687
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W1798757189
- Cited by
- 1,198
- References
- 29
- Citations by year
- 2026: 121 · 2025: 188 · 2024: 152 · 2023: 141 · 2022: 94 · 2021: 114 · 2020: 74 · 2019: 67 · 2018: 78 · 2017: 74 · 2016: 83 · 2015: 11
- FWCI
- 59.16
- Type
- journal article
- Language
- en
- Open access
- green
- jama.jamanetwork.com
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- Leicester Research Archive (University of Leicester) (acceptedVersion)
- Figshare (submittedVersion, cc-by)
- Funders
- Amgen
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Gilead Sciences
- Leona M. and Harry B. Helmsley Charitable Trust
- MannKind Corporation
- Halozyme
- Dexcom
- Zafgen
- ResMed
- Bayer HealthCare
- Novo Nordisk
- Servier
- Bavarian Nordic
- Esperion Therapeutics
- National Institutes of Health
- Abbott Diabetes Care
- Topics
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Keywords
- liraglutide, type 2 diabetes, weight loss, obesity, overweight, GLP-1 receptor agonists, physical activity, HbA1c, glycemic control, drug safety, adverse events, dose comparison, weight regain, body mass index
- MeSH terms
- Liraglutide, Adult, Aged, Body Weight, Diabetes Mellitus, Type 2, Diet, Reducing, Double-Blind Method, Female, Humans, Hypoglycemic Agents, Injections, Subcutaneous, Male, Middle Aged, Obesity, Weight Loss, Exercise, Glucagon-Like Peptide 1
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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