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Orforglipron-Obesity
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling.
In ATTAIN-1, how did orforglipron compare with placebo in adults with obesity or overweight with weight-related comorbidities?
In ATTAIN-1, orforglipron reduced body weight by 7.5% to 11.2% at 72 weeks, compared with 2.1% with placebo (treatment-regimen estimand). The safety and tolerability of orforglipron were consistent with injectable GLP-1 RAs.
Content Overview
ATTAIN-1 Overview
ATTAIN-1 was a phase 3, 72-week, double-blind, randomized, placebo-controlled trial comparing the efficacy and safety of orforglipron 6 mg, 12 mg, and 36 mg as monotherapy to placebo as an adjunct to healthy diet and physical activity in adults with obesity without diabetes mellitus.1
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Study Design in ATTAIN-1
The ATTAIN-1 trial randomized 3127 participants across the United States (including Puerto Rico), Brazil, China, India, Japan, Republic of Korea, Slovakia, Spain, and Taiwan in a 3:3:3:4 ratio to receive either
- orforglipron 6 mg
- orforglipron 12 mg
- orforglipron 36 mg, or
- placebo.1
During the study, orforglipron was administered daily by oral capsule without food and water restrictions.1
ATTAIN-1 Study Design Overview presents an overview of the study design, including the different treatment arms and dose escalation strategy for orforglipron.
Figure 1 description: ATTAIN-1 was a phase 3, 72-week, double-blind, placebo-controlled trial that randomized 3127 adults with obesity or overweight with at least one weight-related comorbidity in a 3:3:3:4 ratio to receive orforglipron (6 mg, 12 mg, or 36 mg) or placebo once daily. Orforglipron-treated participants followed a dose escalation regimen (starting at 1 mg, followed by 3 mg, 6 mg, 12 mg, 24 mg, and 36 mg) every 4 weeks until the assigned dose was reached. Dose reduction was allowed if gastrointestinal symptoms persisted despite mitigations. All participants received personalized counselling throughout the study, focused on a healthy, balanced diet along with physical activity.
Abbreviations: OFG = orforglipron; PBO = placebo; QD = once daily.
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Key Inclusion and Exclusion Criteria in ATTAIN-1
Key inclusion and exclusion criteria for the ATTAIN-1 study are presented in Key Inclusion and Exclusion Criteria in ATTAIN-1.
Key Inclusion Criteria |
Key Exclusion Criteria |
|
|
Abbreviations: BMI = body mass index; MEN2 = multiple endocrine neoplasia syndrome type 2; MTC = medullary thyroid cancer; T1D = type 1 diabetes; T2D = type 2 diabetes.
aFor example, ischemic cardiovascular disease or New York Heart Association Functional Class I-III heart failure.
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Key Primary and Secondary Endpoints in ATTAIN-1
The primary objective in ATTAIN-1 was to demonstrate that orforglipron (6 mg, 12 mg, 36 mg) is superior to placebo in percent change in body weight from baseline to week 72.1
Key multiplicity-adjusted secondary endpoints measured at week 72 included the
- percent of participants with body weight reduction ≥5%, ≥10%, ≥15%, and ≥20%, and
- change from baseline in waist circumference, systolic blood pressure (SBP), non-high-density lipoprotein (non-HDL) cholesterol, and triglycerides.1
A graphical testing procedure for multiple comparisons was used for testing the primary and multiplicity-adjusted secondary end points to control for the overall family-wise type I error rate at 0.05.1
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Baseline Demographics and Clinical Characteristics of Participants in ATTAIN-1
In the ATTAIN-1 study, baseline demographics and clinical characteristics of participants were consistent across all treatment groups. At baseline, participants had a mean
- age of 45 years
- body weight of 103.2 kg, and
- body mass index (BMI) of 37.0 kg/m2.1
In the overall study population, 64.2% of participants were female.1
At baseline, the mean glycated hemoglobin (HbA1c) was 5.6% and 36.0% of participants had prediabetes.1
More information on baseline demographics and clinical characteristics in the ATTAIN-1 study can be found in the Appendix .
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Discontinuation
A total of 2662 (85.1%) participants completed the ATTAIN-1 trial, and 2344 (75.0%) participants continued to receive study treatment throughout the 72-week treatment period.1
Efficacy Results From ATTAIN-1
Efficacy Estimand and Treatment Regimen Estimand
Two statistical estimands, efficacy or treatment-regimen, were used to evaluate efficacy data in ATTAIN-1. Briefly, the
- efficacy estimand represents treatment effect as if all randomized participants remained on study intervention (with possible dose interruptions and modifications) for 72 weeks without initiating prohibited weight management treatments, and
- treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation of study intervention or initiation of prohibited weight management treatments.1
The treatment-regimen estimand was the primary estimand, with the efficacy estimand considered supportive. There was no adjustment for multiple comparisons between estimands, nor for any other analyses beyond the primary and key secondary objectives.1
Back to Content Overview .
Primary and Secondary Endpoint Results From ATTAIN-1
In ATTAIN-1, treatment with orforglipron met the primary endpoint of superior body weight reduction compared with placebo.1
At week 72, for the treatment-regimen estimand, mean percent change from baseline in body weight was
- -7.5% with orforglipron 6 mg
- -8.4% with orforglipron 12 mg
- -11.2% with orforglipron 36 mg, and
- -2.1% with placebo (p<.001 for all orforglipron doses vs placebo; Treatment-Regimen and Efficacy Estimand for Efficacy Endpoints in ATTAIN-1).1
Change in body weight over time in ATTAIN-1 is presented in Change From Baseline in Body Weight Over Time in ATTAIN-1.
Figure 2 description: In ATTAIN-1, change from baseline in body weight at week 72 was -7.8%, -9.3%, and -12.4% with orforglipron 6 mg, 12 mg, and 36 mg, respectively, and -0.9% with placebo.
Notes: Data are presented as model-based estimates (95% CI), along with ETD (95% CI) between orforglipron groups and placebo based on MMRM analysis (efficacy estimand).
Abbreviations: ETD = estimated treatment difference; MMRM = mixed model for repeated measures; OFG = orforglipron; PBO = placebo.
For the treatment-regimen estimand, significantly more participants treated with orforglipron had body weight reduction ≥5%, ≥10%, ≥15%, and 20% at week 72 when compared with placebo (p<.001 for all orforglipron doses vs placebo) as presented in Treatment-Regimen and Efficacy Estimand for Efficacy Endpoints in ATTAIN-1.1
Additionally, as described in Treatment-Regimen and Efficacy Estimand for Secondary Cardiometabolic Risk Factor Efficacy Endpoints in ATTAIN-1, for the treatment-regimen estimand at week 72, significant improvements were observed for the key secondary cardiometabolic risk factor endpoints, which included
- waist circumference (p<.001 for all orforglipron doses vs placebo), and
- SBP, non-HDL cholesterol, and triglycerides (p<.001 for the pooled orforglipron group vs placebo for each endpoint).1
Refer to Treatment-Regimen and Efficacy Estimand for Efficacy Endpoints in ATTAIN-1 and Treatment-Regimen and Efficacy Estimand for Secondary Cardiometabolic Risk Factor Efficacy Endpoints in ATTAIN-1 for additional information on the primary and key secondary endpoint efficacy estimand results at week 72.
|
Treatment-Regimen Estimand |
Efficacy Estimand |
||||||
Parametera |
Orforglipron 6 mg (N=723) |
Orforglipron 12 mg (N=725) |
Orforglipron 36 mg (N=730) |
Placebo (N=949) |
Orforglipron 6 mg (N=723) |
Orforglipron 12 mg (N=725) |
Orforglipron 36 mg (N=730) |
Placebo (N=949) |
Primary endpoint |
||||||||
Change in body weight from baseline to week 72, % |
-7.5 |
-8.4 |
-11.2 |
-2.1 |
-7.8 |
-9.3 |
-12.4 |
-0.9 |
Difference vs. placebo, % |
-5.5 |
-6.3 (-7.3, -5.4)* |
-9.1 (-10.1, -8.1)* |
NA |
-6.9 (-7.7, -6.2) |
-8.4 (-9.3, -7.6) |
-11.5 (-12.3, -10.6) |
NA |
Key secondary endpoints |
||||||||
Proportion of participants with weight reduction threshold at week 72, % |
||||||||
≥5% |
60.6* |
63.5* |
71.8* |
26.8 |
63.8 |
69.3 |
77.1 |
22.1 |
≥10% |
33.3* |
40.0* |
54.6* |
12.9 |
35.9 |
45.1 |
59.6 |
8.6 |
≥15% |
15.1* |
20.3* |
36.0* |
5.9 |
16.5 |
24.0 |
39.6 |
3.6 |
≥20% |
6.4* |
9.0* |
18.4* |
2.8 |
7.2 |
11.4 |
20.1 |
1.6 |
Abbreviations: ANCOVA = analysis of covariance; MMRM = mixed model for repeated measures; NA = not applicable.
Notes: *p<.001 (two-sided) for superiority vs placebo, adjusted for multiplicity at week 72.
aData are model-based estimates (95% CI) assessed with the use of ANCOVA (treatment-regimen estimand) or from MMRM (efficacy estimand). The CIs have not been adjusted for multiplicity and should not be used for hypothesis testing. For the proportion of participants with body weight reduction thresholds, data are presented as model-based estimate from logistic regression. Percentages were calculated by combining the percentages of participants who met the target in imputed data sets with the use of Rubin’s rules.
|
Treatment-Regimen Estimand |
Efficacy Estimand |
||||||||
Parametera |
Orforglipron |
Orforglipron |
Orforglipron |
Pooled |
Placebo |
Orforglipron |
Orforglipron |
Orforglipron |
Pooled |
Placebo |
Change in waist circumference, cm |
-7.1* |
-8.2* |
-10.0* |
NA |
-3.1 |
-7.5 |
-9.0 |
-11.1 |
NA |
-2.1 |
Change in SBP, mmHg |
-5.7 |
-5.1 |
-6.3 |
-5.7* |
-1.4 |
-5.8 |
-5.9 |
-6.7 |
-6.1 |
-0.8 |
Change in non-HDL cholesterol, % |
-5.4 |
-7.0 |
-7.7 |
-6.7* |
-1.9 |
-5.9 |
-8.3 |
-8.5 |
-7.6 |
-1.4 |
Change in triglycerides, % |
-10.4 |
-13.5 |
-20.2 |
-14.8* |
-3.8 |
-12.1 |
-15.2 |
-21.6 |
-16.4 |
-4.8 |
Abbreviations: ANCOVA = analysis of covariance; HDL = high-density lipoprotein; MMRM = mixed model for repeated measures; NA = not applicable; SBP = systolic blood pressure.
Notes: *p<.001 (two-sided) for superiority vs placebo, adjusted for multiplicity at week 72.
aData are model-based estimates assessed with the use of ANCOVA (treatment-regimen estimand) or from MMRM (efficacy estimand). Lipid measures were log-transformed before fitting the analysis-of-covariance model, and results were then back-transformed with the delta method from the model-based estimate and standard errors on the natural log scale.
bThe pooled orforglipron group includes patients in the 6 mg, 12 mg, and 36 mg orforglipron groups.
Additional Efficacy Findings From ATTAIN-1
For the treatment-regimen estimand, at week 72, mean decrease in diastolic blood pressure was
- -2.4 mm Hg in the pooled orforglipron group, and
- -1.4 mm Hg in the placebo group.1
Change in total cholesterol at week 72, for the treatment-regimen estimand, was
- -4.1% in the pooled orforglipron group, and
- -2.0% in the placebo group.1
At week 72, using the treatment-regimen estimand, change in high-sensitivity C-reactive protein (hsCRP) was
- -33.3% with orforglipron 6 mg
- -38.6% with orforglipron 12 mg
- -43.6% with orforglipron 36 mg, and
- -14.7% with placebo.1
Additionally, at week 72, the proportion of participants with prediabetes at baseline who had normoglycemic levels was
- 74.6% to 83.7% of orforglipron-treated participants, and
- 44.6% of placebo-treated participants.1
Back to Content Overview .
Changes in Body Composition in ATTAIN-1
In ATTAIN-1, changes in body composition from baseline to week 72 were assessed in a subset of participants using dual-energy X-ray absorptiometry (DXA).1
Refer to Change in Body Composition at Week 72 in Participants Undergoing DXA for information on both the treatment-regimen and efficacy estimand for participants who completed DXA scans, including mean percent change in
- total body fat mass
- lean mass, and
- visceral fat mass.
|
Treatment-Regimen Estimand |
Efficacy Estimand |
||||||
Parametera |
Orforglipron 6 mg |
Orforglipron 12 mg |
Orforglipron 36 mg |
Placebo |
Orforglipron 6 mg |
Orforglipron 12 mg |
Orforglipron 36 mg |
Placebo |
Total fat mass, (%) |
-12.0 |
-9.4 |
-20.0 |
-1.7 |
-14.8 |
-11.1 |
-25.7 |
-1.2 |
Total lean mass, (%) |
-3.7 |
-3.2 |
-6.6 |
0.3 |
-4.9 |
-4.1 |
-8.2 |
0.8 |
Visceral fat mass, (%) |
-16.3 |
-12.6 |
-28.2 |
7.4 |
-20.3 |
-16.0 |
-34.3 |
7.3 |
Abbreviation: DXA = dual-energy X-ray absorptiometry.
Notes: Enrolled n=171; completers with both baseline and week 72 DXA n=140.
aData are model-based estimates.
Back to Content Overview .
Safety Results From ATTAIN-1
The overall safety profile of orforglipron in ATTAIN-1 was consistent with the established GLP-1 receptor agonist class.1
The most commonly reported AEs were gastrointestinal-related. These events were generally mild to moderate in severity and started mainly during dose escalation in orforglipron-treated participants.1
The proportion of participants that discontinued due to gastrointestinal AEs were
-
3.5% to 7.0% of orforglipron-treated participants, and
-
0.4% of placebo participants.1
An overview of AEs and AEs that occurred in ≥5% of participants are presented in Overview of Adverse Events and Adverse Events Occurring in ≥5% of Participants in the ATTAIN-1 Study, respectively.
Adverse Eventa |
Orforglipron 6 mg |
Orforglipron 12 mg |
Orforglipron 36 mg |
Placebo |
Overall |
Any AE emerging during treatment |
603 (83.4) |
627 (86.6) |
620 (85.2) |
763 (80.5) |
2613 (83.7) |
Serious AEs |
40 (5.5) |
39 (5.4) |
28 (3.8) |
46 (4.9) |
153 (4.9) |
Deathsb |
1 (0.1) |
1 (0.1) |
0 (0.0) |
1 (0.1) |
3 (0.1) |
AEs leading to discontinuation of study treatment |
38 (5.3) |
57 (7.9) |
75 (10.3) |
26 (2.7) |
196 (6.3) |
GI disorders leading to discontinuation of study treatment |
25 (3.5) |
38 (5.2) |
51 (7.0) |
4 (0.4) |
118 (3.8) |
Abbreviations: AE = adverse event; GI gastrointestinal.
aData are n (%) in safety population.
bCauses of death were reported as follows: undetermined for the participant in the 6 mg group orforglipron group, metastatic ovarian cancer in the participant in the 12 mg orforglipron group, and pulmonary embolism for the participant in the placebo group. Deaths were also counted as serious AEs and discontinuation of the trial regimen owing to AEs.
Adverse Eventa |
Orforglipron 6 mg |
Orforglipron 12 mg |
Orforglipron 36 mg |
Placebo |
Overall |
Nausea |
209 (28.9) |
260 (35.9) |
245 (33.7) |
99 (10.4) |
813 (26.0) |
Constipation |
157 (21.7) |
216 (29.8) |
185 (25.4) |
88 (9.3) |
646 (20.7) |
Diarrhea |
152 (21.0) |
165 (22.8) |
168 (23.1) |
91 (9.6) |
576 (18.4) |
Vomiting |
94 (13.0) |
155 (21.4) |
175 (24.0) |
33 (3.5) |
457 (14.6) |
Dyspepsia |
95 (13.1) |
117 (16.2) |
103 (14.1) |
47 (5.0) |
362 (11.6) |
URTI |
75 (10.4) |
75 (10.4) |
64 (8.8) |
103 (10.9) |
317 (10.2) |
Headache |
62 (8.6) |
75 (10.4) |
71 (9.8) |
71 (7.5) |
279 (8.9) |
Influenza |
68 (9.4) |
58 (8.0) |
44 (6.0) |
73 (7.7) |
243 (7.8) |
Nasopharyngitis |
55 (7.6) |
61 (8.4) |
47 (6.5) |
74 (7.8) |
237 (7.6) |
Abdominal distension |
52 (7.2) |
68 (9.4) |
62 (8.5) |
32 (3.4) |
214 (6.9) |
COVID-19 |
44 (6.1) |
52 (7.2) |
54 (7.4) |
50 (5.3) |
200 (6.4) |
Decreased appetite |
42 (5.8) |
61 (8.4) |
53 (7.3) |
30 (3.2) |
186 (6.0) |
Abdominal pain upper |
44 (6.1) |
45 (6.2) |
57 (7.8) |
33 (3.5) |
179 (5.7) |
Gastroenteritis |
45 (6.2) |
42 (5.8) |
50 (6.9) |
36 (3.8) |
173 (5.5) |
Back pain |
34 (4.7) |
39 (5.4) |
45 (6.2) |
54 (5.7) |
172 (5.5) |
Arthralgia |
34 (4.7) |
37 (5.1) |
35 (4.8) |
60 (6.3) |
166 (5.3) |
Abdominal pain |
38 (5.3) |
50 (6.9) |
44 (6.0) |
25 (2.6) |
157 (5.0) |
Anxiety |
37 (5.1) |
29 (4.0) |
27 (3.7) |
64 (6.8) |
157 (5.0) |
Eructation |
44 (6.1) |
43 (5.9) |
55 (7.6) |
10 (1.1) |
152 (4.9) |
GERD |
40 (5.5) |
42 (5.8) |
46 (6.3) |
21 (2.2) |
149 (4.8) |
Flatulence |
31 (4.3) |
40 (5.5) |
41 (5.6) |
17 (1.8) |
129 (4.1) |
Alopecia |
30 (4.1) |
36 (5.0) |
39 (5.4) |
23 (2.4) |
128 (4.1) |
Fatigue |
26 (3.6) |
25 (3.5) |
37 (5.1) |
15 (1.6) |
103 (3.3) |
Abbreviations: GERD = gastroesophageal reflux disease; URTI = upper respiratory tract infection.
aData are n (%) in safety population.
Five cases of adjudication-confirmed mild pancreatitis were reported in participants receiving orforglipron (1 participant in the orforglipron 6 mg group and 2 participants each from the 12 mg and 36 mg orforglipron dose groups) with none reporting complications.1
A total of 8 participants (7 orforglipron-treated participants and 1 placebo-treated participant) experienced transaminase elevations ≥10x upper limit of normal (ULN). For all 7 orforglipron participants, alternative causes were identified.1
Two participants in the orforglipron groups had elevated total bilirubin >2x ULN with ALT elevation >3x ULN. Both cases had alternative causes and were not associated with drug-induced liver injury.1
There were no cases of medullary thyroid cancer.1
At week 72, mean pulse rate increased by
- 4.3 to 5.3 beats per minute across orforglipron doses, and
- 0.8 beats per minute with placebo.1
Back to Content Overview .
Future Data Release
More results from the ATTAIN phase 3 clinical trial program will be shared later this year, along with findings from the ACHIEVE phase 3 clinical trial program evaluating orforglipron for adults with type 2 diabetes.2
Back to Content Overview .
References
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
1Wharton S, Aronne LJ, Stefanski A, et al. Orforglipron, an oral small molecule GLP-1R agonist for obesity treatment. N Engl J Med. 2025;393(12):1123-1135. https://doi.org/10.1056/NEJMoa2511774
2Lilly's oral GLP-1, orforglipron, delivers weight loss of up to an average of 27.3 lbs in first of two pivotal phase 3 trials in adults with obesity. Press release. Eli Lilly and Company; August 7, 2025. Accessed August 7, 2025. https://investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-delivers-weight-loss-average-273
3Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Appendix
Baseline Demographics and Clinical Characteristics
Parametera |
Orforglipron 6 mg |
Orforglipron 12 mg |
Orforglipron 36 mg |
Placebo |
Age, years |
44.9 ± 12.1 |
45.4 ± 12.6 |
44.9 ± 11.9 |
45.1 ± 11.9 |
Female, n (%) |
469 (64.9) |
467 (64.4) |
465 (63.7) |
608 (64.1) |
Race or ethnic groupb, n (%) |
||||
American Indian or Alaska Native |
2 (0.3) |
3 (0.4) |
2 (0.3) |
4 (0.4) |
Asian |
202 (28.3) |
201 (28.1) |
214 (29.6) |
267 (28.5) |
Black or African American |
68 (9.5) |
60 (8.4) |
67 (9.3) |
72 (7.7) |
White |
408 (57.1) |
405 (56.6) |
394 (54.4) |
539 (57.5) |
Native Hawaiian or other Pacific Islander |
0 (0.0) |
1 (0.1) |
0 (0.0) |
2 (0.2) |
Multiple |
35 (4.9) |
45 (6.3) |
47 (6.5) |
54 (5.8) |
Hispanic or Latino, n (%) |
273 (37.8) |
275 (37.9) |
258 (35.3) |
369 (38.9) |
Body weight, kg |
103.2 ± 21.7 |
102.2 ± 21.6 |
103.1 ± 23.2 |
103.9 ± 22.0 |
BMIc, kg/m² |
37.0 ± 6.5 |
36.7 ± 6.5 |
36.9 ± 6.7 |
37.1 ± 6.3 |
BMI category, n (%) |
||||
<30 |
62 (8.6) |
72 (9.9) |
68 (9.3) |
86 (9.1) |
≥30 to <35 |
263 (36.4) |
272 (37.5) |
285 (39.0) |
331 (34.9) |
≥35 to <40 |
202 (27.9) |
198 (27.3) |
183 (25.1) |
266 (28.0) |
≥40 |
196 (27.1) |
183 (25.2) |
194 (26.6) |
266 (28.0) |
Waist circumference, cm |
112.2 ± 14.1 |
112.0 ± 14.2 |
112.4 ± 15.3 |
112.8 ± 14.5 |
Blood pressure, mm Hg |
||||
Systolic |
125.4 ± 14.1 |
125.1 ± 13.7 |
125.8 ± 15.9 |
125.8 ± 14.5 |
Diastolic |
81.0 ± 9.3 |
81.2 ± 9.4 |
80.9 ± 10.1 |
81.8 ± 9.9 |
Lipid parameters, mg/dL |
||||
Total cholesterol |
196.2 (37.6) |
195.0 (39.0) |
196.3 (39.5) |
196.5 (39.5) |
HDL cholesterol |
49.6 (12.5) |
50.1 (12.4) |
48.5 (12.6) |
49.3 (12.4) |
LDL cholesterol |
119.6 (32.2) |
118.3 (34.1) |
119.4 (33.6) |
119.0 (33.6) |
Non-HDL cholesterol |
146.4 (36.1) |
144.6 (38.0) |
147.5 (38.7) |
147.0 (38.1) |
VLDL cholesterol |
26.1 (11.8) |
25.9 (11.7) |
27.3 (13.2) |
27.3 (12.9) |
Triglycerides |
135.4 (72.5) |
133.5 (75.8) |
142.8 (89.1) |
142.4 (91.9) |
Abbreviations: BMI = body mass index; HDL = high-density lipoprotein; LDL = low-density lipoprotein; VLDL = very-low-density lipoprotein.
aData are mean ± SD, unless otherwise noted.
bRace or ethnic group was reported by participants.
cBody-mass index is the weight in kilograms divided by the square of the height in meters.
Parameter |
Orforglipron 6 mg |
Orforglipron 12 mg |
Orforglipron 36 mg |
Placebo |
Clinical Characteristics |
||||
eGFRa, mL/min/1.73 m² |
93.1 ± 18.7 |
92.5 ± 18.7 |
92.8 ± 18.4 |
92.4 ± 18.5 |
Prediabetes, n (%) |
258 (35.7) |
260 (35.9) |
265 (36.3) |
344 (36.2) |
HbA1c, % |
5.6 ± 0.4 |
5.6 ± 0.3 |
5.6 ± 0.3 |
5.6 ± 0.3 |
Fasting glucose, mg/dL |
92.6 ± 10.0 |
92.1 ± 10.0 |
93.0 ± 10.5 |
92.4 ± 10.0 |
Fasting insulin, mIU/L |
19.1 ± 13.9 |
18.5 ± 12.4 |
19.0 ± 12.3 |
19.0 ± 13.6 |
hsCRP, mg/L |
5.6 ± 6.9 |
5.7 ± 7.6 |
5.5 ± 7.1 |
5.9 ± 7.9 |
Duration of obesity, years |
13.5 ± 11.1 |
13.7 ± 10.6 |
13.4 ± 11.1 |
13.6 ± 10.9 |
Pulse, beats/min |
73.0 ± 10.3 |
73.0 ± 9.9 |
73.5 ± 10.8 |
73.7 ± 10.1 |
Comorbiditiesb, n (%) |
||||
Hypertension |
294 (40.7) |
276 (38.1) |
288 (39.5) |
378 (39.8) |
Dyslipidemia |
278 (38.5) |
282 (38.9) |
284 (38.9) |
386 (40.7) |
Coronary artery disease |
11 (1.5) |
13 (1.8) |
11 (1.5) |
9 (0.9) |
Cerebrovascular disease |
7 (1.0) |
15 (2.1) |
13 (1.8) |
12 (1.3) |
Renal disease |
25 (3.5) |
23 (3.2) |
20 (2.7) |
24 (2.5) |
Female reproductive disordersc |
64 (13.6) |
65 (13.9) |
70 (15.1) |
82 (13.5) |
Dysmenorrhea/menstrual cycle abnormal/infertility |
59 (12.6) |
54 (11.6) |
63 (13.5) |
71 (11.7) |
PCOS |
12 (2.6) |
22 (4.7) |
18 (3.9) |
21 (3.5) |
Obstructive sleep apnea |
76 (10.5) |
67 (9.2) |
92 (12.6) |
109 (11.5) |
Osteoarthritis |
89 (12.3) |
85 (11.7) |
78 (10.7) |
112 (11.8) |
Anxiety/depression |
117 (16.2) |
104 (14.3) |
111 (15.2) |
161 (17.0) |
MASLD |
142 (19.6) |
154 (21.2) |
147 (20.1) |
195 (20.5) |
Asthma or COPD |
54 (7.5) |
57 (7.9) |
63 (8.6) |
68 (7.2) |
Gout or hyperuricemia |
77 (10.7) |
79 (10.9) |
83 (11.4) |
90 (9.5) |
Abbreviations: CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration; COPD = chronic obstructive pulmonary disease; eGFR = estimated glomerular filtration rate; HbA1c = glycated hemoglobin; hsCRP = high-sensitivity C-reactive protein; MASLD = metabolic dysfunction-associated steatotic liver disease; PCOS = polycystic ovary syndrome.
a The eGFR was calculated according to the serum cystatin C-based CKD-EPI equation.
b Comorbidities were assessed through a review of medical history.
cPercentage is based on total number of female participants in the respective treatment group.
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Date of Last Review: September 05, 2025