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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-JE-GPHZ | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to learn more about tirzepatide in participants with obesity disease. The study will also measure how Tirzepatide affects body weight with a low-calorie diet and increased physical activity. The study will last around 72 Weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 Milligrams (mg) Tirzepatide | Experimental | Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered subcutaneously (SC) once weekly (QW). |
|
| 15 mg Tirzepatide | Experimental | Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW. |
|
| Placebo | Placebo Comparator | Participants received matching placebo administered SC QW. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change in Body Weight | Mean percent change in body weight was measured. Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with Baseline + impaired glucose tolerance (IGT) at Screening + Hyperlipidemia at Screening + non-alcoholic fatty liver disease (NAFLD) at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | Baseline, 72 Weeks |
| Percentage of Participants Who Achieve ≥5% Body Weight Reduction | Percentage of Participants Who Achieve ≥5% Body Weight Reduction | Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Had Improvement in Obesity-related Health Problems | Percentage of participants who had improvement in obesity-related health problems | Week 72 |
| Change From Baseline in Fasting Glucose for Participants With IGT at Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLilly (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT -5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kohnodai Hospital, National Center for Global Health and Medicine | Ichikawa | Chiba | 272-8516 | Japan | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42287159 | Derived | Node K, Batterham RL, Liu-Seifert H, Li R, Yoshino M, Oura T, Tanizawa Y, Komuro I. Post hoc analysis of SURMOUNT-J: tirzepatide versus placebo and predicted 10-year cardiovascular disease risk in Japanese adults with obesity disease. Curr Med Res Opin. 2026 Jun 13:1-13. doi: 10.1080/03007995.2026.2686052. Online ahead of print. | |
| 42108080 |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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267 participants were randomized in the study. However, due to good clinical practice (GCP) compliance issues identified at one of the investigative sites, all 42 participants from that site were excluded from the study analyses
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| ID | Title | Description |
|---|---|---|
| FG000 | 10 Milligrams (mg) Tirzepatide | Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered subcutaneously (SC) once weekly (QW). |
| FG001 | 15 mg Tirzepatide | Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW. |
| FG002 | Placebo | Participants received matching placebo administered SC QW. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 10 mg Tirzepatide | Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW. |
| BG001 | 15 mg Tirzepatide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Percent Change in Body Weight | Mean percent change in body weight was measured. Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with Baseline + impaired glucose tolerance (IGT) at Screening + Hyperlipidemia at Screening + non-alcoholic fatty liver disease (NAFLD) at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline, 72 Weeks |
|
Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 10 mg Tirzepatide | Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide SC QW . |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 11, 2021 | Jun 16, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 11, 2023 | Jun 16, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009748 | Nutrition Disorders |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
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| Placebo | Other | Administered SC |
|
Change from Baseline in Fasting Glucose for Participants with IGT at Baseline. LS mean was determined by MMRM model with = Baseline + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. |
| Baseline, Week 72 |
| Change From Baseline in Oral Glucose Tolerance (OGTT) 2-hr Glucose for Participants With Impaired Glucose Tolerance (IGT) at Baseline | Change from Baseline in OGTT 2-hr Glucose for Participants with IGT at Baseline. LS mean was determined by MMRM model with Baseline + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | Baseline, Week 72 |
| Percent Change From Baseline in Fasting Lipids [Triglycerides (TG)] for Participants With Hyperlipidemia at Baseline | Percent Change from Baseline in Fasting Lipids TG for Participants with Hyperlipidemia at Baseline. LS mean was determined by MMRM model with log (Baseline) + NAFLD at Screening + IGT at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | Baseline, Week 72 |
| Percent Change From Baseline in Hepatic Fat Fraction (HFF) for Participants With Non-alcoholic Fatty Liver Disease [NAFLD] | Percent Change from Baseline in HFF for participants diagnosed as NAFLD by MRI at Baseline. LS mean was determined by ANCOVA model with Baseline + Hyperlipidemia at Screening + IGT at Screening + Sex + Treatment (Type III sum of squares) as variables. Percent Change from Baseline in HFF for participants with NAFLD is reported. NAFLD was diagnosed by Magnetic Resonance Imaging (MRI) at Baseline. This was evaluated only for participants who were diagnosed with NAFLD at baseline by MRI. | Baseline, Week 72 |
| Percentage of Participants Who Achieved Improvements of IGT | Percentage of Participants Who Achieved Improvements of IGT. This was evaluated only for participants with IGT at baseline. | Week 72 |
| Percentage of Participants Who Achieved Improvements of Hyperlipidemia | Percentage of Participants Who Achieved Improvements of Hyperlipidemia. This was evaluated only for participants with hyperlipidemia at baseline. | Week 72 |
| Percentage of Participants Who Achieved Improvements of NAFLD | Percentage of Participants Who Achieved Improvements of NAFLD. This was evaluated only for participants who were diagnosed as NAFLD by MRI at Baseline. | Week 72 |
| Percentage of Participants Who Achieve ≥10% Body Weight Reduction | Percentage of Participants Who Achieve ≥10% body weight reduction. | Week 72 |
| Percentage of Participants Who Achieve ≥15% Body Weight Reduction | Percentage of Participants Who Achieve ≥15% body weight reduction. | Week 72 |
| Change From Baseline in Absolute Body Weight | Change from Baseline in Absolute Body Weight. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | Baseline, Week 72 |
| Change From Baseline in Body Mass Index (BMI) | Change from Baseline in BMI. LS mean was determined using MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | Baseline, Week 72 |
| Percent Change From Baseline in Visceral Adipose Tissue (VAT) | Percent Change from Baseline in VAT. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | Baseline, Week 72 |
| Percent Change From Baseline in Subcutaneous Adipose Tissue (SAT) | Percent Change from Baseline in SAT. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | Baseline, Week 72 |
| Change From Baseline in VAT/SAT Ratio | Change from Baseline in VAT/SAT Ratio. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | Baseline, Week 72 |
| Percentage of Participants Who Achieved VAT <100 Square Centimeter (cm²) From Baseline for Participants With VAT≥100 cm² at Baseline | Percentage of Participants Who Achieve VAT <100 cm² from Baseline for participants with VAT≥100 cm² at Baseline. | Week 72 |
| Change From Baseline in Waist Circumference | Change from Baseline in Waist Circumference. LS mean was determined using MMRM model with = Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | Baseline, Week 72 |
| Change From Baseline in Hemoglobin A1c (HbA1c) | Change from Baseline in HbA1c was assessed only for Participants with IGT at Baseline. LS mean was determined using MMRM model with = Baseline + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | Baseline, Week 72 |
| Change From Baseline in Fasting Insulin for Participants With IGT at Baseline | Change from Baseline in Fasting Insulin for Participants with IGT at Baseline. LS mean was determined using MMRM model log(Baseline) + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | Baseline, Week 72 |
| Change From Baseline in Systolic Blood Pressure | Change from Baseline in Systolic Blood Pressure. LS mean was determined using MMRM model with Baseline + Hyperlipidemia at Screening + NAFLD at Screening + IGT at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | Baseline, Week 72 |
| Change From Baseline in Diastolic Blood Pressure | Change from Baseline in Diastolic Blood Pressure. LS mean was determined using MMRM model with Baseline + Hyperlipidemia at Screening + NAFLD at Screening + IGT at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | Baseline, Week 72 |
| Change From Baseline in Short Form 36 Version 2 Health Survey (SF-36v2) Acute Form Physical Functioning Domain Score | The SF-36v2 acute form, 1-week recall assesses participants' health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Information from these 8 domains is further aggregated into 2 health component summary scores: Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths. Scoring of each domain and both summary scores are norm based and presented in the form of T scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores. LS mean was determined using ANCOVA model with Week 0 (Visit 3) + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment (Type III sum of squares) as variables. | Baseline, Week 72 |
| Change From Baseline in Impact of Weight on Quality-of-Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score | The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related HRQoL: Physical (7 items) and Psychosocial (13 items). A 5-item subset of the Physical domain - the Physical Function composite - is also supported. Items in the Physical Function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. LS mean was determined using ANCOVA model with Week 0 (Visit 3) + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment (Type III sum of squares) as variables. | Baseline, Week 72 |
| Change From Baseline in Euro Quality of Life Five Dimensions (EQ-5D-5L) | The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It comprises of 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, unable to perform/extreme problems). In addition to the health profile, a single health state index value can be derived based on a formula that attaches weights to each of the levels in each dimension. This index value ranges between Ë‚0 (where 0 is a health state equivalent to death; negative values are valued as worse than dead) to 1 (perfect health). LS mean was determined using ANCOVA model with Week 0 (Visit 3) + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment (Type III sum of squares) as variables. | Baseline, Week 72 |
| Saiseikai Matsuyama Hospital |
| Matsuyama |
| Ehime |
| 791-8026 |
| Japan |
| Takai Internal Medicine Clinic | Kamakura-shi | Kanagawa | 247-0056 | Japan |
| Saiseikai Yokohamashi Tobu Hospital | Yokohama | Kanagawa | 2308765 | Japan |
| Motomachi Takatsuka Naika Clinic | Yokohama | Kanagawa | 231-0023 | Japan |
| Osaka Saiseikai Suita hospital | Suita | Osaka | 564-0013 | Japan |
| Medical Corporation Heishinkai OCROM Clinic | Suita-shi | Osaka | 565-0853 | Japan |
| Takatsuki Red Cross Hospital | Takatsuki | Osaka | 569-1045 | Japan |
| The Institute for Adult Disease, Asahi Life Foundation | Chuo-ku | Tokyo | 103-0002 | Japan |
| Tokyo-Eki Center-building Clinic | Chuo-ku | Tokyo | 103-0027 | Japan |
| Medical Corporation Chiseikai Tokyo Center Clinic | Chuo-ku | Tokyo | 103-0028 | Japan |
| Fukuwa Clinic | Chuo-ku | Tokyo | 104-0031 | Japan |
| Saiseikai Central Hospital | Minato-Ku | Tokyo | 108-0073 | Japan |
| Shimokitazawa Tomo Clinic | Setagaya-ku | Tokyo | 155-0031 | Japan |
| Miho Clinic | Shinagawa-ku | Tokyo | 141 0032 | Japan |
| Medical Corporation Heishinkai ToCROM Clinic | Shinjuku-ku | Tokyo | 160 0008 | Japan |
| Yamagata Tokushukai Hospital | Yamagata | Yamagata | 990-0834 | Japan |
| AMC Nishiumeda Clinic | Osaka | 530-0001 | Japan |
| Masuzaki H, Nagashima H, Shingaki T, Oura T, Tatsuno I. Effect of Tirzepatide on Health-Related Quality of Life in Japanese Patients With Obesity Disease: Patient-Reported Outcomes From the SURMOUNT-J Study. Diabetes Obes Metab. 2026 Aug;28(8):6639-6648. doi: 10.1111/dom.70850. Epub 2026 May 10. |
| 41290555 | Derived | Yokote K, Fukushima Y, Shingaki T, Oura T, Ogawa W. Association of baseline characteristics with clinical outcomes of tirzepatide treatment in Japanese patients with obesity disease: A subgroup analysis of the SURMOUNT-J trial. Diabetes Obes Metab. 2026 Feb;28(2):1278-1287. doi: 10.1111/dom.70315. Epub 2025 Nov 25. |
| 40031941 | Derived | Kadowaki T, Kiyosue A, Shingaki T, Oura T, Yokote K. Efficacy and safety of once-weekly tirzepatide in Japanese patients with obesity disease (SURMOUNT-J): a multicentre, randomised, double-blind, placebo-controlled phase 3 trial. Lancet Diabetes Endocrinol. 2025 May;13(5):384-396. doi: 10.1016/S2213-8587(24)00377-2. Epub 2025 Feb 28. |
| Withdrawal by Subject |
|
| Participants Excluded Due to GCP Compliance Issue |
|
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
| BG002 | Placebo | Participants received matching placebo administered SC QW. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG001 |
| 15 mg Tirzepatide |
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW. |
| OG002 | Placebo | Participants received matching placebo administered SC QW. |
|
|
|
| Primary | Percentage of Participants Who Achieve ≥5% Body Weight Reduction | Percentage of Participants Who Achieve ≥5% Body Weight Reduction | All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug, had a baseline and at least one post-baseline value for this outcome. | Posted | Number | Percentage of participants | Week 72 |
|
|
|
|
| Secondary | Percentage of Participants Who Had Improvement in Obesity-related Health Problems | Percentage of participants who had improvement in obesity-related health problems | All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and evaluable data for this outcome. | Posted | Number | Percentage of participants | Week 72 |
|
|
|
|
| Secondary | Change From Baseline in Fasting Glucose for Participants With IGT at Baseline | Change from Baseline in Fasting Glucose for Participants with IGT at Baseline. LS mean was determined by MMRM model with = Baseline + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants, excluding the GCP compliance investigative site, who had IGT at baseline, received at least one dose of study drug and had evaluable data for this outcome. | Posted | Least Squares Mean | Standard Error | milligrams per deciliter (mg/dL) | Baseline, Week 72 |
|
|
|
|
| Secondary | Change From Baseline in Oral Glucose Tolerance (OGTT) 2-hr Glucose for Participants With Impaired Glucose Tolerance (IGT) at Baseline | Change from Baseline in OGTT 2-hr Glucose for Participants with IGT at Baseline. LS mean was determined by MMRM model with Baseline + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants, excluding the GCP compliance investigative site, who had IGT at baseline, received at least one dose of study drug and had evaluable data for this outcome. | Posted | Least Squares Mean | Standard Error | milligrams per deciliter (mg/dL) | Baseline, Week 72 |
|
|
|
|
| Secondary | Percent Change From Baseline in Fasting Lipids [Triglycerides (TG)] for Participants With Hyperlipidemia at Baseline | Percent Change from Baseline in Fasting Lipids TG for Participants with Hyperlipidemia at Baseline. LS mean was determined by MMRM model with log (Baseline) + NAFLD at Screening + IGT at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants, excluding the GCP compliance investigative site, who had hyperlipidemia at baseline, received at least one dose of study drug and had evaluable data for this outcome. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline, Week 72 |
|
|
|
|
| Secondary | Percent Change From Baseline in Hepatic Fat Fraction (HFF) for Participants With Non-alcoholic Fatty Liver Disease [NAFLD] | Percent Change from Baseline in HFF for participants diagnosed as NAFLD by MRI at Baseline. LS mean was determined by ANCOVA model with Baseline + Hyperlipidemia at Screening + IGT at Screening + Sex + Treatment (Type III sum of squares) as variables. Percent Change from Baseline in HFF for participants with NAFLD is reported. NAFLD was diagnosed by Magnetic Resonance Imaging (MRI) at Baseline. This was evaluated only for participants who were diagnosed with NAFLD at baseline by MRI. | All participants, excluding the GCP compliance investigative site, who were diagnosed as NAFLD by MRI at baseline and received at least one dose of study drug and had evaluable data for this outcome. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline, Week 72 |
|
|
|
|
| Secondary | Percentage of Participants Who Achieved Improvements of IGT | Percentage of Participants Who Achieved Improvements of IGT. This was evaluated only for participants with IGT at baseline. | All participants, excluding the GCP compliance investigative site, who had IGT at baseline, received at least one dose of study drug and had evaluable data for this outcome. | Posted | Number | Percentage of participants | Week 72 |
|
|
|
|
| Secondary | Percentage of Participants Who Achieved Improvements of Hyperlipidemia | Percentage of Participants Who Achieved Improvements of Hyperlipidemia. This was evaluated only for participants with hyperlipidemia at baseline. | All participants, excluding the GCP compliance investigative site, with hyperlipidemia at baseline, received at least one dose of study drug and had evaluable data for this outcome. | Posted | Number | Percentage of participants | Week 72 |
|
|
|
|
| Secondary | Percentage of Participants Who Achieved Improvements of NAFLD | Percentage of Participants Who Achieved Improvements of NAFLD. This was evaluated only for participants who were diagnosed as NAFLD by MRI at Baseline. | All participants, excluding the GCP compliance investigative site, diagnosed as NAFLD by MRI at baseline, received at least one dose of study drug, and had evaluable data for this outcome. | Posted | Number | Percentage of participants | Week 72 |
|
|
|
|
| Secondary | Percentage of Participants Who Achieve ≥10% Body Weight Reduction | Percentage of Participants Who Achieve ≥10% body weight reduction. | All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome. | Posted | Number | Percentage of participants | Week 72 |
|
|
|
|
| Secondary | Percentage of Participants Who Achieve ≥15% Body Weight Reduction | Percentage of Participants Who Achieve ≥15% body weight reduction. | All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome. | Posted | Number | Percentage of participants | Week 72 |
|
|
|
|
| Secondary | Change From Baseline in Absolute Body Weight | Change from Baseline in Absolute Body Weight. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome. | Posted | Least Squares Mean | Standard Error | kilograms (kg) | Baseline, Week 72 |
|
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|
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| Secondary | Change From Baseline in Body Mass Index (BMI) | Change from Baseline in BMI. LS mean was determined using MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome. | Posted | Least Squares Mean | Standard Error | kilograms per metres squared (kg/m^2) | Baseline, Week 72 |
|
|
|
|
| Secondary | Percent Change From Baseline in Visceral Adipose Tissue (VAT) | Percent Change from Baseline in VAT. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline, Week 72 |
|
|
|
|
| Secondary | Percent Change From Baseline in Subcutaneous Adipose Tissue (SAT) | Percent Change from Baseline in SAT. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline, Week 72 |
|
|
|
|
| Secondary | Change From Baseline in VAT/SAT Ratio | Change from Baseline in VAT/SAT Ratio. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome. | Posted | Least Squares Mean | Standard Error | ratio | Baseline, Week 72 |
|
|
|
|
| Secondary | Percentage of Participants Who Achieved VAT <100 Square Centimeter (cm²) From Baseline for Participants With VAT≥100 cm² at Baseline | Percentage of Participants Who Achieve VAT <100 cm² from Baseline for participants with VAT≥100 cm² at Baseline. | All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome. | Posted | Number | Percentage of participants | Week 72 |
|
|
|
|
| Secondary | Change From Baseline in Waist Circumference | Change from Baseline in Waist Circumference. LS mean was determined using MMRM model with = Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome. | Posted | Least Squares Mean | Standard Error | centimeters (cm) | Baseline, Week 72 |
|
|
|
|
| Secondary | Change From Baseline in Hemoglobin A1c (HbA1c) | Change from Baseline in HbA1c was assessed only for Participants with IGT at Baseline. LS mean was determined using MMRM model with = Baseline + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants, excluding the GCP compliance investigative site, who had IGT at baseline, received at least one dose of study drug and had evaluable data for this outcome. | Posted | Least Squares Mean | Standard Error | Percentage of HbA1c | Baseline, Week 72 |
|
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|
|
| Secondary | Change From Baseline in Fasting Insulin for Participants With IGT at Baseline | Change from Baseline in Fasting Insulin for Participants with IGT at Baseline. LS mean was determined using MMRM model log(Baseline) + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants, excluding the GCP compliance investigative site, who had IGT at baseline, received at least one dose of study drug, and had evaluable data for this outcome. | Posted | Least Squares Mean | Standard Error | milli-international units/liter (mIU/L) | Baseline, Week 72 |
|
|
|
|
| Secondary | Change From Baseline in Systolic Blood Pressure | Change from Baseline in Systolic Blood Pressure. LS mean was determined using MMRM model with Baseline + Hyperlipidemia at Screening + NAFLD at Screening + IGT at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome. | Posted | Least Squares Mean | Standard Error | millimeters of Mercury (mmHg) | Baseline, Week 72 |
|
|
|
|
| Secondary | Change From Baseline in Diastolic Blood Pressure | Change from Baseline in Diastolic Blood Pressure. LS mean was determined using MMRM model with Baseline + Hyperlipidemia at Screening + NAFLD at Screening + IGT at Screening + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome. | Posted | Least Squares Mean | Standard Error | millimeters of Mercury (mmHg) | Baseline, Week 72 |
|
|
|
|
| Secondary | Change From Baseline in Short Form 36 Version 2 Health Survey (SF-36v2) Acute Form Physical Functioning Domain Score | The SF-36v2 acute form, 1-week recall assesses participants' health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Information from these 8 domains is further aggregated into 2 health component summary scores: Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths. Scoring of each domain and both summary scores are norm based and presented in the form of T scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores. LS mean was determined using ANCOVA model with Week 0 (Visit 3) + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment (Type III sum of squares) as variables. | All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, Week 72 |
|
|
|
|
| Secondary | Change From Baseline in Impact of Weight on Quality-of-Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score | The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related HRQoL: Physical (7 items) and Psychosocial (13 items). A 5-item subset of the Physical domain - the Physical Function composite - is also supported. Items in the Physical Function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. LS mean was determined using ANCOVA model with Week 0 (Visit 3) + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment (Type III sum of squares) as variables. | All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, Week 72 |
|
|
|
|
| Secondary | Change From Baseline in Euro Quality of Life Five Dimensions (EQ-5D-5L) | The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It comprises of 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, unable to perform/extreme problems). In addition to the health profile, a single health state index value can be derived based on a formula that attaches weights to each of the levels in each dimension. This index value ranges between Ë‚0 (where 0 is a health state equivalent to death; negative values are valued as worse than dead) to 1 (perfect health). LS mean was determined using ANCOVA model with Week 0 (Visit 3) + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment (Type III sum of squares) as variables. | All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, Week 72 |
|
|
|
|
| 0 |
| 73 |
| 8 |
| 73 |
| 59 |
| 73 |
| EG001 | 15 mg Tirzepatide | Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW. | 0 | 77 | 5 | 77 | 65 | 77 |
| EG002 | Placebo | Participants received matching placebo administered SC QW. | 0 | 75 | 5 | 75 | 51 | 75 |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
|
| Rhegmatogenous retinal detachment | Eye disorders | MedDRA 26.0 | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Covid-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Otitis media chronic | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Brain stem infarction | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
|
| Extrasystoles | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
|
| Paroxysmal arrhythmia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
|
| Gilbert's syndrome | Congenital, familial and genetic disorders | MedDRA 26.0 | Systematic Assessment |
|
| Conductive deafness | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 26.0 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 26.0 | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 26.0 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 26.0 | Systematic Assessment |
|
| Retinal vein occlusion | Eye disorders | MedDRA 26.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Gastric polyps | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Pancreatic cyst | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Injection site oedema | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Injection site urticaria | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Vaccination site swelling | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Vaccination site warmth | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
|
| Gallbladder polyp | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
|
| Anaphylactic shock | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Bartholin's abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Conjunctivitis viral | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Covid-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Folliculitis genital | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Helicobacter infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Infected bite | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Tinea manuum | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Chillblains | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Heat illness | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Immunisation reaction | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Post vaccination fever | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| Albumin urine present | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| Blood calcitonin increased | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| Catheterisation cardiac | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| Helicobacter test positive | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| Pancreatic enzymes increased | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| Prostatic specific antigen increased | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| Urine leukocyte esterase positive | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
|
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
|
| Hyperamylasaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Limb mass | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Spinal ligament ossification | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Abdominal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Gastrointestinal submucosal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Sweat gland tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Autonomic nervous system imbalance | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Intercostal neuralgia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Intracranial aneurysm | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Taste disorder | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Trigeminal neuralgia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Adjustment disorder | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
|
| Renal infarct | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
|
| Breast mass | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
|
| Intermenstrual bleeding | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
|
| Menopausal symptoms | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Nasal pruritus | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Vocal cord atrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Vocal cord inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Solar lentigo | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Appendicectomy | Surgical and medical procedures | MedDRA 26.0 | Systematic Assessment |
|
| Inguinal hernia repair | Surgical and medical procedures | MedDRA 26.0 | Systematic Assessment |
|
| Mass excision | Surgical and medical procedures | MedDRA 26.0 | Systematic Assessment |
|
| Transurethral prostatectomy | Surgical and medical procedures | MedDRA 26.0 | Systematic Assessment |
|
| Artery dissection | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
Not provided
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
| Odds Ratio (OR) |
| 153.57 |
| 2-Sided |
| 95 |
| 36.03 |
| 654.53 |
| Superiority |
| Odds Ratio (OR) |
| 38.27 |
| 2-Sided |
| 95 |
| 13.21 |
| 110.89 |
| Superiority |
| LS Mean Difference |
| -12.80 |
| 2-Sided |
| 95 |
| -16.56 |
| -9.05 |
| Superiority |
| LS Mean Difference |
| -64.82 |
| 2-Sided |
| 95 |
| -78.20 |
| -51.43 |
| Superiority |
| LS Mean Difference |
| -44.5 |
| 2-Sided |
| 95 |
| -52.7 |
| -34.9 |
| Superiority |
| LS Mean Difference |
| -50.4 |
| 2-Sided |
| 95 |
| -58.8 |
| -41.9 |
| Superiority |
| Odds Ratio (OR) |
| 70.66 |
| 2-Sided |
| 95 |
| 12.73 |
| 392.24 |
| Superiority |
| Odds Ratio (OR) |
| 15.67 |
| 2-Sided |
| 95 |
| 4.78 |
| 51.37 |
| Superiority |
| Odds Ratio (OR) |
| 40.01 |
| 2-Sided |
| 95 |
| 13.27 |
| 120.57 |
| Superiority |
| Odds Ratio (OR) |
| 318.02 |
| 2-Sided |
| 95 |
| 74.49 |
| 1357.79 |
| Superiority |
| Odds Ratio (OR) |
| 286.73 |
| 2-Sided |
| 95 |
| 50.68 |
| 1622.06 |
| Superiority |
| LS Mean Difference |
| -19.3 |
| 2-Sided |
| 95 |
| -21.6 |
| -17.0 |
| Superiority |
| LS Mean Difference |
| -7.1 |
| 2-Sided |
| 95 |
| -8.0 |
| -6.3 |
| Superiority |
| LS Mean Difference |
| -41.1 |
| 2-Sided |
| 95 |
| -47.8 |
| -34.4 |
| Superiority |
| LS Mean Difference |
| -31.5 |
| 2-Sided |
| 95 |
| -36.7 |
| -26.2 |
| Superiority |
| LS Mean Difference |
| -0.09 |
| 2-Sided |
| 95 |
| -0.15 |
| -0.03 |
| Superiority |
| Odds Ratio (OR) |
| 57.73 |
| 2-Sided |
| 95 |
| 8.68 |
| 383.88 |
| Superiority |
| LS Mean Difference |
| -15.3 |
| 2-Sided |
| 95 |
| -17.7 |
| -13.0 |
| Superiority |
| LS Mean Difference |
| -0.66 |
| 2-Sided |
| 95 |
| -0.77 |
| -0.55 |
| Superiority |
| LS Mean Difference |
| -4.55 |
| 2-Sided |
| 95 |
| -6.29 |
| -2.81 |
| Superiority |
| LS Mean Difference |
| -13.9 |
| 2-Sided |
| 95 |
| -17.7 |
| -10.1 |
| Superiority |
| LS Mean Difference |
| -6.8 |
| 2-Sided |
| 95 |
| -9.7 |
| -3.9 |
| Superiority |
| LS Mean Difference |
| 2.1 |
| 2-Sided |
| 95 |
| 1.1 |
| 3.2 |
| Superiority |
| LS Mean Difference |
| 10.8 |
| 2-Sided |
| 95 |
| 5.4 |
| 16.3 |
| Superiority |
| LS Mean Difference |
| 0.02 |
| 2-Sided |
| 95 |
| -0.01 |
| 0.05 |
| Superiority |