Clinical Trials List
Protocol NumberI8F-MC-GPHK
NCT Number(ClinicalTrials.gov Identfier)NCT04184622
2020-01-01 - 2024-08-08
Phase III
Terminated5
ICD-10E66.9
Obesity, unspecified
ICD-10E66.8
Other obesity
Efficacy and Safety of Tirzepatide Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight- Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-1)
-
Trial Applicant
ELI LILLY AND COMPANY(TAIWAN), INC.
-
Sponsor
Eli Lilly and Company
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Hua-Shui Hsu Division of Family Medicine
- 劉家嘉 Division of Family Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 林景翰 Division of Endocrinology
- Jin-Shang Wu Division of Family Medicine
- 杜業豐 Division of Endocrinology
- 張尹凡 Division of Family Medicine
- Chih-Jen Chang Division of Family Medicine
- Horng-Yih Ou Division of Endocrinology
- Hao-Chang Hung Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Terminated
Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight- Related Comorbidities
Objectives
Study I8F-MC-GPHK (GPHK, SURMOUNT-1) is a Phase 3, multicenter, randomized, placebocontrolled, double-blinded study, to investigate the safety and efficacy of 5-mg, 10-mg, and 15-mg tirzepatide QW, compared with placebo, when used in conjunction with a reduced-calorie diet and increased physical activity for body weight management in participants who do not have
T2DM and have obesity (BMI ≥30 kg/m2) or are overweight (BMI ≥27 kg/m2) with at least one weight-related comorbid condition (for example, hypertension, dyslipidemia, or cardiovascular disease). All participants will be randomized to at least 72 weeks of treatment to study the effects on body weight reduction. Participants who have prediabetes at randomization will be
studied for a total of 176 weeks of treatment to provide sufficient follow-up time to assess the effects of tirzepatide on progression to T2D and on long-term body weight changes.
Test Drug
Tirzepatide
Active Ingredient
Tirzepatide
Dosage Form
IVT
Dosage
2.5、5、7.5、10、12.5、15mg
Endpoints
Primary Outcome Measures :
Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 72 ]
Percent Change from Baseline in Body Weight
Percentage of Participants who Achieve ≥5% Body Weight Reduction [ Time Frame: Week 72 ]
Percentage of Participants who Achieve ≥5% Body Weight Reduction
Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 72 ]
Percent Change from Baseline in Body Weight
Percentage of Participants who Achieve ≥5% Body Weight Reduction [ Time Frame: Week 72 ]
Percentage of Participants who Achieve ≥5% Body Weight Reduction
Inclution Criteria
1. Have a BMI
≥30 kg/m2
or
≥27 kg/m2
and previously diagnosed with at least one of the following weight
related comorbidities:
o hypertension: treated or with systolic blood pressure (SBP) ≥130 mmHg
or diastolic blood pressure ≥80 mmHg
o dyslipidemia: treated or with low-density lipoprotein
(LDL) ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7
mmol/L), or high-density lipoprotein (HDL) <40 mg/dL (1.0 mmol/L)
for men or HDL<50 mg/dL (1.3 mmol/L) for women
o obstructive sleep apnea
o cardiovascular disease (for example, ischemic cardiovascular disease,
New York Heart Association (NYHA) Functional Class I-III heart
failure)
2. Have a history of at least one self-reported unsuccessful dietary effort to lose
body weight
3. In the investigator’s opinion, are well-motivated, capable, and willing to
learn how to self-inject study drug, as required for this protocol (visually impaired
persons who are not able to perform the injections must have the assistance of a
sighted individual trained to inject study drug; persons with physical limitations who
are not able to perform the injections must have the assistance of an individual trained
to inject study drug)
inject study drug (or receive an injection from a trained individual if visually
impaired or with physical limitations)
follow study procedures for the duration of the study, including, but not limited to:
follow lifestyle advice (for example, dietary restrictions and exercise plan), maintain
a study diary, and complete required questionnaires 4. Are 18 years or older
a. male participants:
Male participants with partners of childbearing potential should be willing
to use reliable contraceptive methods throughout the study and for 5 halflives of study drug plus 90 days, corresponding to 4 months after the last
injection.
b. female participants:
Female participants not of childbearing potential may participate and
include those who are:
o infertile due to surgical sterilization (hysterectomy, bilateral
oophorectomy or tubal ligation), congenital anomaly such as
Mullerian agenesis
o postmenopausal, defined as either
a woman at least 40 years of age with an intact uterus, not
on hormone therapy, who has cessation of menses for at
least 1 year without an alternative medical cause, AND a
follicle-stimulating hormone ≥40mIU/mL; women in this
category must test negative in pregnancy test prior to study
entry
or
a woman 55 or older not on hormone therapy, who has had
at least 12 months of spontaneous amenorrhea
or
a woman at least 55 years of age with a diagnosis of
menopause prior to starting hormone replacement therapy
Female participants of child-bearing potential (not surgically sterilized and
between menarche and 1-year postmenopausal) must:
o test negative for pregnancy at Visit 1 based on a serum pregnancy
test
and
o if sexually active, agree to use 2 forms of effective contraception,
where at least 1 form is highly effective, for the duration of the
trial and for 30 days thereafter
o not be breastfeeding
5. Have given written informed consent to participate in this study in accordance
with local regulations and the ethical review board (ERB) governing the study
site
≥30 kg/m2
or
≥27 kg/m2
and previously diagnosed with at least one of the following weight
related comorbidities:
o hypertension: treated or with systolic blood pressure (SBP) ≥130 mmHg
or diastolic blood pressure ≥80 mmHg
o dyslipidemia: treated or with low-density lipoprotein
(LDL) ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7
mmol/L), or high-density lipoprotein (HDL) <40 mg/dL (1.0 mmol/L)
for men or HDL<50 mg/dL (1.3 mmol/L) for women
o obstructive sleep apnea
o cardiovascular disease (for example, ischemic cardiovascular disease,
New York Heart Association (NYHA) Functional Class I-III heart
failure)
2. Have a history of at least one self-reported unsuccessful dietary effort to lose
body weight
3. In the investigator’s opinion, are well-motivated, capable, and willing to
learn how to self-inject study drug, as required for this protocol (visually impaired
persons who are not able to perform the injections must have the assistance of a
sighted individual trained to inject study drug; persons with physical limitations who
are not able to perform the injections must have the assistance of an individual trained
to inject study drug)
inject study drug (or receive an injection from a trained individual if visually
impaired or with physical limitations)
follow study procedures for the duration of the study, including, but not limited to:
follow lifestyle advice (for example, dietary restrictions and exercise plan), maintain
a study diary, and complete required questionnaires 4. Are 18 years or older
a. male participants:
Male participants with partners of childbearing potential should be willing
to use reliable contraceptive methods throughout the study and for 5 halflives of study drug plus 90 days, corresponding to 4 months after the last
injection.
b. female participants:
Female participants not of childbearing potential may participate and
include those who are:
o infertile due to surgical sterilization (hysterectomy, bilateral
oophorectomy or tubal ligation), congenital anomaly such as
Mullerian agenesis
o postmenopausal, defined as either
a woman at least 40 years of age with an intact uterus, not
on hormone therapy, who has cessation of menses for at
least 1 year without an alternative medical cause, AND a
follicle-stimulating hormone ≥40mIU/mL; women in this
category must test negative in pregnancy test prior to study
entry
or
a woman 55 or older not on hormone therapy, who has had
at least 12 months of spontaneous amenorrhea
or
a woman at least 55 years of age with a diagnosis of
menopause prior to starting hormone replacement therapy
Female participants of child-bearing potential (not surgically sterilized and
between menarche and 1-year postmenopausal) must:
o test negative for pregnancy at Visit 1 based on a serum pregnancy
test
and
o if sexually active, agree to use 2 forms of effective contraception,
where at least 1 form is highly effective, for the duration of the
trial and for 30 days thereafter
o not be breastfeeding
5. Have given written informed consent to participate in this study in accordance
with local regulations and the ethical review board (ERB) governing the study
site
Exclusion Criteria
6. Have type 1 diabetes mellitus (T1DM) or T2DM, history of ketoacidosis, or hyperosmolar
state/coma
7. Have laboratory evidence diagnostic of diabetes mellitus during screening, including 1 or
more of: HbA1c ≥6.5% (≥48 mmol/mol), FG ≥126 mg/dL (≥7.0 mmol/L), random glucose
or 2-hour glucose measurement from a 2-hour OGTT ≥200 mg/dL (≥11.1 mmol/L)
8. Have a self-reported change in body weight >5 kg within 3 months prior to screening
9. Have a prior or planned surgical treatment for obesity (excluding liposuction or
abdominoplasty if performed >1 year prior to screening)
10. Have or plan to have endoscopic and/or device-based therapy for obesity or have had device
removal within the last 6 months (for example, mucosal ablation, gastric artery
embolization, intragastric balloon and duodenal-jejunal bypass sleeve)
11. Have renal impairment measured as estimated glomerular filtration rate (eGFR)
<30 mL/min/1.73 m2
, calculated by Chronic Kidney Disease-Epidemiology as determined
by central laboratory during screening
12. Have a known clinically significant gastric emptying abnormality (for example, severe
diabetic gastroparesis or gastric outlet obstruction) or chronically take drugs that directly
affect GI motility
13. Have had a history of chronic or acute pancreatitis
14. Have thyroid-stimulating hormone (TSH) outside of the range of 0.4 to 6.0 mIU/L at
screening visit
Note: Patients receiving treatment for hypothyroidism may be included, provided their
thyroid hormone replacement dose has been stable for at least 3 months.
Note: TSH values above the normal range can, in some patients, suggest subclinical
hypothyroidism. If, in the investigator’s opinion, the participant has subclinical
hypothyroidism and may require initiation of thyroid hormone replacement during the
course of the study, the patient should be excluded from the study.
15. Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome)
or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4
Receptor deficiency or Prader Willi Syndrome)
16. Have a history of significant active or unstable Major Depressive Disorder (MDD) or other
severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or other serious
mood or anxiety disorder) within the last 2 years
Note: Patients with MDD or generalized anxiety disorder whose disease state is considered
stable and expected to remain stable throughout the course of the study, in the opinion of the
investigator, may be considered for inclusion if they are not on excluded medications
17. Have any lifetime history of a suicide attempt
18. Have a Patient Health Questionnaire-9 (PHQ-9) score of 15 or more at Visit 1 or 3, prior to
randomization
19. On the C-SSRS at Visits 1, 2, or 3, prior to randomization:
a “yes” answer to either Question 4 (Active Suicidal Ideation with Some Intent to
Act, Without Specific Plan)
or
a “yes” answer to Question 5 (Active Suicidal Ideation with Specific Plan and
Intent) on the "Suicidal Ideation" portion of the C-SSRS
or
a “yes” answer to any of the suicide-related behaviors (Actual Attempt, Interrupted
Attempt, Aborted Attempt, Preparatory Act or Behavior) on the "Suicidal Behavior"
portion of the C-SSRS
and
the ideation or behavior occurred within the past month
20. Have uncontrolled hypertension (SBP above or equal to 160 mmHg and/or diastolic blood
pressure above or equal to 100 mmHg)
21. Have any of the following cardiovascular conditions within 3 months prior to
randomization: acute myocardial infarction (MI), cerebrovascular accident (stroke),
unstable angina, or hospitalization due to congestive heart failure (CHF)
22. Have NYHA Functional Classification IV CHF
23. Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than
nonalcoholic fatty liver disease, or any of the following, as determined by the central
laboratory during screening:
alanine aminotransferase (ALT) level >3.0X the upper limit of normal
(ULN) for the reference range
or
alkaline phosphatase (ALP) level >1.5X the ULN for the reference range
or
total bilirubin (TBL) level >1.2X the ULN for the reference range
(except for cases of known Gilbert’s Syndrome)
Note: Participants with nonalcoholic fatty liver disease are eligible to participate in this trial
if their ALT level is ≤3.0X the ULN for the reference range
24. Have a calcitonin level (at Visit 1) of:
o ≥20 ng/L at Visit 1, if eGFR ≥60 mL/min/1.73 m
2
o ≥35 ng/L at Visit 1, if eGFR <60 mL/min/1.73 m
2
25. Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple
Endocrine Neoplasia (MEN) Syndrome type 2
26. Have a history of an active or untreated malignancy or are in remission from a clinically
significant malignancy (other than basal- or squamous-cell skin cancer, in situ carcinomas of
the cervix, or in situ prostate cancer) for less than 5 years
27. Have any other condition not listed in this section (for example, hypersensitivity or
intolerance) that is a contraindication to GLP-1R agonists
28. Have a history of any other condition (such as known drug or alcohol abuse, diagnosed
eating disorder, or other psychiatric disorder) that, in the opinion of the investigator, may
preclude the participant from following and completing the protocol
29. Have history of use of marijuana within 3 months of enrollment and unwillingness to
abstain from marijuana use during the trial. Participants should also refrain from use of
cannabidiol oil for the duration of the study
30. Have had a transplanted organ (corneal transplants [keratoplasty] allowed) or awaiting an
organ transplant
31. Have any hematological condition that may interfere with HbA1c measurement (for
example, hemolytic anemias, sickle cell disease)
32. Are receiving or have received within 3 months prior to screening chronic (>2 weeks or
14 days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intraarticular, or inhaled preparations) or have evidence of a significant, active autoimmune
abnormality (for example, lupus or rheumatoid arthritis) that has required (within the last
3 months) or is likely to require, in the opinion of the investigator, concurrent treatment with
systemic glucocorticoids (excluding topical, intraocular, intranasal, intra-articular or inhaled
preparations) in the next 12 months
33. Have current or history of (within 3 months prior to randomization) treatment with
medications that may cause significant weight gain, including but not limited to: tricyclic
antidepressants, atypical antipsychotic and mood stabilizers for example:
imipramine
amitriptyline
mirtazapine
paroxetine
phenelzine
chlorpromazine
thioridazine
clozapine
olanzapine
valproic acid and its derivatives
lithium
Note: Selective serotonin reuptake inhibitors other than paroxetine are permitted.
34. Have taken within 3 months prior to randomization, medications (prescribed or over-thecounter) or alternative remedies intended to promote weight loss. Examples include, but
are not limited to
Saxenda® (liraglutide 3.0 mg)
Xenical®/Alli® (orlistat)
Meridia® (sibutramine)
Acutrim® (phenylpropanolamine)
Sanorex® (mazindol)
Adipex® (phentermine)
BELVIQ® (lorcaserin)
Qsymia® (phentermine/topiramate combination)
Contrave® (naltrexone/bupropion)
Note: Use of metformin or any other glucose-lowering medication, whether prescribed
for polycystic ovary syndrome or diabetes prevention is not permitted.
35. Have started implantable or injectable contraceptives (such as Depo-Provera®) within
18 months prior to screening
36. Are currently enrolled in any other clinical study involving an investigational product (IP) or
any other type of medical research judged not to be scientifically or medically compatible
with this study
37. Within the last 30 days, have participated in a clinical study and received treatment, whether
active or placebo. If the study involved an IP, 5 half-lives or 30 days, whichever is longer,
should have passed
state/coma
7. Have laboratory evidence diagnostic of diabetes mellitus during screening, including 1 or
more of: HbA1c ≥6.5% (≥48 mmol/mol), FG ≥126 mg/dL (≥7.0 mmol/L), random glucose
or 2-hour glucose measurement from a 2-hour OGTT ≥200 mg/dL (≥11.1 mmol/L)
8. Have a self-reported change in body weight >5 kg within 3 months prior to screening
9. Have a prior or planned surgical treatment for obesity (excluding liposuction or
abdominoplasty if performed >1 year prior to screening)
10. Have or plan to have endoscopic and/or device-based therapy for obesity or have had device
removal within the last 6 months (for example, mucosal ablation, gastric artery
embolization, intragastric balloon and duodenal-jejunal bypass sleeve)
11. Have renal impairment measured as estimated glomerular filtration rate (eGFR)
<30 mL/min/1.73 m2
, calculated by Chronic Kidney Disease-Epidemiology as determined
by central laboratory during screening
12. Have a known clinically significant gastric emptying abnormality (for example, severe
diabetic gastroparesis or gastric outlet obstruction) or chronically take drugs that directly
affect GI motility
13. Have had a history of chronic or acute pancreatitis
14. Have thyroid-stimulating hormone (TSH) outside of the range of 0.4 to 6.0 mIU/L at
screening visit
Note: Patients receiving treatment for hypothyroidism may be included, provided their
thyroid hormone replacement dose has been stable for at least 3 months.
Note: TSH values above the normal range can, in some patients, suggest subclinical
hypothyroidism. If, in the investigator’s opinion, the participant has subclinical
hypothyroidism and may require initiation of thyroid hormone replacement during the
course of the study, the patient should be excluded from the study.
15. Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome)
or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4
Receptor deficiency or Prader Willi Syndrome)
16. Have a history of significant active or unstable Major Depressive Disorder (MDD) or other
severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or other serious
mood or anxiety disorder) within the last 2 years
Note: Patients with MDD or generalized anxiety disorder whose disease state is considered
stable and expected to remain stable throughout the course of the study, in the opinion of the
investigator, may be considered for inclusion if they are not on excluded medications
17. Have any lifetime history of a suicide attempt
18. Have a Patient Health Questionnaire-9 (PHQ-9) score of 15 or more at Visit 1 or 3, prior to
randomization
19. On the C-SSRS at Visits 1, 2, or 3, prior to randomization:
a “yes” answer to either Question 4 (Active Suicidal Ideation with Some Intent to
Act, Without Specific Plan)
or
a “yes” answer to Question 5 (Active Suicidal Ideation with Specific Plan and
Intent) on the "Suicidal Ideation" portion of the C-SSRS
or
a “yes” answer to any of the suicide-related behaviors (Actual Attempt, Interrupted
Attempt, Aborted Attempt, Preparatory Act or Behavior) on the "Suicidal Behavior"
portion of the C-SSRS
and
the ideation or behavior occurred within the past month
20. Have uncontrolled hypertension (SBP above or equal to 160 mmHg and/or diastolic blood
pressure above or equal to 100 mmHg)
21. Have any of the following cardiovascular conditions within 3 months prior to
randomization: acute myocardial infarction (MI), cerebrovascular accident (stroke),
unstable angina, or hospitalization due to congestive heart failure (CHF)
22. Have NYHA Functional Classification IV CHF
23. Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than
nonalcoholic fatty liver disease, or any of the following, as determined by the central
laboratory during screening:
alanine aminotransferase (ALT) level >3.0X the upper limit of normal
(ULN) for the reference range
or
alkaline phosphatase (ALP) level >1.5X the ULN for the reference range
or
total bilirubin (TBL) level >1.2X the ULN for the reference range
(except for cases of known Gilbert’s Syndrome)
Note: Participants with nonalcoholic fatty liver disease are eligible to participate in this trial
if their ALT level is ≤3.0X the ULN for the reference range
24. Have a calcitonin level (at Visit 1) of:
o ≥20 ng/L at Visit 1, if eGFR ≥60 mL/min/1.73 m
2
o ≥35 ng/L at Visit 1, if eGFR <60 mL/min/1.73 m
2
25. Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple
Endocrine Neoplasia (MEN) Syndrome type 2
26. Have a history of an active or untreated malignancy or are in remission from a clinically
significant malignancy (other than basal- or squamous-cell skin cancer, in situ carcinomas of
the cervix, or in situ prostate cancer) for less than 5 years
27. Have any other condition not listed in this section (for example, hypersensitivity or
intolerance) that is a contraindication to GLP-1R agonists
28. Have a history of any other condition (such as known drug or alcohol abuse, diagnosed
eating disorder, or other psychiatric disorder) that, in the opinion of the investigator, may
preclude the participant from following and completing the protocol
29. Have history of use of marijuana within 3 months of enrollment and unwillingness to
abstain from marijuana use during the trial. Participants should also refrain from use of
cannabidiol oil for the duration of the study
30. Have had a transplanted organ (corneal transplants [keratoplasty] allowed) or awaiting an
organ transplant
31. Have any hematological condition that may interfere with HbA1c measurement (for
example, hemolytic anemias, sickle cell disease)
32. Are receiving or have received within 3 months prior to screening chronic (>2 weeks or
14 days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intraarticular, or inhaled preparations) or have evidence of a significant, active autoimmune
abnormality (for example, lupus or rheumatoid arthritis) that has required (within the last
3 months) or is likely to require, in the opinion of the investigator, concurrent treatment with
systemic glucocorticoids (excluding topical, intraocular, intranasal, intra-articular or inhaled
preparations) in the next 12 months
33. Have current or history of (within 3 months prior to randomization) treatment with
medications that may cause significant weight gain, including but not limited to: tricyclic
antidepressants, atypical antipsychotic and mood stabilizers for example:
imipramine
amitriptyline
mirtazapine
paroxetine
phenelzine
chlorpromazine
thioridazine
clozapine
olanzapine
valproic acid and its derivatives
lithium
Note: Selective serotonin reuptake inhibitors other than paroxetine are permitted.
34. Have taken within 3 months prior to randomization, medications (prescribed or over-thecounter) or alternative remedies intended to promote weight loss. Examples include, but
are not limited to
Saxenda® (liraglutide 3.0 mg)
Xenical®/Alli® (orlistat)
Meridia® (sibutramine)
Acutrim® (phenylpropanolamine)
Sanorex® (mazindol)
Adipex® (phentermine)
BELVIQ® (lorcaserin)
Qsymia® (phentermine/topiramate combination)
Contrave® (naltrexone/bupropion)
Note: Use of metformin or any other glucose-lowering medication, whether prescribed
for polycystic ovary syndrome or diabetes prevention is not permitted.
35. Have started implantable or injectable contraceptives (such as Depo-Provera®) within
18 months prior to screening
36. Are currently enrolled in any other clinical study involving an investigational product (IP) or
any other type of medical research judged not to be scientifically or medically compatible
with this study
37. Within the last 30 days, have participated in a clinical study and received treatment, whether
active or placebo. If the study involved an IP, 5 half-lives or 30 days, whichever is longer,
should have passed
The Estimated Number of Participants
-
Taiwan
80 participants
-
Global
2400 participants
