A 20-week, double-blind, randomized, placebo-controlled, parallel-group trial to assess the safety and efficacy of HM11260C on body weight in obese subjects without diabetes

1. Aged >= 18 and < 65 years at screening
2. BMI >= 30 kg/m2 or >= 27 kg/m2, with treated or untreated co-morbidity(ies) (e.g., hypertriglyceridemia, dyslipidemia, hypertension, glucose intolerance, and sleep apnea), at screening.
3. Stable body weight (less than 5% change) for at least 3 months prior to screening
4. FPG < 126 mg/dL (7 mmol/L)
5. Considered to be in stable health, as determined by:
a) physical examination;
b) a medical history indicating either no clinically significant abnormalities or stable co-morbid condition(s);
c) vital signs within normal ranges or if outside of the normal range are not deemed clinically significant in the opinion of the Investigator;
d) pre-study clinical laboratory findings within normal range, or if outside of the normal range, not deemed clinically significant in the opinion of the investigator; and
e) a 12-lead electrocardiogram (ECG) showing no active ischemia
6. Not undergoing or in need of treatment for significant chronic disease, with the exception of stable (at least 3 months) treatment for hypertension, hypertriglyceridemia, and dyslipidemia, which is permitted
7.Female subjects of child-bearing potential must test negative for serum pregnancy at screening and by urine dipstick prior to dosing on the first day of dosing, and agree to use a highly effective method of birth control throughout the study and for at least 3 months after the last dose of study medication. Child bearing potential is defined as women who have not been surgically sterilized for 6 weeks prior to screening or are post menopausal <= 1 year. For women who are surgically sterilized or post-menopausal (> 1 year prior to the screening visit), the site will make an effort to retrieve medical records to document sterility. However, the absence of records will not exclude the subject. In the event that medical records cannot be obtained, serum and urine pregnancy testing will be conducted. Post-menopausal status will be confirmed through testing of follicle stimulating hormone (FSH) levels >= 40 IU/mL at screening.
A highly effective method of birth control is considered to be 1 of the following:
a)An oral or implanted hormonal method of contraception (if it has been used for >= 3 months prior to study drug administration) while also using a barrier method (i.e., a condom or a diaphragm);
b) A hormone or copper intrauterine device if it has been in place for >= 3 months prior to study drug administration (subjects using a nonhormonal or copper intrauterine device should also use a barrier method [i.e., a condom or a diaphragm]);
c) A vasectomised partner;
d) Total abstinence is acceptable; however, the subject must use a highly effective method of contraception if the subject subsequently decides not to abstain.
8. Male subjects whose partners are female of child bearing potential must be surgically sterilized (e.g., vasectomy) for at least 3 months prior to screening or agree to practice reliable birth control methods (condom and spermicide) during the conduct of the study and for at least 3 months after the last dose of study medication.
9. Ability and willingness to comply with all protocol procedures (e.g., correct handling of investigational product, compliance with visit schedule and dietary advice, and complete trial-related questionnaires)
10.Written informed consent must be obtained before any study-related assessment is performed.

1. Prior participation in any study of HM11260C. Subjects who signed an informed consent for a prior HM11260C study may be eligible provided they were not randomized in the prior study, and there were no clinically significant findings from the previous study that would exclude them from the current study
2. Pregnant or nursing (lactating) women
3. BMI > 42 kg/m2
4.Drug induced obesity
5.Diabetes mellitus (type 1, 2, or other)
6.HbA1c > 6.5%
7. Previous surgical treatment for obesity (e.g., gastric bypass, ileal bypass, gastric banding) or anticipation of surgery during the study period that may interfere with completion or compliance with the protocol, or planned elective hospitalizations
8. Any known history of severe gastrointestinal (GI) disease or intolerance (prolonged nausea and vomiting, chronic diarrhea during the previous 6 months), gastric emptying abnormality, or inflammatory bowel disease
9. Any previous GI bleeding or ulceration related to the use of non steroidal anti inflammatory drugs (NSAIDs) within 3 months before screening
10. Known history of acute or chronic pancreatitis with presence of raised serum amylase and lipase (>= 3 times the upper limit of normal [ULN]) at screening
11. History of suicide attempts or recent history (within 2 years prior to screening) of major depression, anxiety, or other psychiatric disease requiring treatment with prescription medication including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitor s (SNRIs), antipsychotics, and lithium. Use of SSRIs and SNRIs (including bupropion) for reasons other than active psychiatric indications (e.g., migraine, weight loss, smoking cessation) must meet a 3 month washout period
12. Uncontrolled hypertension, defined as resting blood pressure (BP) * 150/90 mmHg at screening. If elevated, BP will be re-checked on a separate day within the screening period. If elevated on re check, subjects may be rescreened only after being on a stable antihypertensive therapy for 3 months.
13. Has clinically significant abnormalities on 12 lead ECG, as determined by the Investigator, including:
a) Long QT syndrome or prolongation of the QT interval corrected by Fridericia*s formula (QTcF interval > 450 ms for males and > 470 ms for females) at screening and/or on the day of randomization
b) A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
14. History of invasive cardiovascular surgical procedure including, but not limited to, coronary artery bypass grafting, percutaneous coronary intervention(a diagnostic cardiac catheterization does not exclude the subject if no stent placement, angioplasty, or plaque removal occurred during the procedure); or severe heart or circulatory disease, defined as any 1 of the following, within 6 months prior to screening:
a) Current symptomatic heart failure (New York Heart Association [NYHA] class III or IV) (NYHA 1994);
b) A myocardial infarction;
c) Diagnosis of unstable angina requiring medication; or
d) Any transient ischemic attack, cerebral infarct, or cerebral hemorrhage
15. Personal or known family history of medullary thyroid carcinoma (MTC) or a genetic condition that predisposes to MTC (i.e., multiple endocrine neoplasia type 2)
16. Abnormal thyroid stimulating hormone (TSH) laboratory value > 1.5 x ULN (ULN 5 mIU/L) value or abnormal TSH value lower than the normal value (* 0.5 mIU/L). Thyroid hormones are not permitted
17. Fasting TG >= 400 mg/dL. If elevated at screening subjects will re-check fasting TG on a separate day. If the subsequent re-checked value is below 400 mg/dL, the subject will be eligible; if elevated on re-check, the subject will not be eligible). Subjects with fasting TG >= 400 mg/dL and LDL C < 130 mg/dL may be eligible for the study if they have no history of pancreatitis, cerebrovascular accident, transient ischemic stroke, or myocardial infarction, but must be approved through PRA prior to randomization
18. LDL C > 160 mg/dL. Subjects with elevated LDL C at screening may be re-screened > 3 months after initiation or adjustment of lipid lowering treatment, if study enrollment has not been closed. Subjects being treated for dyslipidemia (e.g., fibrates, statins, niacin) must be on the stable dose of prescription/over the counter medication for at least 3 months prior to screening
19. Liver disease, hepatitis, or clinically significant abnormal hepatic parameters suggestive of hepatic impairment (e.g., alanine aminotransferase [ALT] or aspartate aminotransferase (AST) levels > 2.5 x ULN, or total bilirubin > 1.5 x ULN unless the subject has a known history of Gilbert*s syndrome)
20. Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 or has >= 60 mL/min/1.73 m2 and < 90 mL/min/1.73 m2 with urine albumin to urine creatinine ratio > 30 mg/g. The eGFR will be based on the Cockcroft Gault formula at screening. Subject must not have a prior diagnosis of chronic kidney disease
21. Calcitonin levels > 20 pg/mL at screening
22. History of or positive result at screening for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) type 1 or 2 antibody
23. Use of cannabis (recreational or therapeutic) or a positive screen for drugs of abuse (opiates, cocaine, amphetamines, cannabinoids), barbiturates, or benzodiazepines that may potentially jeopardize a subject*s study compliance. Subjects who have been prescribed benzodiazepines, or low dose opiates for chronic conditions, may qualify for the study at the discretion of the investigator
24. A history of alcohol or drug abuse or drug addiction in the previous 12 months. Subjects should limit alcohol use to 14 units per week for women or 21 units per week for men (a unit is 1.5 ounces [44 mL] of 80 proof distilled spirits, 4 ounces [118 mL] of wine, or 12 ounces [355 mL] of 3 5% beer)
25. Heavy smoker (smokes more than 10 cigarettes/day or more than 2 cigars/day)
26. Has lost or donated more than 500 mL of blood within the last 2 months
27. Use of very-low calorie (1,000 kcal/day) liquid weight loss diet within 6 months
28. Known history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
29. Plans to or has had radioactive iodine test with intravenous administration of contrast material (such as intravenous pyelography, intravenous cholangiography, angiography, or computed tomography [CT] with contrast medium) within 3 months of screening
30. Proliferative retinopathy or maculopathy treated within the 6 months before screening or requiring acute treatment
31. History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years before screening. (Any history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed)
32. Severe neuropathy, including but not limited to a) severe autonomic neuropathy (e.g., orthostatic hypotension or treated gastroparesis) or b) severe peripheral neuropathy (e.g., requires medication for neuropathic pain)
33. Atypical sleep patterns (e.g., those working late night or graveyard shifts)
34. Any other condition or clinically significant abnormal findings during the physical examination, assessment of medical history (e.g., previous anaphylactic reactions or recent severe systemic illness, cognitive impairment), or clinical laboratory test results that, in the opinion of the Investigator, would make the subject unsuitable for the study or would put them at additional risk during participation
35. Has taken any of the following medications within the noted time period:
a) Use of a weight control treatment 3 months before screening, including any medication with a labeled reference to weight loss or weight gain and over the counter medications or herbal supplements;
b) Any previous treatment with a glucagon like peptide 1 (GLP-1) analogue, ever, including treatment in a clinical trial;
c) Any previous treatment with anti-diabetic medication;
d) Any drugs that directly affect GI motility, including but not limited to chronic use of anticholinergics, antispasmodics, 5-hydroxytryptamine (5HT3) antagonists, dopamine antagonists or opiates within 2 weeks prior to screening;
e) Treatment with oral or parenteral corticosteroids or topiramate within 3 months prior to screening;
f) Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half lives (of the used drug) of enrollment, whichever is longer