None listed
Conditions
Brief summary
The purpose of this study is to test the safety and effectiveness of the investigational medication in the threatment of Non-alcoholic Fatty Liver Disease (NAFLD) in obese adults. This is a randomized, double-blind, placebo controlled and parallel group study of GL0034 (Utreglutide) for the treatment of (NAFLD). Approximately 48 participants will be randomly assigned to receive GL0034/Placebo in a ratio of 3:1. GL0034/Placebo is administered weekly as a subcutaneous injection for a period of 13 weeks, The dose will be increased gradually for a period of 10 weeks (called the Dose Titration Period) and then will remain at a fixed dose for 3 weeks (called the Final Dose Period)
Interventions
This is a randomized, double-blind, placebo controlled and parallel group study of GL0034 (Utreglutide) for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD).
Approximately 48 participants will be randomly assigned to receive GL0034/Placebo in a ratio of 3:1. GL0034/Placebo is administered weekly as a subcutaneous injection given by a registered nurse for a period of 13 weeks, The dose will be increased gradually starting at 0.4mg for a period of 2 weeks, 0.8mg for 4 weeks, 1.6mg for
This is a randomized, double-blind, placebo controlled and parallel group study of GL0034 (Utreglutide) for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD). Approximately 48 participants will be randomly assigned to receive GL0034/Placebo in a ratio of 3:1. GL0034/Placebo is administered weekly as a subcutaneous injection given by a registered nurse for a period of 13 weeks, The dose will be increased gradually starting at 0.4mg for a period of 2 weeks, 0.8mg for 4 weeks, 1.6mg for 4 weeks (called the Dose Titration Period) and then will remain at a fixed dose of 2.4mg for 3 weeks (called the Final Dose Period). Vital signs including temperature, blood pressure and weight will be regularly reviewed in addition to the collection of blood tests every 2-4 weeks to assess overall health and any study drug effects. Blood samples will also be collected prior to dosing at visit weeks 1, 3, 5, 6, 9, 10, 12, 13 and 17 to measure the levels of GL0034 in the blood. If you are eligible for the main study, you may consent to the optional sub-study. The optional sub-study includes additional samples that measure the level of GL0034 in the blood will be collected daily over a period of 5 days at visits week 3, week 7, week 11 and week 13. Blood samples will also be collected once only at week 14, week 15 and week 16.
Sponsors
International Sponsor: Sun Pharmaceutical Industries Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1) Male or female aged 18 to 70, inclusive at the time of Screen 1. 2) Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol, prior to any study procedures at Screen 1. 3) BMI greater than or equal to 30.0 kg/m2 with weight not exceeding the maximum capacity of the local MRI machine or facility infrastructure as per standard practices inclusive at the time of Screen 1, Screen 2, and Day 1. 4) Controlled attenuated parameter (CAP) greater than or equal to 306 dB/m via fasting FibroScan® assessment at Screen 1. 5) Liver fat content greater than or equal to 10%, as assessed by MRI-PDFF at Screen 2
Exclusion criteria
1) History or previous diagnosis of, or currently experiencing any medical condition that may increase the risk associated with study participation, limit the participants ability to complete the study, or to comply with protocol requirements, or to absorb the IP, or interfere with the interpretation of study results, including: -Non-NAFLD chronic liver disease. -Proliferative retinopathy or maculopathy requiring acute treatment -Current diagnosis of a mental health disorder, as defined by DSM-5 with active suicidal ideation. - Previous clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions. -Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, or manifest hypo- or hyperthyroidism. - Pancreatitis (acute or chronic). -Any other clinically significant unstable medical condition, or laboratory abnormality which, in the judgment of the investigator, would make the participant inappropriate for entry into this study. Note: Participants with diet-controlled type-2 diabetes (T2D) who have an HbA1c less than or equal to 8 are permitted in this study. 2) Participants with clinically relevant laboratory abnormalities, as assessed by local laboratory, that in the investigator’s opinion could impact participant safety. 3) History of regular and excessive alcohol consumption exceeding 14 standard drinks/week for female participants or 21 drinks/week for male participants (1 drink is equivalent to 150 mL of wine, 360 mL of beer or 45 mL liquor) within the previous 6 months of informed consent. 4) Evidence or previous diagnosis of the following infections: -Hepatitis B virus, -Hepatitis C virus (HCV) -Human immunodeficiency virus (HIV) -Acute (current and active) Coronavirus disease 2019 (COVID-19) infection. 5) Unstable or poorly controlled hypertension that in the investigator’s opinion would impact participant safety. 6) Supine 12-lead ECG (average) demonstrating a QTcF interval greater than 450 msec or a QRS interval greater than 120 msec, that in the investigator’s opinion could impact participant safety. 7) Estimated GFR <60 mL/min/1.73m2 8) Participants meeting criteria for contraindication for MRI, including: -History of severe claustrophobia impacting ability to perform MRI during the study. -Current implants, devices, objects, or markings within or on the body, containing metal or material not compatible with MRI. -Unable to lie still or maintain a breath hold for the required period to acquire MRI images (15 to 20 seconds). -Abdominal girth or weight exceeding the maximum capacity of the local MRI system. 9) Participants taking any prohibited concomitant medication(s) or those unable to switch to permitted concomitant medication(s) -Systemic treatment with vitamin E in the period from 90 days prior to Screen 2 (topical use is allowed). - Treatment with drugs with a potential effect on steatosis; corticosteroids (topical and inhaled are allowed), methotrexate, tamoxifen, valproic acid, amiodarone or tetracycline in the period from 28 days prior to Screen 2. - Treatment with orlistat, zonisamide, topiramate, phentermine, lorcaserin, bupropion and naltrexone alone or in combination, or any other medication that could promote weight loss in the opinion of the investigator in the period from 28 days prior to Screen 2. 10) Intentional weight loss (greater than or equal to 5%) within 1 month prior to Screen. . 11) Whole blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to Screen 1 or during the study until the EOS visit. 12) Treatment with an investigational drug within 180 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational drug. 13) Treatment with GLP-1 analogues or GLP-1 receptor (GLP-1R) analogues, or sodium-glucose cotransporter-2 inhibitors in the period from 90 days prior to Screen 2. 14) History of hypersensitivity reaction to GLP-1 analogues and GLP-1R analogues. 15) Any individuals who are directly involved in the conduct of the study, or family members of these individuals. 16) Participants unwilling to adhere to the following lifestyle restriction during the study (from randomization until EOS Visit): -Abstain from taking recreational drugs in the period of 30 days prior to first dose. -Abstain from alcohol intake 24 hours prior to each IP product administration. -8-hour overnight fast (except water) prior to any fasting blood collections. -Abstain from caffeine-containing products for 2 hours prior to ECG and vital sign measurements. -Abstain from the use of tobacco or nicotine containing products for 24 hours prior to IP administration. -Abstain from strenuous exercise (eg, heavy lifting, weight training) for at least 24 hours prior to each blood collection for clinical laboratory tests.
Outcome results
None listed