A Phase 1b/2a Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate Efficacy, Safety, Tolerability and the Pharmacokinetics of GL0034 (Utreglutide) in the Treatment of Non-alcoholic Fatty Liver Disease

Phase 1

Recruiting

• Conditions: on-alcoholic Fatty Liver Disease (NAFLD); Non-alcoholic Fatty Liver Disease (NAFLD); Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12624000322538
• Lead Sponsor: International Sponsor: Sun Pharmaceutical Industries Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-25
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 48

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) Inte

Study & Design

• Study Type: Interventional
• Study Design: Not specified