Phase 1/1b Study of TLC-6740 in Healthy Subjects and Subjects With Obesity, With or Without Diabetes
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorOrsoBio, Inc
About this trial
The phase 1 portion of the study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TLC-6740 after single- and multiple-ascending doses in healthy subjects. The phase 1b portion of the study is designed to assess the safety, tolerability, and PK of TLC-6740 in subjects with obesity, with or without type 2 diabetes mellitus.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Non-smoking, healthy male or female subject between 18 and 55 years of age, inclusive (Parts A-E); male or female subject between 18 and 70 years of age, inclusive (Parts F, G)
Body mass index (BMI) from 19 to 35 kg/m2, inclusive (Parts A-E); BMI ≥ 30 kg/m2 and ≤ 50 kg/m2 (Parts F, G)
Estimated glomerular filtration rate (eGFR) ≥ 80 mL/min (Parts A-E); eGFR ≥ 60 mL/min/1.73m2 or eGFR ≥ 45 mL/min/1.73m2, depending on cohort (Parts F, G)
ALT/AST/ALP ≤ 1 x ULN (Parts A-E); ALT/AST < 3 x ULN, ALP < 1.5 x ULN (Parts F, G)
Disqualifiers
Pregnant or lactating subjects
Unstable type 2 diabetes (as defined as: HbA1c > 10.0%; treatment with insulin and/or pioglitazone within 90 days prior to Screening; any history of diabetic ketoacidosis, hyperosmolar state, and/or acutely decompensated blood glucose control; hypoglycemia unawareness, hospitalization due to hypoglycemia, or history of severe hypoglycemia [requiring outside assistance to regain normal neurologic status]) (Part F)
History of type 2 diabetes diagnosed prior
Medical history of type 1 diabetes or latent autoimmune diabetes of adults (LADA)
Trial design
Design model
Sequential
Treatments tested in this trial
TLC-6740 Oral Solution
DrugOral solution of TLC-6740
Placebo Oral Solution
Other interventionPlacebo-to-match oral solution TLC-6740
TLC-6740 Tablet
DrugTablet formulation of TLC-6740
Drug Metabolizing Enzyme
DrugOral dose of omeprazole, voriconazole, itraconazole, or rifampicin
Tirzepatide
DrugSubcutaneous injection of tirzepatide
Placebo Tablet
Other interventionPlacebo-to-match tablet formulation of TLC-6740
Treatment groups
564 Participants
are divided into 5 treatment groupsGroup A: Oral SolutionExperimental treatment 2 interventions
Group B: TabletExperimental treatment 2 interventions
Group C: Drug Metabolizing EnzymeExperimental treatment 2 interventions
Group D: TLC-6740 + TirzepatideExperimental treatment 2 interventions
Group E: Placebo + TirzepatideExperimental treatment 0 interventions
Trial outcomes
Primary outcomes
1
Incidence of TLC-6740 treatment-emergent adverse events
Adverse events (AEs) - severity of the AEs will be graded using the Common Terminology Criteria for AE (CTCAE) (v5.0). The relationship between AEs and the study drug will be indicated as related or not related.
Time frame
Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 168 (Parts F, G) of the study2
PK of TLC-6740 AUC
Area under the concentration-time curve
Time frame
Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 168 (Parts F, G) of the study3
PK of TLC-6740 Cmax
Maximum plasma concentration
Time frame
Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 168 (Parts F, G) of the study4
PK of TLC-6740 tmax
Time to reach Cmax
Time frame
Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 168 (Parts F, G) of the studySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov