Actively Recruiting
Phase 1/1b Study of TLC-6740 in Healthy Subjects and Subjects With Obesity, With or Without Diabetes
Led by OrsoBio, Inc · Updated on 2025-12-18
564
Participants Needed
4
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 1/1b Study of TLC-6740 in Healthy Subjects and Subjects With Obesity, With or Without Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Non-smoking, healthy male or female between 18 and 55 years old (Parts A-E)
- Male or female between 18 and 70 years old (Parts F, G)
- Body mass index (BMI) 19 to 35 kg/m2 (Parts A-E)
- Body mass index (BMI) 30 to 50 kg/m2 (Parts F, G)
- Estimated glomerular filtration rate (eGFR) 80 mL/min or higher (Parts A-E)
- Estimated glomerular filtration rate (eGFR) 60 mL/min/1.73m2 or higher or 45 mL/min/1.73m2 or higher depending on cohort (Parts F, G)
- Liver enzymes ALT, AST, ALP within normal limits or specified multiples of upper limits (Parts A-E and F, G)
- Normal 12-lead electrocardiogram (ECG) or clinically insignificant abnormalities
- Negative pregnancy test for females of childbearing potential
- Agreement to use specified contraception if sexually active
- Good health based on medical history and physical exam including vital signs
You will not qualify if you...
- Pregnant or breastfeeding
- Unstable type 2 diabetes (high HbA1c, recent insulin/pioglitazone use, history of diabetic ketoacidosis or severe hypoglycemia) (Part F)
- Prior diagnosis of type 2 diabetes
- History of type 1 diabetes or latent autoimmune diabetes of adults (LADA)
- Obesity caused by other endocrine disorders or genetic syndromes
- Known serious allergy to tirzepatide (Part G)
- Serious or active medical or psychiatric illness interfering with study compliance
- Use of investigational drug within 30 days or 5 half-lives before dosing
- Current alcohol or substance abuse affecting compliance or safety
- Positive test for HIV, hepatitis B or C
- History of drug sensitivity or allergy such as anaphylaxis or liver toxicity
- History or presence of significant cardiovascular diseases or abnormalities
- Syncope, palpitations, unexplained dizziness
- Implanted defibrillator or pacemaker
- History of liver disease including autoimmune or drug-induced conditions
- Severe peptic ulcer disease or gastric acid hypersecretory conditions
- Prior medical or surgical treatment permanently affecting intestinal absorption
- COVID-19 vaccination within 14 days before admission
- Other protocol-specific criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
OrsoBio Auckland Research Site 1
Auckland, New Zealand
Actively Recruiting
2
OrsoBio Auckland Research Site 2
Auckland, New Zealand
Actively Recruiting
3
OrsoBio Auckland Research Site 3
Auckland, New Zealand
Actively Recruiting
4
OrsoBio Research Site
Christchurch, New Zealand
Actively Recruiting
Research Team
R
Ryan Huss, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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