TLC-6740 for Obesity and Type 2 Diabetes
Phase 1/1b Study of TLC-6740 in Healthy Subjects and Subjects With Obesity, With or Without Diabetes
- Age
- 18 – 70
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 564 (estimated)
- Sponsor
- OrsoBio, Inc · Industry
This trial is looking for healthy adults or individuals with obesity, with or without type 2 diabetes. Participants will take a medication called TLC-6740 to help researchers learn more about its safety and effects.
You may be able to join if
- I am between 18 and 55 years old, or between 18 and 70 years old for certain parts.
- I have a body mass index (BMI) between 19 and 35, or a BMI between 30 and 50 for certain parts.
- My kidney function (eGFR) is at least 80 mL/min, or at least 60 or 45 mL/min depending on the part I'm in.
- I have normal liver enzyme levels or levels that are mildly elevated.
- I have a normal ECG or one with minor issues that my doctor says are not concerning.
- I am in good health based on my medical history and a physical exam.
- I am female and not pregnant, or I have a negative pregnancy test.
- I agree to use contraception if I am of childbearing potential.
You may not be able to join if
- I am pregnant or breastfeeding.
- I have unstable type 2 diabetes or require certain diabetes medications.
- I have a history of type 1 diabetes or other specific types of diabetes.
- I have a serious allergy to tirzepatide or its ingredients.
- I have a serious medical or psychiatric condition that affects my participation.
- I have had any investigational drug in the last 30 days.
- I have a history of serious heart problems.
- I have had significant liver disease.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your EligibilityThe 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.
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