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

Recruiting Phase 1 Interventional Study
Healthy Subjects Obesity Type 2 Diabetes
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
564 (estimated)
Sponsor
OrsoBio, Inc · Industry
Who this trial is looking for

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.

Are You a Good Fit for This Trial?

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 Eligibility
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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 (P…
Contacts

Ryan Huss, MD

650-382-2225

Clinicaltrials_Inquires@orsobio.com

CONTACT