Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT06104358
Brief Summary:
This is a randomized, double-blind, placebo-controlled parallel group study of HU6 and placebo in subjects who are overweight or obese with T2D.
The study will be conducted in 4 stages.
Detailed Description:
This is a randomized, double-blind, placebo-controlled parallel group study of HU6 and placebo in subjects who are overweight or obese with T2D.
The study will be conducted in 4 stages (Figure 1).
* Stage 1: (screening) is conducted over a 29-day window (Day -48 to Day -20). Subjects who meet all of the eligibility criteria may proceed Stages 2 to 4 of the study.
* Stage 2 (baseline \[pre-randomization\]) is conducted over a 19-day period prior to randomization and includes a 13-day run-in and the first 6-day inpatient assessment period. At the end of Stage 2, subjects will be randomized 1:1 to HU6 or placebo.
* Stage 3 (double-blind dosing) is conducted after randomization. Day 1 is the first dose of double-blind study drug, and dosing continues over an approximate 26-week period. During this time, there will be study visits for safety, PK, and PD. Stage 3 of the study concludes with a 3-day run-in followed by the second 6-day inpatient assessment period.
* Stage 4 (washout) is conducted after dosing has ended and includes an approximate 4-week washout duration including a 3-day run-in followed by the third inpatient assessment period (3-day duration). The last day of the 3-day inpatient stay is the end-of-study. (Note that there will be a separate early termination visit for any subject who prematurely discontinues from the study
Study:
NCT06104358
Study Brief:
Protocol Section:
NCT06104358