Ph 2a Study of HU6 on Energy Metabolism, Muscle and Liver Substrate Metabolism, and Mitochondrial Function in Subjects Who Are Overweight or Obese With Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-17

Study Completion Date

2025-03-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Diabete Type 2 Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active Treatment HU6

Subjects who are randomized to active study drug will receive 450mg of HU6 for 14 day and then 600mg of HU6 for 168 days. N = 24

Group Type EXPERIMENTAL

HU6

Intervention Type DRUG

HU6 is being evaluated for its effect on Energy Metabolism, Muscle and Liver Substrate Metabolism, and Mitochondrial Function

Placebo

Placebo Comparator is non-active study drug. N = 24

Group Type PLACEBO_COMPARATOR

HU6

Intervention Type DRUG

HU6 is being evaluated for its effect on Energy Metabolism, Muscle and Liver Substrate Metabolism, and Mitochondrial Function

Interventions

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HU6

HU6 is being evaluated for its effect on Energy Metabolism, Muscle and Liver Substrate Metabolism, and Mitochondrial Function

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Able to understand the procedures and requirements of the study and provide written informed consent and authorization for protected health information disclosure.
2. Willing and able to comply with the requirements of the study protocol.
3. Male or female 18 to 70 years of age, inclusive, at time of informed consent.
4. Body mass index (BMI) \>28.0 kg/m2 and able to fit into the MRI machine.
5. Subject has T2D meeting all of the following criteria:

Exclusion Criteria

1. Body weight \>450 pounds.
2. Subject-reported history of weight gain or loss \>5% in 3 months prior to screening.
3. The subject participates in programmed exercise \>3 hours per week.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No