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

Rivus Pharmaceuticals

Status and phase: Withdrawn; Phase 2

Conditions: Obesity; Diabete Type 2

Treatments: Drug: HU6

Study type: Interventional

Funder types: Industry

Identifiers

NCT06104358

RIV-HU6-204

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Active Treatment HU6

Experimental group

Description:

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

Treatment:

Drug: HU6

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: HU6