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An Open-Label Study of Diazoxide Choline in Patients With Genetic Obesities

NCT05532020 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-09-08

No results posted yet for this study

Summary

This is a phase 2 open-label, one-arm, clinical study to evaluate the efficacy and safety of DCCR (diazoxide choline) extended-release tablets over 1 year of treatment, in patients with genetic obesities.

Conditions

  • SH2B1 Deficiency Obesity
  • Obesity Associated With PCSK1 Mutation (rs6232 Variant)
  • SIM1 Deficiency Obesity

Interventions

DRUG

DCCR (diazoxide choline) extended-release tablets

All participants will be titrated over a four week period to the maintenance dose. Participants will take DCCR daily for up to 52 weeks.

Sponsors & Collaborators

  • Soleno Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2024-01-31
Completion
2024-03-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05532020 on ClinicalTrials.gov