Trials / Unknown
UnknownNCT05532020
An Open-Label Study of Diazoxide Choline in Patients With Genetic Obesities
An Open-Label Study to Assess the Preliminary Efficacy and Safety of DCCR (Diazoxide Choline) Extended-Release Tablets in Patients With Genetic Obesities
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Soleno Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 5 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Patients aged 5 years and older with obesity due to SH2B1 deficiency obesity, obesity associated with PCSK1 mutation (rs6232 variant), or SIM1 deficiency obesity will be enrolled into this phase 2 open-label clinical trial at a single clinical center in North America. All eligible participants will receive DCCR (diazoxide choline) extended-release tablets for 1 year.
Conditions
- SH2B1 Deficiency Obesity
- Obesity Associated With PCSK1 Mutation (rs6232 Variant)
- SIM1 Deficiency Obesity
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-01-01
- Primary completion
- 2024-01-01
- Completion
- 2024-03-01
- First posted
- 2022-09-08
- Last updated
- 2022-09-08
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05532020. Inclusion in this directory is not an endorsement.