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

NCT05532020 | Unknown Phase 2 FDA Drug

• 1 other identifier: C615
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

SH2B1 deficiency obesity; Obesity associated with PCSK1 mutation; (rs6232 variant); SIM1 deficiency obesity; Genetic obesity

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who achieve at least 5% body weight reduction

  Proportion of participants who achieve at least 5% body weight reduction

  Baseline to Week 26

Secondary Outcomes (4)

• Leptin

  Baseline to Week 26

• Fasting serum insulin

  Baseline to Week 26

• Body fat mass

  Baseline to Week 26

• Feelings of hunger

  Baseline to Week 26

Study Arms (1)

Open-label DCCR

EXPERIMENTAL

75 - 525 mg DCCR

Drug: DCCR (diazoxide choline) extended-release tablets

Interventions

DCCR (diazoxide choline) extended-release tablets DRUG

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

Also known as: DCCR

Open-label DCCR

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide voluntary, written informed consent (parent(s) / legal guardian(s) of patient); provide voluntary, written assent (patients, as appropriate)
• Genetically-confirmed diagnosis of SH2B1 deficiency obesity, obesity associated with PCSK1 mutation (rs6232 variant), or SIM1 deficiency obesity

You may not qualify if:

• Have participated in an interventional clinical study (i.e., investigational drug or device, approved drugs or device evaluated for unapproved use) within 60 days prior to Screening
• Any known disease and/or condition, which would prevent, in the opinion of the Investigator, the patient from completing all study visits and assessments required by the protocol
• Positive urine pregnancy test (in females of child-bearing potential) or females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 30 days after study participation

Sponsors & Collaborators

• Soleno Therapeutics, Inc.: lead

Central Study Contacts

Project Manager

CONTACT

650-353-2051; C615ProjectManager@soleno.life

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: September 8, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share