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RO6799477

Phase 1

Type 2 Diabetes | Small molecule | Metabolic |Roche Holding AG|Trials Updated: Jun 14, 2017

RO6799477 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Jul 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

RO6799477 clinical trials

RO6799477 · 1 trial · 1 indication

Phase 1 1
NCT02164266A Study to Investigate in Healthy Volunteers (Part 1) and in Patients With Type 2 Diabetes Mellitus (Part 2) the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of RO6799477Healthy Volunteer, Type 2 Diabetes
COMPLETED40 Analytics
PHASE1COMPLETED
A Study to Investigate in Healthy Volunteers (Part 1) and in Patients With Type 2 Diabetes Mellitus (Part 2) the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of RO6799477
Healthy Volunteer, Type 2 DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events (AEs)
Up to 9 weeks

Secondary Endpoints

Pharmacokinetic parameters derived from plasma and urine concentrations of RO6799477, area under the concentration time curve (AUC), Cmax
Day 1 and Day 14
Fasting serum glucose
Up to 9 weeks
Fasting serum insulin (Part 2 only)
Up to 9 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: Healthy VolunteersEXPERIMENTAL -
Part 2: Patients with T2D, Group AEXPERIMENTALLow dose daily oral administration of RO6799477
Part 2: Patients with T2D, Group BEXPERIMENTALHigh dose daily oral administration of RO6799477

Interventions

NameTypeDescription
PlaceboDRUGMatching placebo daily oral administration
RO6799477DRUGDaily oral administration of RO6799477
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Part 1 Inclusion criteria: * Right-handed male volunteers * Aged 18-45 years, inclusive * Healthy participants, as determined by screening assessments and Principal Investigator's judgment * Healthy status is defined by the absence of evidence of any active or chronic disease f...

Countries:Netherlands
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Frequently asked questions about RO6799477

What is RO6799477?

RO6799477 is an investigational small molecule developed by Roche Holding AG for Type 2 Diabetes. It is a Phase 1 clinical candidate in the metabolic therapeutic area. It has been studied in a single completed Phase 1 trial that enrolled 40 participants, including healthy volunteers and patients with Type 2 Diabetes Mellitus.

What is RO6799477 used for in Type 2 Diabetes?

RO6799477 is being developed as a treatment for Type 2 Diabetes. It has been evaluated in a Phase 1 study that included patients with Type 2 Diabetes Mellitus alongside healthy volunteers. The program remains investigational and has not been approved for any indication.

Who is developing RO6799477?

RO6799477 is developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor of the clinical program evaluating the compound in Type 2 Diabetes and in healthy volunteers.

What phase is RO6799477 in?

RO6799477 is in Phase 1 clinical development. Its only recorded trial, NCT02164266, was a Phase 1 study that has been completed. The compound is investigational and has not been approved by the FDA or any other regulatory agency for Type 2 Diabetes or any other indication.

What clinical trials is RO6799477 in?

RO6799477 has been studied in one clinical trial, NCT02164266, titled a study of the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of RO6799477. The Phase 1 trial was completed, enrolled 40 participants, was randomized, double blind, and controlled, and was conducted in the Netherlands.