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AGO178

Phase 4

Hepatic Impairment | Small molecule | Gastrointestinal |Novartis AG|Trials Updated: May 11, 2021

AGO178 development status

Highest phase Phase 4 run by Central Institute of Mental Health, Mannheim (NCT01822418)
Phase scored for NVSPhase 1
Registered trials 9 across 5 sponsors since Dec 2006

AGO178 target and mechanism

ModalitySmall molecule

Also known as Agomelatine

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials7
Total Enrollment3,359

FDA Designations

No designations recorded

AGO178 clinical trials

AGO178 · 7 trials · 3 indications

Phase 3 6Phase 1 1
NCT01110889Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive DisorderMajor Depressive Disorder
COMPLETED582 Analytics
NCT01110902Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder (MDD)Major Depressive Disorder
COMPLETED589 Analytics
NCT00467402Efficacy, Safety and Tolerability of Agomelatine in the Prevention of Relapse of Major Depressive DisorderMajor Depressive Disorder
COMPLETED644 Analytics
NCT00463242A Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine (25 or 50 mg) in the Treatment of Major Depressive Disorder (MDD)Major Depressive Disorder
COMPLETED501 Analytics
NCT00411099Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive DisorderMajor Depressive Disorder
COMPLETED508 Analytics
NCT00411242Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive DisorderMajor Depressive Disorder (MDD)
COMPLETED503 Analytics
PHASE3COMPLETED
Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder
Major Depressive Disorder
NCT01110889582
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PHASE3COMPLETED
Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder (MDD)
Major Depressive Disorder
NCT01110902589
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PHASE3COMPLETED
Efficacy, Safety and Tolerability of Agomelatine in the Prevention of Relapse of Major Depressive Disorder
Major Depressive Disorder
NCT00467402644
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PHASE3COMPLETED
A Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine (25 or 50 mg) in the Treatment of Major Depressive Disorder (MDD)
Major Depressive Disorder
NCT00463242501
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PHASE3COMPLETED
Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder
Major Depressive Disorder
NCT00411099508
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PHASE3COMPLETED
Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder
Major Depressive Disorder (MDD)
NCT00411242503
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Study Endpoints

Primary Endpoints

Change from Baseline to endpoint at Week 8 using the total score of the Hamilton Depression Rating Scale
Baseline and 8 weeks
Time to relapse, where relapse is defined by the occurrence of any one of the following:
Primary efficacy variable is measured from randomization to relapse
Hamilton Depression Rating Scale total score ≥16 at two consecutive visits;
Primary efficacy variable is measured from randomization to relapse
hospitalization due to depression;
Primary efficacy variable is measured from randomization to relapse
suicide attempt or suicide;
Primary efficacy variable is measured from randomization to relapse
discontinuation due to lack of efficacy according to Investigator judgment.
Primary efficacy variable is measured from randomization to relapse
Change from Baseline to Week 8 on the total score Hamilton Depression Rating Scale
8 weeks
To evaluate the change from Baseline to Week 8 on the total score of the clinician rated 17-Item Hamilton Depression Rating Scale (HAM-D17)
8 weeks
Change from Baseline to Week 8 on the total score of the clinician rated 17-Item Hamilton Depression Rating Scale (HAM-D17)
8 weeks
Maximum Observed Plasma Concentration (Cmax) of AGO178
Predose, 2 minute (min) , 5 min , 10 min, 20 min, 30 min, 45 min, 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 12h, 24h, 36h Post dose

Blood samples will be collected at various time points on day 1 and day 2

Area Under the Plasma Curve (AUC) of AGO178
Predose, 2 min , 5 min , 10 min, 20 min, 30 min, 45 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 12h, 24h, 36h Post dose

Blood samples will be collected at various time points on day 1 and day 2

Secondary Endpoints

Effect on subjective sleep, as measured by the score of the Leeds Sleep Evaluation Questionnaire (LSEQ) domain "quality of sleep" at Week 8
8 weeks
Proportion of patients who demonstrate clinical response, where response is defined by a reduction of at least 50% in the Baseline clinician-rated HAM-D total score at Week 8 endpoint
8 weeks
Proportion of patients who demonstrate clinical improvement at Week 8, where improvement is defined by a score of 1 or 2 on the CGI-I scale
8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AGO178C 0.5 mg /dayEXPERIMENTAL -
AGO178C 1 mg / dayEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
1EXPERIMENTAL -
2EXPERIMENTAL -
3PLACEBO_COMPARATOR -
AgomelatineEXPERIMENTALDosing for each subject in this extension study began with the same dose (25 mg or 50 mg of agomelatine orally once daily) the subject was receiving at the end of Week 8, the week before this study began.
Mild Hepatic Impaired ParticipantsEXPERIMENTALMild hepatic impaired participants will receive a single sublingual dose of AGO178, 1 milligram (mg) on Day 1.
Moderate Hepatic Impaired ParticipantsEXPERIMENTALModerate hepatic impaired participants will receive a single sublingual dose of AGO178, 1 mg on Day 1.
Healthy Participants Matched by Aged, Gender and Body Mass Index (BMI)EXPERIMENTALHealthy participants matched by aged, gender and BMI will receive a single sublingual dose of AGO178, 1 mg on Day 1.

Interventions

NameTypeDescription
Agomelatine (AGO178C)DRUG -
PlaceboDRUG -
agomelatineDRUG -
paroxetineDRUG -
AGO178DRUGAGO178 is administered as a sublingual tablet.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites48

Inclusion Criteria: * Patients with diagnosis of MDD, single or recurrent episode, according to DSM-IV criteria. * Current episode ≥4 weeks. * CGI-Severity score ≥4 at Screening and Baseline. Exclusion Criteria: * History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eat...

Countries:United StatesPuerto Rico
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Frequently asked questions about AGO178

What is AGO178 used for?

AGO178 is an investigational small molecule being studied for use in hepatic impairment, which is reduced liver function. It is in Phase 1 clinical development, and the completed trial evaluated its pharmacokinetics in participants with liver impairment. The drug is not approved and remains under investigation.

Who makes AGO178?

AGO178 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company conducted a Phase 1 clinical trial to study the drug's pharmacokinetics in participants with liver impairment.

What phase is AGO178 in?

AGO178 is in Phase 1 clinical development. The single clinical trial for this drug, which studied its pharmacokinetics in participants with liver impairment, has been completed. AGO178 is an investigational drug and has not been approved by regulatory authorities.

What clinical trials is AGO178 in?

AGO178 has one completed clinical trial, identified as NCT01531309, titled "Pharmacokinetics of AGO178 in Participants With Liver Impairment." This Phase 1 study enrolled 32 participants in the United States, including healthy volunteers, and evaluated the drug's pharmacokinetics in individuals with hepatic impairment.

Is AGO178 FDA approved?

AGO178 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The only clinical trial for AGO178, which studied its pharmacokinetics in participants with liver impairment, has been completed, but the drug has not received marketing approval.

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