SchizophreniaPhase 3NCT01487083

A Long-Term Safety Study of Pomaglumetad Methionil in Schizophrenia

A Phase 3 study testing Pomaglumetad methionil in people with Schizophrenia, run by Denovo Biopharma LLC at 51 sites in 11 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to evaluate the long-term safety of pomaglumetad methionil in participants with schizophrenia. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia
What is being tested?: Pomaglumetad methionil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 129 participants
Where: 51 sitesin 11 countries
Study dates: Dec 2011to Oct 2012
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants are clinically diagnosed with schizophrenia
Female participants of childbearing potential must test negative for pregnancy at study entry and agree to use a single, effective, medically acceptable method of birth control
New participants must require initiation of or modification to current antipsychotic treatment, as indicated by their present clinical psychiatric status and/or treatment tolerability as outpatients. Criterion does not apply to participants rolling over from a feeder study (NCT01328093 and NCT01452919)
Participants must be considered reliable and have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures
Participants must be able to understand the nature of the study and have given their own informed consent

Who cannot join

Are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an investigational product (IP) or nonapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study, except for participants who are rolling over from a feeder study (NCT01328093 and NCT01452919) who will have completed a clinical trial of pomaglumetad methionil
Have any other current psychiatric diagnoses in addition to schizophrenia
Have previously completed or withdrawn from this study, or any other study investigating pomaglumetad methionil or any predecessor molecules with glutamatergic activity, except for participants who are rolling over from a feeder study (NCT01328093 and NCT01452919) who will have completed a clinical trial of pomaglumetad methionil
Participants who have received an adequate treatment trial, in the opinion of the investigator, with clozapine at doses greater than 200 mg daily within 12 months prior to study entry, or who have received any clozapine at all during the month before study entry
Participants who have a history of an inadequate clinical response to antipsychotic treatment for schizophrenia
Participants who, for any reason, are considered to be a danger to themselves, or who are actively exhibiting suicidal behaviors

Show all 13Show fewer

Female participants who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study
Have known, uncorrected, narrow-angle glaucoma
Participants with current or a history of seizure disorder, leucopenia, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, uncontrolled thyroid condition or other serious or unstable illnesses
Participants who have had electroconvulsive therapy (ECT) within 3 months of study entry or who will have ECT at any time during the study
Participants with known medical history of Human Immunodeficiency Virus (HIV) positive status
Participants who test positive for (1) Hepatitis C virus antibody or (2) Hepatitis B surface antigen (HBsAg) with or without positive Hepatitis B core total antibody
Participants with a corrected QT interval (Bazett's; QTcB) >450 milliseconds (msec) (male) or >470 msec (female) at study entry

Trial locations and contacts

51 sites in 11 countries.

Country

City, postcode or hospital

51 sites in 11 countries

United States36 sites

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Allentown, Pennsylvania, 18104
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Austin, Texas, 78754
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Beachwood, Ohio, 44122
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Brooklyn, New York, 11235
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Cedarhurst, New York, 11516
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Cerritos, California, 90703
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Charlotte, North Carolina, 28211
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Chicago, Illinois, 60640
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Coral Gables, Florida, 33145
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Creve Coeur, Missouri, 63141
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DeSoto, Texas, 75115
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Escondido, California, 92025
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Eugene, Oregon, 97401
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Flowood, Mississippi, 39232
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Fresh Meadows, New York, 11366
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Garden Grove, California, 92845
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Indianapolis, Indiana, 46260
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Lake Charles, Louisiana, 70629
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Lauderhill, Florida, 33319
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Long Beach, California, 90813
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Maitland, Florida, 32751
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Marlton, New Jersey, 08053
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North Miami, Florida, 33161
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Oakland Park, Florida, 33334
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Oklahoma City, Oklahoma, 73103
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Philadelphia, Pennsylvania, 19139
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Princeton, New Jersey, 08540
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Richmond, Virginia, 23230
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Rochester, New York, 14615
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San Diego, California, 92123
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Sanford, Florida, 32771
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Sherman Oaks, California, 91403
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Staten Island, New York, 10312
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Torrance, California, 90502
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Washington D.C., District of Columbia, 20016
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Wharton, Texas, 77488

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Brazil2 sites

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Salvador, 40301500
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São Paulo, 22270-060

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Germany2 sites

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Dresden, 01307
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Oranienburg, 16515

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Poland2 sites

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Bialystok, 15-879
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Gdynia, 81-361

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Spain2 sites

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Madrid, 28031
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Vic, 08500

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Sweden2 sites

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Luleå, SE 972 35
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Malmö, 21153

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Austria1 site

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Vienna, 1010

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France1 site

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Limoges, 87025

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Greece1 site

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Chaïdári, 12462

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Puerto Rico1 site

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San Juan, 00926

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Romania1 site

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Bucharest, 041914

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About this study

Official title: Long-Term Open-Label Safety Study of Pomaglumetad Methionil in Patients With Schizophrenia

The purpose of this study is to evaluate the long-term safety of pomaglumetad methionil in participants with schizophrenia.

Read the detailed description

The primary objective of this study was to evaluate the long-term safety of pomaglumetad methionil (LY2140023) in patients with schizophrenia by monitoring extrapyramidal symptoms (EPS), as evaluated by the Barnes Akathisia Scale (BAS), the Simpson-Angus Scale (SAS), and the Abnormal Involuntary Movement Scale (AIMS); weight; prolactin; and the following metabolic parameters: fasting glucose, total cholesterol, low-density lipoprotein cholesterol (LDL), high-density lipoprotein (HDL) cholesterol, and total triglycerides.

Conditions: Schizophrenia
Being tested: Pomaglumetad methionil
Keywords: schizophrenia, LY2140023, pomaglumetad methionil
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pomaglumetad methionilDrug
Also called LY2140023
Administered orally

Study groups in NCT01487083
Study group	Role	What they receive
Pomaglumetad methionil	Experimental	Pomaglumetad methionil will be administered orally. Participants entering the study will be flexibly dosed between 20 milligrams (mg), 40 mg, or 80 mg twice daily. Receives: Drug: Pomaglumetad methionil

What is being measured

The primary outcome is the main question the study is designed to answer.

Categorical change from baseline up to 5 years in Barnes Akathisia Scale (BAS)
Measured: Baseline, up to 5 years
Categorical change from baseline up to 5 years in Simpson-Angus Scale (SAS)
Measured: Baseline, up to 5 years
Categorical change from baseline up to 5 years in Abnormal Involuntary Movement Scale (AIMS)
Measured: Baseline, up to 5 years
Proportion of participants with clinically significant weight change from baseline up to 5 years
Measured: Baseline up to 5 years
Categorical change from baseline up to 5 years in prolactin level
Measured: Baseline, up to 5 years
Categorical change from baseline up to 5 years in fasting glucose and lipids
Measured: Baseline, up to 5 years

Secondary outcomes (4)

Time to lack of efficacy
Measured: Baseline up to 5 years
Number of participants with suicidal behaviors and ideations measured by Columbia Suicide Severity Rating Scale (CSSRS)
Measured: Baseline up to 5 years
Change from baseline up to 5 years in Clinical Global Impressions-Severity (CGI-S)
Measured: Baseline, up to 5 years
Change from baseline up to 5 years in Brief Psychiatric Rater Scale (BPRS)
Measured: Baseline, up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Oct 2012

First posted7 Dec 2011 (estimated)
Study startDec 2011
Primary completionOct 2012
Study completionOct 2012

Why it stopped: The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SchizophreniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01487083
Sponsor's protocol ID: 12666
Other IDs: H8Y-MC-HBBV
Status last verified: Oct 2022
First submitted: 30 Nov 2011
Last updated: 14 Sep 2026
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-Term Open-Label Safety Study of Pomaglumetad Methionil in Patients With Schizophrenia
ClinicalTrials.gov ID: NCT01487083
Acronym / sponsor ID: 12666
Conditions: Schizophrenia
Keywords: schizophrenia, LY2140023, pomaglumetad methionil
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population.
Enrolment: 129 participants (actual)
Lead sponsor: Denovo Biopharma LLCIndustry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: Oct 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 7 Dec 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the long-term safety of pomaglumetad methionil in participants with schizophrenia.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pomaglumetad methionil	Experimental	Drug: Pomaglumetad methionilPomaglumetad methionil will be administered orally. Participants entering the study will be flexibly dosed between 20 milligrams (mg), 40 mg, or 80 mg twice daily.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Participants are clinically diagnosed with schizophrenia
Female participants of childbearing potential must test negative for pregnancy at study entry and agree to use a single, effective, medically acceptable method of birth control
New participants must require initiation of or modification to current antipsychotic treatment, as indicated by their present clinical psychiatric status and/or treatment tolerability as outpatients. Criterion does not apply to participants rolling over from a feeder study (NCT01328093 and NCT01452919)
Participants must be considered reliable and have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures
Participants must be able to understand the nature of the study and have given their own informed consent

Key exclusion criteria (13 listed)

Are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an investigational product (IP) or nonapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study, except for participants who are rolling over from a feeder study (NCT01328093 and NCT01452919) who will have completed a clinical trial of pomaglumetad methionil
Have any other current psychiatric diagnoses in addition to schizophrenia
Have previously completed or withdrawn from this study, or any other study investigating pomaglumetad methionil or any predecessor molecules with glutamatergic activity, except for participants who are rolling over from a feeder study (NCT01328093 and NCT01452919) who will have completed a clinical trial of pomaglumetad methionil
Participants who have received an adequate treatment trial, in the opinion of the investigator, with clozapine at doses greater than 200 mg daily within 12 months prior to study entry, or who have received any clozapine at all during the month before study entry
Participants who have a history of an inadequate clinical response to antipsychotic treatment for schizophrenia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pomaglumetad methionilAlso: LY2140023Administered orally	Drug	Pomaglumetad methionil

Primary outcome

Categorical change from baseline up to 5 years in Barnes Akathisia Scale (BAS)
Time frame: Baseline, up to 5 years
Categorical change from baseline up to 5 years in Simpson-Angus Scale (SAS)
Time frame: Baseline, up to 5 years
Categorical change from baseline up to 5 years in Abnormal Involuntary Movement Scale (AIMS)
Time frame: Baseline, up to 5 years
Proportion of participants with clinically significant weight change from baseline up to 5 years
Time frame: Baseline up to 5 years
Categorical change from baseline up to 5 years in prolactin level
Time frame: Baseline, up to 5 years
Categorical change from baseline up to 5 years in fasting glucose and lipids
Time frame: Baseline, up to 5 years

4 secondary outcomes

Time to lack of efficacy
Time frame: Baseline up to 5 years
Number of participants with suicidal behaviors and ideations measured by Columbia Suicide Severity Rating Scale (CSSRS)
Time frame: Baseline up to 5 years
Change from baseline up to 5 years in Clinical Global Impressions-Severity (CGI-S)
Time frame: Baseline, up to 5 years
Change from baseline up to 5 years in Brief Psychiatric Rater Scale (BPRS)
Time frame: Baseline, up to 5 years

Results and safety

The study was stopped early (reason given: The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

51 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pomaglumetad methionil in people with Schizophrenia, run by Denovo Biopharma LLC at 51 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Brazil, Germany, Poland, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Categorical change from baseline up to 5 years in Barnes Akathisia Scale (BAS) (time frame: Baseline, up to 5 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01487083.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.