Trial · NCT03187769

Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder

NCT03187769, Phase 3, Completed, Alkermes, Inc.; results first posted 2023-01-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder. Trials, record NCT03187769. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03187769

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder
NCT number: NCT03187769
Status: Completed
Phases: Phase 3
Enrollment: 426 participants, actual
Lead sponsor: Alkermes, Inc.
Conditions: Schizophrenia, Schizophreniform Disorders, Bipolar I Disorder
Interventions: ALKS 3831, Olanzapine
First posted: 2017-06-15
Last updated: 2023-01-19
Results first posted: 2023-01-19

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Change From Baseline in Body Weight at Week 12	Baseline and 12 weeks	The efficacy analyses were performed using the Final Analysis Set which is defined as all randomized subjects who received one dose of study drug and had at least 1 primary efficacy assessment after administration of study drug
Secondary	Percentage of Subjects With ≥10% Weight Gain at Week 12	Baseline and 12 weeks	Percentage of weight gain is analyzed based on the subject's assessment status (≥10% vs \<10%) at Week 12 using a logistic regression model including treatment group, diagnosis (schizophrenia/schizophreniform disorder vs bipolar I disorder), region (US vs non-US), and baseline BMI (\<25 vs ≥25) as factors and baseline weight as covariate.
Secondary	Percentage of Subjects With ≥7% Weight Gain at Week 12	Baseline and 12 weeks
Secondary	Number of Participants Experiencing of Adverse Events (AEs)	Up to 16 weeks
Secondary	Change From Baseline in Waist Circumference at Week 12	Baseline and Week 12
Secondary	Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score Within the ALKS 3831 Group at Week 12	Baseline and Week 12	Clinical Global Impression-Severity (CGI-S) Score is a 3-item, clinician-rated scale used to assess global illness severity, overall improvement from the start of treatment, and therapeutic response. It is a 7-point scale that requires the clinician to assess how mentally ill the patient is at a specific point in time. Based on the scale, patients are categorized as follows: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients."

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change From Baseline in Body Weight at Week 12	Baseline and 12 weeks	The efficacy analyses were performed using the Final Analysis Set (FAS) which is defined as all randomized subjects who received one dose of study drug and had at least 1 primary efficacy assessment after administration of study drug	Percentage of change in body weight	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Subjects With ≥10% Weight Gain at Week 12	Baseline and 12 weeks	The efficacy analyses were performed using the Final Analysis Set which is defined as all randomized subjects who received one dose of study drug and had at least 1 primary efficacy assessment after administration of study drug	Percentage of participants	NUMBER
SECONDARY	Percentage of Subjects With ≥7% Weight Gain at Week 12	Baseline and 12 weeks	The efficacy analyses were performed using the Final Analysis Set which is defined as all randomized subjects who received one dose of study drug and had at least 1 primary efficacy assessment after administration of study drug	Percentage of participants	NUMBER
SECONDARY	Number of Participants Experiencing of Adverse Events (AEs)	Up to 16 weeks	The safety population included all subjects who received at least 1 dose of study drug.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in Waist Circumference at Week 12	Baseline and Week 12	The efficacy analyses were performed using the Final Analysis Set which is defined as all randomized subjects who received one dose of study drug and had at least 1 primary efficacy assessment after administration of study drug	Centimeters	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score Within the ALKS 3831 Group at Week 12	Baseline and Week 12	The efficacy analyses were performed using the Final Analysis Set which is defined as all randomized subjects who received one dose of study drug and had at least 1 primary efficacy assessment after administration of study drug	units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group11

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percent Change From Baseline in Body Weight at Week 12	ALKS 3831	4.91	Standard Error .597	Percentage of change in body weight
Percent Change From Baseline in Body Weight at Week 12	Olanzapine	6.77	Standard Error .596	Percentage of change in body weight
Percentage of Subjects With ≥10% Weight Gain at Week 12	ALKS 3831	21.9		Percentage of participants
Percentage of Subjects With ≥10% Weight Gain at Week 12	Olanzapine	30.4		Percentage of participants
Percentage of Subjects With ≥7% Weight Gain at Week 12	ALKS 3831	33.1		Percentage of participants
Percentage of Subjects With ≥7% Weight Gain at Week 12	Olanzapine	44.8		Percentage of participants
Number of Participants Experiencing of Adverse Events (AEs)	ALKS 3831	134		Participants
Number of Participants Experiencing of Adverse Events (AEs)	Olanzapine	136		Participants
Change From Baseline in Waist Circumference at Week 12	ALKS 3831	2.99	Standard Error .464	Centimeters
Change From Baseline in Waist Circumference at Week 12	Olanzapine	3.90	Standard Error .477	Centimeters

1 to 10 of 11Source ClinicalTrials.gov

See all 11 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	ALKS 3831	211
Overall Study	STARTED	Olanzapine	215
Overall Study	COMPLETED	ALKS 3831	165
Overall Study	COMPLETED	Olanzapine	161
Overall Study	NOT COMPLETED	ALKS 3831	46
Overall Study	NOT COMPLETED	Olanzapine	54

Source ClinicalTrials.gov

Adverse events50

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Weight Increased	Investigations	ALKS 3831	46	211
other	Weight Increased	Investigations	Olanzapine	55	215
other	Somnolence	Nervous system disorders	ALKS 3831	23	211
other	Somnolence	Nervous system disorders	Olanzapine	20	215
other	Alanine aminotransferase increased	Investigations	ALKS 3831	16	211
other	Alanine aminotransferase increased	Investigations	Olanzapine	14	215
other	Headache	Nervous system disorders	ALKS 3831	13	211
other	Headache	Nervous system disorders	Olanzapine	10	215
other	Sedation	Nervous system disorders	ALKS 3831	11	211
other	Sedation	Nervous system disorders	Olanzapine	13	215

1 to 10 of 50Source ClinicalTrials.gov

See all 50 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ALKS 3831	1	211
Total, all-cause mortality	Olanzapine	0	215
Total, other adverse events	ALKS 3831	134	211
Total, other adverse events	Olanzapine	136	215
Total, serious adverse events	ALKS 3831	8	211
Total, serious adverse events	Olanzapine	8	215

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36946605	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
ALKS 3831 vs Olanzapine: Number of Participants Experiencing of Adverse Events (AEs)	Trial comparisons
ALKS 3831 vs Olanzapine: deaths from any cause	Trial comparisons
ALKS 3831 vs Olanzapine: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03187769

GET https://conductscience.org/api/trials/v1/NCT03187769/events?page=2

API reference For AI assistants