Trial Outcomes & Findings for A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II) (NCT NCT04524403)
NCT ID: NCT04524403
Last Updated: 2024-06-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
150 participants
Primary outcome timeframe
Baseline Day 1 and Week 26
Results posted on
2024-06-13
Participant Flow
Participant milestones
| Measure |
Miricorlilant 600 mg
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.
Miricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing
|
Miricorlilant 900 mg
Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.
Miricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing
|
Placebo
Patients who meet the entry criteria will be randomized to receive placebo for 26 weeks.
Placebo: Placebo for once-daily oral dosing
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
48
|
52
|
|
Overall Study
COMPLETED
|
33
|
37
|
34
|
|
Overall Study
NOT COMPLETED
|
17
|
11
|
18
|
Reasons for withdrawal
| Measure |
Miricorlilant 600 mg
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.
Miricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing
|
Miricorlilant 900 mg
Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.
Miricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing
|
Placebo
Patients who meet the entry criteria will be randomized to receive placebo for 26 weeks.
Placebo: Placebo for once-daily oral dosing
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
3
|
8
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
3
|
|
Overall Study
Adverse Event
|
3
|
1
|
4
|
|
Overall Study
Non-compliant with study drug
|
1
|
2
|
3
|
|
Overall Study
Moved
|
0
|
1
|
0
|
Baseline Characteristics
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)
Baseline characteristics by cohort
| Measure |
Miricorlilant 600 mg
n=50 Participants
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.
Miricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing
|
Miricorlilant 900 mg
n=48 Participants
Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.
Miricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing
|
Placebo
n=52 Participants
Patients who meet the entry criteria will be randomized to receive placebo for 26 weeks.
Placebo: Placebo for once-daily oral dosing
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 10.80 • n=5 Participants
|
46.4 years
STANDARD_DEVIATION 10.88 • n=7 Participants
|
47.5 years
STANDARD_DEVIATION 10.27 • n=5 Participants
|
46.5 years
STANDARD_DEVIATION 10.61 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
128 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
48 participants
n=7 Participants
|
52 participants
n=5 Participants
|
150 participants
n=4 Participants
|
|
Body weight
|
115.41 kg
STANDARD_DEVIATION 24.24 • n=5 Participants
|
108.02 kg
STANDARD_DEVIATION 19.78 • n=7 Participants
|
118.11 kg
STANDARD_DEVIATION 25.71 • n=5 Participants
|
113.98 kg
STANDARD_DEVIATION 23.69 • n=4 Participants
|
|
Waist-to-hip ratio
|
0.991 Ratio
STANDARD_DEVIATION 0.07 • n=5 Participants
|
0.999 Ratio
STANDARD_DEVIATION 0.06 • n=7 Participants
|
0.992 Ratio
STANDARD_DEVIATION 0.08 • n=5 Participants
|
0.994 Ratio
STANDARD_DEVIATION 0.07 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline Day 1 and Week 26Population: The Efficacy Evaluable Population was patients who received ≥4 weeks of study drug and had body weight measurements at Baseline and on Week 26.
Outcome measures
| Measure |
Miricorlilant 600 mg
n=37 Participants
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.
Miricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing
|
Miricorlilant 900 mg
n=39 Participants
Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.
Miricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing
|
Placebo
n=35 Participants
Patients who meet the entry criteria will be randomized to receive placebo once daily for 26 weeks.
Placebo: Placebo for oral dosing
|
|---|---|---|---|
|
Change From Baseline in Body Weight
|
-1.41 kg
Standard Error 0.644
|
-0.91 kg
Standard Error 0.631
|
-1.66 kg
Standard Error 0.644
|
SECONDARY outcome
Timeframe: Baseline Day 1 and Week 26Population: The Efficacy Evaluable Population was patients who received ≥4 weeks of study drug and had body weight measurements at Baseline and on Week 26.
Outcome measures
| Measure |
Miricorlilant 600 mg
n=76 Participants
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.
Miricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing
|
Miricorlilant 900 mg
n=35 Participants
Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.
Miricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing
|
Placebo
Patients who meet the entry criteria will be randomized to receive placebo once daily for 26 weeks.
Placebo: Placebo for oral dosing
|
|---|---|---|---|
|
Change From Baseline in Body Weight for Both Dose Levels of Miricorilant Combined Versus Placebo
|
-1.16 kg
Standard Error 0.454
|
-1.65 kg
Standard Error 0.642
|
—
|
SECONDARY outcome
Timeframe: Baseline Day 1 to Week 26Population: The Efficacy Evaluable Population was patients who received ≥4 weeks of study drug and had Baseline and ≥1 body weight measurement on or after Week 4.
Percentage of patients achieving a ≥5% weight loss for 600 mg miricorilant versus placebo and 900 mg miricorilant versus placebo
Outcome measures
| Measure |
Miricorlilant 600 mg
n=45 Participants
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.
Miricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing
|
Miricorlilant 900 mg
n=46 Participants
Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.
Miricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing
|
Placebo
n=48 Participants
Patients who meet the entry criteria will be randomized to receive placebo once daily for 26 weeks.
Placebo: Placebo for oral dosing
|
|---|---|---|---|
|
Percentage of Patients Achieving a ≥5% Weight Loss for Miricorilant Versus Placebo
|
12 Participants
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline Day 1 and Week 26Population: The Efficacy Evaluable Population was patients who received ≥4 weeks of study drug and had weight and hip measurements at Baseline and on Week 26.
Outcome measures
| Measure |
Miricorlilant 600 mg
n=37 Participants
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.
Miricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing
|
Miricorlilant 900 mg
n=39 Participants
Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.
Miricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing
|
Placebo
n=35 Participants
Patients who meet the entry criteria will be randomized to receive placebo once daily for 26 weeks.
Placebo: Placebo for oral dosing
|
|---|---|---|---|
|
Change From Baseline in Waist-to-hip Ratio for Miricorilant Versus Placebo
|
0.002 Ratio
Standard Error 0.0077
|
0.009 Ratio
Standard Error 0.0075
|
0.002 Ratio
Standard Error 0.0077
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline Day 1 to Week 30Population: The Safety Population was patients who received ≥1 dose of study drug.
Outcome measures
| Measure |
Miricorlilant 600 mg
n=50 Participants
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.
Miricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing
|
Miricorlilant 900 mg
n=48 Participants
Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.
Miricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing
|
Placebo
n=52 Participants
Patients who meet the entry criteria will be randomized to receive placebo once daily for 26 weeks.
Placebo: Placebo for oral dosing
|
|---|---|---|---|
|
Number of Patients With One or More Treatment-emergent Adverse Events
|
26 Participants
|
21 Participants
|
21 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline Day 1 to Week 30Population: The Safety Population was patients who received ≥1 dose of study drug.
Outcome measures
| Measure |
Miricorlilant 600 mg
n=50 Participants
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.
Miricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing
|
Miricorlilant 900 mg
n=48 Participants
Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.
Miricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing
|
Placebo
n=52 Participants
Patients who meet the entry criteria will be randomized to receive placebo once daily for 26 weeks.
Placebo: Placebo for oral dosing
|
|---|---|---|---|
|
Number of Patients With One or More Treatment-emergent Serious Adverse Events
|
1 Participants
|
2 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline Day 1 to Week 30Population: The Safety Population was patients who received ≥1 dose of study drug.
Outcome measures
| Measure |
Miricorlilant 600 mg
n=50 Participants
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.
Miricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing
|
Miricorlilant 900 mg
n=48 Participants
Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.
Miricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing
|
Placebo
n=52 Participants
Patients who meet the entry criteria will be randomized to receive placebo once daily for 26 weeks.
Placebo: Placebo for oral dosing
|
|---|---|---|---|
|
Number of Patients With One or More Treatment-emergent Adverse Events Leading to Study Drug Discontinuation
|
7 Participants
|
5 Participants
|
4 Participants
|
Adverse Events
Miricorlilant 600 mg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Miricorlilant 900 mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Miricorlilant 600 mg
n=50 participants at risk
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.
Miricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing
|
Miricorlilant 900 mg
n=48 participants at risk
Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.
Miricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing
|
Placebo
n=52 participants at risk
Patients who meet the entry criteria will be randomized to receive placebo for 26 weeks.
Placebo: Placebo for once-daily oral dosing
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/50 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
2.1%
1/48 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
0.00%
0/52 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
|
Psychiatric disorders
Regressive behavior
|
0.00%
0/50 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
0.00%
0/48 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
1.9%
1/52 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
|
Psychiatric disorders
Schizophrenia
|
2.0%
1/50 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
0.00%
0/48 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
0.00%
0/52 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/50 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
0.00%
0/48 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
1.9%
1/52 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/50 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
2.1%
1/48 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
0.00%
0/52 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
Other adverse events
| Measure |
Miricorlilant 600 mg
n=50 participants at risk
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.
Miricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing
|
Miricorlilant 900 mg
n=48 participants at risk
Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.
Miricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing
|
Placebo
n=52 participants at risk
Patients who meet the entry criteria will be randomized to receive placebo for 26 weeks.
Placebo: Placebo for once-daily oral dosing
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
8.0%
4/50 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
4.2%
2/48 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
1.9%
1/52 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
2.0%
1/50 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
2.1%
1/48 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
5.8%
3/52 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
8.0%
4/50 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
2.1%
1/48 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
0.00%
0/52 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
6.0%
3/50 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
2.1%
1/48 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
0.00%
0/52 • Baseline Day 1 to Week 30
The Safety Population was patients who received ≥1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No individual publications will be allowed before publication of the multicenter results, except as agreed with the Sponsor. The Investigator agrees to submit all manuscripts or abstracts to the Sponsor for review before submission to the publisher.
- Publication restrictions are in place
Restriction type: OTHER