Overweight and ObesityPhase 1/2NCT02041195

Phase 1b/2a Study to Evaluate Safety and Efficacy of Setmelanotide in Obese Patients

A Phase 1/2 study testing Setmelanotide in people with Overweight and Obesity, run by Rhythm Pharmaceuticals, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Overweight and Obesity
What is being tested?: Setmelanotide
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 99 participants
Where: 2 sitesUnited States
Study dates: Jan 2014to Dec 2014
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Be between the ages of 18 and 65 years, inclusive.
Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol, prior to any study procedures.
In good general health, without significant medical history, physical examination findings, or clinical laboratory abnormalities.
Body Mass Index: 30 to 40 Kg/m2.
Stable body weight by participant report (+/- 5 Kg) during previous 6 months.
Blood pressure (<140/90 mmHg); may include stable dose (≥ 30 days of use) of up to two anti-hypertensive medications to achieve control and that are intended to remain on a stable dose during the protocol.

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Willingness (during screening) and demonstrated ability (as witnessed in the clinic prior to randomization) to self-administer study medication subcutaneously via a once or twice daily SC injection using a small insulin syringe.
Willing to maintain a healthy diet and exercise regime throughout study as recommended by counseling at study start.
Female participants must have negative serum pregnancy test and must not be lactating. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method (i.e., sponge), or a double-barrier method of birth control (i.e., condom with spermicide) or abstinence must be used/ practiced throughout the study and for 90 days following the study.
Females of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal for at least 12 months (and confirmed with a screening FSH level in the post-menopausal lab range), do not require contraception during the study.
Males with female partners of childbearing potential must agree to a double barrier method if they become sexually active during the study and for 90 days following the study. Male participants must not donate sperm for 90 days following their participation in the study.

Who cannot join

Fasting blood glucose > than 140 mg/dL.
TSH level outside the normal range.
Creatinine > 1.5 times the upper limit of normal.
Liver function tests > 2 times the upper limit of normal.
Active or history of any significant medical condition including renal, hepatic, pulmonary, gastrointestinal, cardiovascular, genitourinary, endocrine, immunologic, metabolic, neurologic or hematological disease.
Patients with a history of the following:

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Uncontrolled hypertension;
Diabetes requiring medical treatment;
Major depressive disorder within the last 2 years;
Any lifetime history of a suicide attempt;
Any suicidal ideation/behavior in the last month;
Other severe psychiatric disorders (e.g. schizophrenia, bipolar disorder, severe eating disorders including bulimia).
A PHQ-9 score of ≥15.
Any suicidal ideation of type 4 or 5 on the C-SSRS.
Prior bariatric surgery.
History or close family history (parents or siblings) of melanoma.
Significant dermatologic findings as part of the Screening comprehensive skin evaluation performed by the dermatologist.
Currently treated with anorectic agents or drugs in last 2 months from screening with anorexia as a frequent side event.
Taking more than 2 anti-hypertensive medications.
Acute illness or history of illness, which in the opinion of the Investigator, could pose a threat or harm to the patient or obscure interpretation of laboratory test results or interpretation of study data.
History of any malignancy, past or present, including skin cancer, multiple severely dysplastic nevi, or nevoid basal cell carcinoma.
History of HIV infection or Hepatitis B or C.
History of significant drug hypersensitivity or anaphylaxis.
History of hypersensitivity to proteins (e.g., allergy shots).
Any clinically significant abnormalities on screening laboratories as determined by the Investigator.
Abnormal 12-lead electrocardiogram (ECG) at screening, except minor deviations deemed to be of no clinical significance by the Investigator. QTcF must be < 450 ms.
Received any experimental drugs or devices or have participated in a clinical study within 30 days prior to dosing.
Blood donation greater than 500 mL within 60 days prior to screening or intent to donate up to 30 days after Final Study Visit.
Hospitalization for surgery within the 3 months prior to screening except for minor outpatient procedures, or any planned hospitalizations during the study period.
Poor venous access or inability to tolerate venipuncture.
Inability to attend all study visits or comply with protocol requirements including fasting and restrictions on concomitant medication intake.
Participation in weight loss programs during the study period, including nutritional supplements/ replacements other than as recommended by nutritional counseling provided at study start.
Use of prescription medications on a regular basis with the following exceptions:
Contraceptives (must be on for ≥3 months);
Hormone replacement therapy (must be on stable dose for ≥3 months);
Antihypertensives (<2 medications on a stable dose for ≥ 30 days);
Statins (dose must be ≤ half the maximum dose; must be on a stable dose ≥3 months);
Thyroxin (stable dose for ≥ 30 days);
The last use of any other prescription medication must have been greater than 5 half-lives for the specific medication or at least 14 days prior to randomization, whichever is longer.
Women who are pregnant or are breast feeding.
Previously randomized and dosed in this study or previously exposed to setmelanotide.
History of alcohol or drug abuse within 5 years of Screening Visit.
Any other reason, which in the opinion of the Investigator, would confound proper evaluation of the study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Study site
Dallas, Texas
Study site
Madison, Wisconsin

Other trials in United States

About this study

Official title: A Staged, Phase 1b/Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety and Efficacy of RM-493, a Melanocortin 4 Receptor (MC4R) Agonist in Obese Patients Using a Once or Twice Daily Sub-Cutaneous Injection Formulation

The purpose of this study is to evaluate the effects of a new daily subcutaneous (SC) injectable formulation of setmelanotide (RM-493) in healthy participants with obesity on mean percent body weight loss and other weight loss parameters, as well as pharmacokinetic (PK) profile. The study is designed to evaluate the efficacy and tolerability of setmelanotide administered once or twice daily. The study drug (setmelanotide and placebo) will be administered in a blinded fashion.

Conditions: Overweight and Obesity
Being tested: Setmelanotide, Placebo
Keywords: Overweight
Medical subject headings: Overweight, Obesity

What participants receive

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

SetmelanotideDrug
Also called RM-493
PlaceboDrug

Study groups in NCT02041195
Study group	Role	What they receive
Setmelanotide Once Daily	Active comparator	Once daily in the morning, equivalent placebo in evening. Receives: Drug: Setmelanotide; Drug: Placebo
Setmelanotide Split Dose	Active comparator	Split dose, one half in the morning and one half in the evening. Receives: Drug: Setmelanotide
Placebo	Placebo comparator	Placebo in the morning, placebo in the evening. Receives: Drug: Placebo

What is being measured

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

Body Weight - Stage A
Measured: Baseline
Percent Change From Baseline in Body Weight at Week 12 - Stage A
Measured: Baseline, Week 12
Body Weight - Stage B
Measured: Baseline
Percent Change From Baseline in Body Weight at Week 12 - Stage B
Measured: Baseline, Week 12
Body Weight - Stage C
Measured: Baseline
Percent Change From Baseline in Body Weight at Week 12 - Stage C
Measured: Baseline, Week 12
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) - Stage A
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs that occurred after the start of study drug administration were considered TEAEs.
Measured: From first dose up to Day 114
Number of Participants With TEAEs - Stage B
An AE was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs that occurred after the start of study drug administration were considered TEAEs.
Measured: From first dose up to Day 114
Number of Participants With TEAEs - Stage C
An AE was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs that occurred after the start of study drug administration were considered TEAEs.
Measured: From first dose up to Day 114

Secondary outcomes (6)

Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage A
Measured: Predose (0 hours) and at 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 22, and 24 hours after dosing on Day 8
Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage C
Measured: Predose (0 hours) and at 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours after dosing on Day 8
Change From Baseline in Ambulatory Blood Pressure Monitoring (ABPM) Parameters During 24-Hour Interval Between Days 8 and 15 - Stage A
The 24-hour ABPM parameters were obtained twice once at Baseline and once during 24-hour interval between Days 8 and 15 for all participants in Stage A. Change from Baseline in ABPM parameters (systolic blood pressure [SBP], diastolic blood pressure [DBP], pulse pressure, mean arterial pressure [MAP]) during 24-hour interval between Days 8 and 15 is presented.
Measured: Baseline and for one 24-hour interval between Days 8 or 15
Change From Baseline in ABPM Parameters During 24-Hour Interval Between Days 8 and 15 - Stage C
The 24-hour ABPM parameters were obtained twice once at Baseline and once during 24-hour interval between Days 8 and 15 for a subset of participants in Stage C. Change from Baseline in ABPM parameters (SBP, DBP, pulse pressure, MAP) during 24-hour interval between Days 8 and 15 is presented.
Measured: Baseline and for one 24-hour interval between Days 8 or 15
Change From Baseline in Heart Rate Using ABPM During 24-Hour Interval Between Days 8 and 15 - Stage A
The 24-hour ABPM parameters were obtained twice once at Baseline and once during 24-hour interval between Days 8 and 15 for all participants in Stage A. Change from Baseline in heart rate during 24-hour interval between Days 8 and 15 is presented.
Measured: Baseline and for one 24-hour interval between Days 8 and 15
Change From Baseline in Heart Rate Using ABPM During 24-Hour Interval Between Days 8 and 15 - Stage C
The 24-hour ABPM parameters were obtained twice once at Baseline and once during 24-hour interval between Days 8 and 15 for a subset of participants in Stage C. Change from Baseline in heart rate during 24-hour interval between Days 8 and 15 is presented.
Measured: Baseline and for one 24-hour interval between Days 8 and 15

Timeline

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

Jan 2014Dec 2014

First posted20 Jan 2014 (estimated)
Study startJan 2014
Primary completionAug 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Overweight and ObesityStudies 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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02041195
Sponsor's protocol ID: RM-493-009
Status last verified: Jul 2023
First submitted: 17 Jan 2014
Last updated: 7 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: 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?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Staged, Phase 1b/Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety and Efficacy of RM-493, a Melanocortin 4 Receptor (MC4R) Agonist in Obese Patients Using a Once or Twice Daily Sub-Cutaneous Injection Formulation
ClinicalTrials.gov ID: NCT02041195
Acronym / sponsor ID: RM-493-009
Conditions: Overweight and Obesity
Keywords: Overweight
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 99 participants (actual)
Lead sponsor: Rhythm Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2014 (actual)
Primary completion: Aug 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 20 Jan 2014 (estimated)
Results: Posted 7 Aug 2023

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Setmelanotide Once Daily	Active comparator	Drug: Setmelanotide, Drug: PlaceboOnce daily in the morning, equivalent placebo in evening.
Setmelanotide Split Dose	Active comparator	Drug: SetmelanotideSplit dose, one half in the morning and one half in the evening.
Placebo	Placebo comparator	Drug: PlaceboPlacebo in the morning, placebo in the evening.

Who may qualify

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

Key inclusion criteria (11 listed)

Be between the ages of 18 and 65 years, inclusive.
Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol, prior to any study procedures.
In good general health, without significant medical history, physical examination findings, or clinical laboratory abnormalities.
Body Mass Index: 30 to 40 Kg/m2.
Stable body weight by participant report (+/- 5 Kg) during previous 6 months.

Key exclusion criteria (43 listed)

Fasting blood glucose > than 140 mg/dL.
TSH level outside the normal range.
Creatinine > 1.5 times the upper limit of normal.
Liver function tests > 2 times the upper limit of normal.
Active or history of any significant medical condition including renal, hepatic, pulmonary, gastrointestinal, cardiovascular, genitourinary, endocrine, immunologic, metabolic, neurologic or hematological disease.

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
SetmelanotideAlso: RM-493	Drug	Setmelanotide Once Daily, Setmelanotide Split Dose
Placebo	Drug	Placebo, Setmelanotide Once Daily

Primary outcome

Body Weight - Stage A
Time frame: Baseline
Percent Change From Baseline in Body Weight at Week 12 - Stage A
Time frame: Baseline, Week 12
Body Weight - Stage B
Time frame: Baseline
Percent Change From Baseline in Body Weight at Week 12 - Stage B
Time frame: Baseline, Week 12
Body Weight - Stage C
Time frame: Baseline
Percent Change From Baseline in Body Weight at Week 12 - Stage C
Time frame: Baseline, Week 12
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) - Stage A
Time frame: From first dose up to Day 114
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs that occurred after the start of study drug administration were considered TEAEs.
Number of Participants With TEAEs - Stage B
Time frame: From first dose up to Day 114
An AE was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs that occurred after the start of study drug administration were considered TEAEs.
Number of Participants With TEAEs - Stage C
Time frame: From first dose up to Day 114
An AE was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs that occurred after the start of study drug administration were considered TEAEs.

6 secondary outcomes

Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage A
Time frame: Predose (0 hours) and at 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 22, and 24 hours after dosing on Day 8
Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage C
Time frame: Predose (0 hours) and at 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours after dosing on Day 8
Change From Baseline in Ambulatory Blood Pressure Monitoring (ABPM) Parameters During 24-Hour Interval Between Days 8 and 15 - Stage A
Time frame: Baseline and for one 24-hour interval between Days 8 or 15
Change From Baseline in ABPM Parameters During 24-Hour Interval Between Days 8 and 15 - Stage C
Time frame: Baseline and for one 24-hour interval between Days 8 or 15
Change From Baseline in Heart Rate Using ABPM During 24-Hour Interval Between Days 8 and 15 - Stage A
Time frame: Baseline and for one 24-hour interval between Days 8 and 15
Change From Baseline in Heart Rate Using ABPM During 24-Hour Interval Between Days 8 and 15 - Stage C
Time frame: Baseline and for one 24-hour interval between Days 8 and 15

Results and safety

Results posted to the registry on 7 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stage A: Setmelanotide 0.75 mg BID	10	8
Stage A: Setmelanotide 1.5 mg QD	9	6
Stage A: Placebo 0.75 mg BID	3	3
Stage A: Placebo 1.5 mg QD	3	3
Stage B: Setmelanotide 1.5 mg QD	11	10
Stage B: Placebo 1.5 mg QD	6	6
Stage C: Setmelanotide 2 mg QD	29	22
Stage C: Placebo 2 mg QD	28	25

Primary outcome: Body Weight - Stage A

Time frame: Baseline. Mean (Standard Error). Unit: Kilograms (kg)

Measure	Stage A: Setmelanotide 0.75 mg BID n = 10	Stage A: Setmelanotide 1.5 mg QD n = 9	Stage A: Placebo n = 6
Value	101.7 (5.09)	101.7 (4.24)	94.5 (3.85)

Population analysed: Full Analysis Set (FAS) included all participants with a baseline and at least one post-dose efficacy observation. Data from 2 placebo groups were combined for the efficacy analysis.

Primary outcome: Percent Change From Baseline in Body Weight at Week 12 - Stage A

Time frame: Baseline, Week 12. Least squares mean (95% Confidence Interval). Unit: percent change

Measure	Stage A: Setmelanotide 0.75 mg BID n = 8	Stage A: Setmelanotide 1.5 mg QD n = 6	Stage A: Placebo n = 6
Value	-1.38 (-3.27 to 0.52)	-0.74 (-2.77 to 1.28)	2.89 (0.53 to 5.25)

Stage A: Setmelanotide 0.75 mg BID vs Stage A: Placebo: Least Squares (LS) Mean Difference: -4.26 (90% CI -6.81 to -1.72), p = 0.004, Longitudinal mixed analysis of variance
Stage A: Setmelanotide 1.5 mg QD vs Stage A: Placebo: LS Mean difference: -3.63 (90% CI -6.23 to -1.03), p = 0.012, Longitudinal mixed analysis of variance

Population analysed: Participants in the FAS with available data were analyzed. Data from 2 placebo groups were combined for the efficacy analysis.

Primary outcome: Body Weight - Stage B

Time frame: Baseline. Mean (Standard Error). Unit: kg

Measure	Stage B: Setmelanotide 1.5 mg QD n = 11	Stage B: Placebo 1.5 mg QD n = 6
Value	99.4 (3.51)	93.3 (2.92)

Population analysed: Participants in the FAS were analyzed.

Primary outcome: Percent Change From Baseline in Body Weight at Week 12 - Stage B

Time frame: Baseline, Week 12. Least squares mean (95% Confidence Interval). Unit: percent change

Measure	Stage B: Setmelanotide 1.5 mg QD n = 10	Stage B: Placebo 1.5 mg QD n = 5
Value	-1.29 (-2.47 to -0.11)	2.28 (0.68 to 3.88)

Stage B: Setmelanotide 1.5 mg QD vs Stage B: Placebo 1.5 mg QD: LS Mean Difference: -3.57 (90% CI -5.24 to -1.89), p <0.001, Longitudinal mixed analysis of variance

Population analysed: Participants in the FAS with available data were analyzed.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose up to Day 114. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stage A: Setmelanotide 0.75 mg BID	0 of 10 (0%)	10 of 10 (100%)	0 of 10
Stage A: Setmelanotide 1.5 mg QD	0 of 9 (0%)	8 of 9 (88.9%)	0 of 9
Stage A: Placebo 0.75 mg BID	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
Stage A: Placebo 1.5 mg QD	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Stage B: Setmelanotide 1.5 mg QD	0 of 11 (0%)	9 of 11 (81.8%)	0 of 11
Stage B: Placebo 1.5 mg QD	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Stage C: Setmelanotide 2 mg QD	1 of 29 (3.4%)	29 of 29 (100%)	0 of 29
Stage C: Placebo 2 mg QD	1 of 28 (3.6%)	21 of 28 (75%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

David Meeker, MD study chair

Rhythm Pharmaceuticals, Inc.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Setmelanotide in people with Overweight and Obesity, run by Rhythm Pharmaceuticals, Inc. at 2 sites in United States.

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 11 inclusion and 43 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: finished, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Body Weight - Stage A (time frame: Baseline). The study lists 9 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 NCT02041195.

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 7 Aug 2023; AzTrials last refreshed its copy on 31 Oct 2026.