Anorexia NervosaPhase 2NCT01642550
Phase 2 Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia Nervosa
A Phase 2 study testing RM-131 in people with Anorexia Nervosa, run by Motus Therapeutics, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine if administration of RM-131 is effective in improving appetite and gastrointestinal symptoms leading to the recovery of patients with anorexia nervosa in the outpatient setting. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- RM-131
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Mar 2015
- Phase
- Phase 2
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- DSM-IV criteria for anorexia nervosa, including weight <85% of ideal body weight (IBW) and amenorrhea for three months;
- Age 18-45 years old;
- Gastrointestinal tract symptoms;
- Non-hormonal method of birth control, which must be used throughout the study. Female patients unable to bear children must have this documented (i.e., tubal ligation, hysterectomy, or post-menopausal, defined as a minimum of one year since the last menstrual period and elevated FSH);
- Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to baseline;
- Able to provide written informed consent prior to any study procedures and be willing and able to comply with study procedures, including daily SC injections and completion of a daily injection log.
- Patient has a primary care physician or treatment team managing her care.
Who cannot join
- Use of hormone therapy (including but not limited to estrogen, progesterone) or hormonal methods of birth control (i.e., oral, implantable, or injectable) within eight weeks of screening; or Depo-Provera within six months of screening;
- Pregnancy, lactation or breastfeeding, or a positive serum or urine pregnancy test, within eight weeks of screening;
- History of diabetes mellitus;
- History of purging behaviors greater than once monthly within the last three months;
- Active substance abuse;
- Use of metoclopramide, erythromycin, 5HT3 anti-emetics, or opioid medications within 2 weeks prior to baseline. [Note: these drugs should also not be used post-baseline];
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- Hematocrit < 30.0 %, hemoglobin < 10.0 g/dl, potassium < 3.0 mmol/L, fasting glucose > 100 mg/dL, creatinine > 1.5 mg/dL, AST or ALT > 1.5 times the upper limit of normal, or abnormal plasma thyroid stimulating hormone (TSH) level;
- Currently receiving parenteral feeding or enteral feeding, or presence of a nasogastric or other enteral tube for feeding or decompression;
- History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, bariatric procedure, small or large bowel resection;
- Clinical suspicion, in the opinion of the investigator, of active or symptomatic peptic ulcer disease, cholelithiasis, colitis, celiac sprue, or inflammatory bowel disease;
- Active suicidal ideation;
- Beck Depression Inventory-2 score of ≥ 29;
- Current inpatient hospitalization;
- Allergic or intolerant of egg, milk, wheat or algae, as these are components of the GEBT test meal;
- Participation in a clinical study with an investigational medication or device within the 30 days prior to dosing in the present study;
- Any other reason, which in the opinion of the Investigator, including severe renal, hepatic or cardiac disease, would confound proper interpretation of the study or expose a patient to unacceptable risk.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Phase 2, Investigator-Initiated, Randomized, Double-blind, Placebo-controlled Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia Nervosa
The purpose of this study is to determine if administration of RM-131 is effective in improving appetite and gastrointestinal symptoms leading to the recovery of patients with anorexia nervosa in the outpatient setting.
- Conditions
- Anorexia Nervosa
- Being tested
- RM-131, Placebo
- Keywords
- Anorexia nervosa, Anorexia, Eating disorders
- Medical subject headings
- Anorexia Nervosa, Anorexia, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RM-131Drug
RM-131 (100 mcg) will be administered daily by subcutaneous injection for 28 days.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| RM-131 | Active comparator | Active study drug - RM-131 Receives: Drug: RM-131 |
| Placebo | Placebo comparator | Placebo comparator Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of RM-131 on body weight
Change from baseline in body weight.
Measured: Baseline and Day 28
Secondary outcomes (2)
Effect of RM-131 on gastric emptying time
Change from baseline in gastric half-emptying time (t1/2).
Measured: Baseline and Day 28
Effect of RM-131 on appetite
Change from baseline in appetite.
Measured: Baseline and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Motus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne Klibanski, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642550
- Sponsor's protocol ID
- RM-131-005
- Status last verified
- Sep 2016
- First submitted
- 13 Jul 2012
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fazeli PK, Lawson EA, Faje AT, Eddy KT, Lee H, Fiedorek FT, Breggia A, Gaal IM, DeSanti R, Klibanski A. Treatment With a Ghrelin Agonist in Outpatient Women With Anorexia Nervosa: A Randomized Clinical Trial. J Clin Psychiatry. 2018 Jan/Feb;79(1):17m11585. doi: 10.4088/JCP.17m11585.
PubMed 29325236
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Investigator-Initiated, Randomized, Double-blind, Placebo-controlled Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT01642550
- Acronym / sponsor ID
- RM-131-005
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia nervosa, Anorexia, Eating disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Motus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 17 Jul 2012 (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 determine if administration of RM-131 is effective in improving appetite and gastrointestinal symptoms leading to the recovery of patients with anorexia nervosa in the outpatient setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RM-131 | Active comparator | Drug: RM-131Active study drug - RM-131 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo comparator |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- DSM-IV criteria for anorexia nervosa, including weight <85% of ideal body weight (IBW) and amenorrhea for three months;
- Age 18-45 years old;
- Gastrointestinal tract symptoms;
- Non-hormonal method of birth control, which must be used throughout the study. Female patients unable to bear children must have this documented (i.e., tubal ligation, hysterectomy, or post-menopausal, defined as a minimum of one year since the last menstrual period and elevated FSH);
- Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to baseline;
Key exclusion criteria (16 listed)
- Use of hormone therapy (including but not limited to estrogen, progesterone) or hormonal methods of birth control (i.e., oral, implantable, or injectable) within eight weeks of screening; or Depo-Provera within six months of screening;
- Pregnancy, lactation or breastfeeding, or a positive serum or urine pregnancy test, within eight weeks of screening;
- History of diabetes mellitus;
- History of purging behaviors greater than once monthly within the last three months;
- Active substance abuse;
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 |
|---|---|---|
| RM-131RM-131 (100 mcg) will be administered daily by subcutaneous injection for 28 days. | Drug | RM-131 |
| Placebo | Drug | Placebo |
Primary outcome
Effect of RM-131 on body weight
Time frame: Baseline and Day 28
Change from baseline in body weight.
2 secondary outcomes
Effect of RM-131 on gastric emptying time
Time frame: Baseline and Day 28
Effect of RM-131 on appetite
Time frame: Baseline and Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- Derived from this study: PubMed 29325236Fazeli PK, Lawson EA, Faje AT, Eddy KT, Lee H, Fiedorek FT, Breggia A, Gaal IM, DeSanti R, Klibanski A. Treatment With a Ghrelin Agonist in Outpatient Women With Anorexia Nervosa: A Randomized Clinical Trial. J Clin Psychiatry. 2018 Jan/Feb;79(1):17m11585. doi: 10.4088/JCP.17m11585.
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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.
Anne Klibanski, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RM-131 in people with Anorexia Nervosa, run by Motus Therapeutics, Inc. at 1 site 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 7 inclusion and 16 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 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect of RM-131 on body weight (time frame: Baseline and Day 28). 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 NCT01642550, which also lists 1 linked publication.
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 23 Sep 2016.