Hypothalamic ObesityPhase 2NCT07156578
A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)
A Phase 2 study testing Bivamelagon in people with Hypothalamic Obesity, run by Rhythm Pharmaceuticals, Inc. at 9 sites in 2 countries.
Trial summary
This is a long-term, open-label extension study of bivamelagon in participants with Hypothalamic Obesity (HO) who have transitioned from the index study, LG-MCCL005. The study will last up to 2 years. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hypothalamic Obesity
- What is being tested?
- Bivamelagon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 10 Nov 2025to 15 Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Completed LG-MCCL005 and participant demonstrated adequate safety and tolerability in that study as determined by the Investigator.
- Agree to use a highly effective form of contraception and follow contraception requirements throughout the study and for 90 days after.
Who cannot join
- Willing to remain off of: CYP3A4 inhibitors, strong CYP3A4 inducers, and P-glycoprotein inhibitors or substrates for the duration of the study.
- In the opinion of the Investigator, participant is not suitable to participate in the study.
- Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 2 countries
United States6 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Tufts Medical Center
Boston, Massachusetts, 02111
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
University of Iowa Children's Hospital
Iowa City, Iowa, 52242
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Columbia University
New York, New York, 10027
United Kingdom3 sites
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, B15 2TG
University of Cambridge
Cambridge, CB2 1TN
Great Ormond Street Hospital for Children
London, WC1N 3JH
About this study
Official title: A Long-Term, Open-Label Extension Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)
This is a long-term, open-label extension study of bivamelagon in participants with Hypothalamic Obesity (HO) who have transitioned from the index study, LG-MCCL005. The study will last up to 2 years.
- Conditions
- Hypothalamic Obesity
- Being tested
- Bivamelagon
- Medical subject headings
- Sexual Infantilism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BivamelagonDrug
daily dose of oral bivamelagon
| Study group | Role | What they receive |
|---|---|---|
| Bivamelagon (open-label) | Experimental | Not described Receives: Drug: Bivamelagon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of bivamelagon as assessed by the number and frequency of AEs
Measured: Baseline to up to 2 years
Secondary outcomes (7)
Mean change and mean percentage change from Baseline in BMI in participants ≥18 years of age.
Measured: Baseline to up to 2 years
Mean change in BMI z-score in participants >18 years of age.
Measured: Baseline to up to 2 years
Mean change in and mean percentage change in weight
Measured: Baseline to up to 2 years
Mean change in percentage of the 95th percentile of BMI in participants <18 years of age.
Measured: Baseline to up to 2 years
Percentage of patients who achieve ≥5%,≥10%, ≥15%, and ≥20% reduction in BMI from baseline
Measured: Baseline to up to 2 years
Mean change from Baseline in Physical function (and total score) for the Impact of Weight on Quality of Life-Lite (IWQoL) in participants ≥18 years of age
Measured: Baseline to up to 2 years
Change from Baseline in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides
Measured: Baseline to up 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start10 Nov 2025
- Primary completion15 Apr 2028 (estimated)
- Study completion15 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothalamic 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhythm Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Meeker, MD, Study chair, Rhythm Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156578
- Sponsor's protocol ID
- RM-MC72-002
- Status last verified
- Feb 2026
- First submitted
- 25 Aug 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term, Open-Label Extension Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)
- ClinicalTrials.gov ID
- NCT07156578
- Acronym / sponsor ID
- RM-MC72-002
- Conditions
- Hypothalamic Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Rhythm Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 15 Apr 2028 (estimated)
- Study completion
- 15 Apr 2028 (estimated)
- First posted
- 5 Sep 2025 (actual)
- 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.
This is a long-term, open-label extension study of bivamelagon in participants with Hypothalamic Obesity (HO) who have transitioned from the index study, LG-MCCL005. The study will last up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bivamelagon (open-label) | Experimental | Drug: Bivamelagon |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Completed LG-MCCL005 and participant demonstrated adequate safety and tolerability in that study as determined by the Investigator.
- Agree to use a highly effective form of contraception and follow contraception requirements throughout the study and for 90 days after.
Key exclusion criteria (3 listed)
- Willing to remain off of: CYP3A4 inhibitors, strong CYP3A4 inducers, and P-glycoprotein inhibitors or substrates for the duration of the study.
- In the opinion of the Investigator, participant is not suitable to participate in the study.
- Other protocol defined Inclusion/Exclusion criteria may apply.
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 |
|---|---|---|
| Bivamelagondaily dose of oral bivamelagon | Drug | Bivamelagon (open-label) |
Primary outcome
Safety and tolerability of bivamelagon as assessed by the number and frequency of AEs
Time frame: Baseline to up to 2 years
7 secondary outcomes
Mean change and mean percentage change from Baseline in BMI in participants ≥18 years of age.
Time frame: Baseline to up to 2 years
Mean change in BMI z-score in participants >18 years of age.
Time frame: Baseline to up to 2 years
Mean change in and mean percentage change in weight
Time frame: Baseline to up to 2 years
Mean change in percentage of the 95th percentile of BMI in participants <18 years of age.
Time frame: Baseline to up to 2 years
Percentage of patients who achieve ≥5%,≥10%, ≥15%, and ≥20% reduction in BMI from baseline
Time frame: Baseline to up to 2 years
Mean change from Baseline in Physical function (and total score) for the Impact of Weight on Quality of Life-Lite (IWQoL) in participants ≥18 years of age
Time frame: Baseline to up to 2 years
Change from Baseline in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides
Time frame: Baseline to up 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity
Hypothalamic Obesity, Hypothalamic Tumor
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A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment
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Hypothalamic GLP-1 Response in Healthy Weight and Obesity
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SEMAFORCRANIO : Multicenter, Double-blind, Parallel, Randomized Controlled Trial of the Efficacy of Semaglutide in Hypothalamic Obesity Secondary to Craniopharyngioma in Children Aged 12 to 17 Years
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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.
David Meeker, MD study chair
Rhythm Pharmaceuticals, Inc.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bivamelagon in people with Hypothalamic Obesity, run by Rhythm Pharmaceuticals, Inc. at 9 sites in 2 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 2 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, United Kingdom. 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Safety and tolerability of bivamelagon as assessed by the number and frequency of AEs (time frame: Baseline to up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2026.