This section highlights FDA-related milestones and regulatory updates for drugs developed by Rhythm Pharmaceuticals (RYTM).
Over the past two years, Rhythm Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
bivamelagon, IMCIVREE, LB54640, and Setmelanotide. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
bivamelagon - FDA Regulatory Timeline and Events
bivamelagon is a drug developed by Rhythm Pharmaceuticals for the following indication: In patients with acquired hypothalamic obesity.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- bivamelagon
- Announced Date:
- July 9, 2025
- Indication:
- In patients with acquired hypothalamic obesity.
Announcement
Rhythm Pharmaceuticals, Inc. announced positive topline results from its Phase 2 trial evaluating bivamelagon (formerly LB54640), an investigational oral melanocortin-4 receptor (MC4R) agonist, in patients with acquired hypothalamic obesity.
AI Summary
Rhythm Pharmaceuticals, Inc. recently announced positive topline results from its Phase 2 trial evaluating bivamelagon (formerly LB54640), an investigational oral melanocortin-4 receptor (MC4R) agonist. The study focused on patients with acquired hypothalamic obesity, a condition linked to damage in the brain’s hunger control center. It was a randomized, placebo-controlled, double-blind trial that enrolled 28 patients aged 12 and older. Participants received either a low (200 mg), middle (400 mg), or high dose (600 mg) of bivamelagon, or a placebo, on a daily basis over a 14-week period. The primary goal was to measure the change in body mass index from the start of the trial. The promising topline data highlights the potential of bivamelagon to improve weight management, decrease hunger, and enhance quality of life for those affected by hypothalamic obesity.
Read Announcement- Drug:
- bivamelagon
- Announced Date:
- July 8, 2025
- Indication:
- In patients with acquired hypothalamic obesity.
Announcement
Rhythm Pharmaceuticals, Inc announced the Company will hold a conference call and webcast on Wednesday, July 9, 2025 at 8:00 a.m. ET to disclose topline results from the randomized, placebo-controlled portion of the Phase 2 trial evaluating bivamelagon, an investigational oral melanocortin-4 receptor (MC4R) agonist, in patients with acquired hypothalamic obesity.
AI Summary
Rhythm Pharmaceuticals announced that it will hold a conference call and webcast on Wednesday, July 9, 2025 at 8:00 a.m. ET. During the call, the company will share topline results from the randomized, placebo-controlled portion of its Phase 2 trial. This trial is testing bivamelagon, an investigational oral melanocortin-4 receptor (MC4R) agonist, in patients with acquired hypothalamic obesity. The study involves patients who are 12 years and older. Participants in the trial received daily doses of bivamelagon at low (200 mg), middle (400 mg), or high (600 mg) levels, or a placebo, over a 14-week period. The main goal of the research is to assess changes in body mass index from the start of the trial. The live conference call and webcast, which will later be available as an archived version, will provide more details on these clinical findings.
Read Announcement
IMCIVREE (setmelanotide) - FDA Regulatory Timeline and Events
IMCIVREE (setmelanotide) is a drug developed by Rhythm Pharmaceuticals for the following indication: Obesity and Control of Hunger Associated with POMC, PCSK1 and LEPR Deficiency.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IMCIVREE (setmelanotide)
- Announced Date:
- December 20, 2024
- Indication:
- Obesity and Control of Hunger Associated with POMC, PCSK1 and LEPR Deficiency
Announcement
Rhythm Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for IMCIVREE® (setmelanotide) to include children as young as 2 years old.
AI Summary
Rhythm Pharmaceuticals announced that the FDA has expanded the use of its drug IMCIVREE® (setmelanotide) to include children as young as 2 years old. This new indication covers pediatric patients with syndromic or monogenic obesity caused by Bardet-Biedl syndrome (BBS) or genetic deficiencies in pro-opiomelanocortin (POMC), PCSK1, or the leptin receptor (LEPR). These conditions affect the melanocortin-4 receptor (MC4R) pathway, leading to insatiable hunger and early-onset obesity.
This targeted treatment is the first precision medicine aimed at addressing the root cause of abnormal eating behaviors in patients with these rare diseases. By reducing excess body weight and maintaining weight reduction over time, IMCIVREE offers a much-needed option for young children struggling with severe obesity and related health issues. Early intervention with this approved therapy has the potential to lessen long-term complications associated with these conditions.
Read Announcement- Drug:
- IMCIVREE (setmelanotide)
- Announced Date:
- December 3, 2024
- Indication:
- Obesity and Control of Hunger Associated with POMC, PCSK1 and LEPR Deficiency
Announcement
Rhythm Pharmaceuticals, Inc. announced that the United Kingdom's Medicines & Healthcare products Regulatory Agency (MHRA) has expanded the marketing authorization for IMCIVREE® (setmelanotide) to include the treatment of obesity and control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS) or genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or biallelic leptin receptor (LEPR) deficiency in adult and pediatric patients as young as 2 years old and older.
AI Summary
Rhythm Pharmaceuticals announced that the UK’s MHRA has expanded the marketing authorization for IMCIVREE (setmelanotide). Under the new authorization, the treatment is approved for managing obesity and controlling hunger in patients with genetically confirmed Bardet-Biedl syndrome (BBS) or loss-of-function mutations in pro-opiomelanocortin (POMC), including deficiencies in PCSK1 or the leptin receptor (LEPR).
This approval now includes adult and pediatric patients as young as 2 years old. The decision is an important milestone as it offers early therapeutic intervention for young patients suffering from severe obesity and hyperphagia caused by MC4R pathway disorders. Early treatment is crucial to prevent further health complications associated with obesity. The expanded use of IMCIVREE aligns with broader efforts to address and manage rare genetic conditions affecting energy balance and appetite control, with availability expected through the Medicines for Children program by year’s end.
Read Announcement- Drug:
- IMCIVREE (setmelanotide)
- Announced Date:
- August 26, 2024
- Estimated Event Date Range:
- December 26, 2024 - December 26, 2024
- Target Action Date:
- December 26, 2024
- Indication:
- Obesity and Control of Hunger Associated with POMC, PCSK1 and LEPR Deficiency
Announcement
Rhythm Pharmaceuticals, Inc announced that The FDA has granted Priority Review of the sNDA and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2024. .
AI Summary
Rhythm Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for its supplemental New Drug Application (sNDA) for IMCIVREE (setmelanotide). This review is focused on the treatment of obesity due to Bardet-Biedl syndrome or POMC/LEPR deficiency in young children as young as 2 years old. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2024, marking an important step toward providing a precision therapy for children suffering from hyperphagia and severe obesity caused by these rare genetic conditions. The decision highlights the potential for earlier treatment, which may improve the quality of life for affected children and their families by addressing abnormal hunger and weight issues at a younger age.
Read Announcement- Drug:
- IMCIVREE (setmelanotide)
- Announced Date:
- August 26, 2024
- Indication:
- Obesity and Control of Hunger Associated with POMC, PCSK1 and LEPR Deficiency
Announcement
Rhythm Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide), a melanocortin-4 receptor (MC4R) agonist, for the treatment of obesity due to Bardet-Biedl syndrome (BBS) or pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency obesity in children as young as 2 years old.
AI Summary
Rhythm Pharmaceuticals announced that the FDA has accepted its supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide) to treat obesity linked to Bardet-Biedl syndrome (BBS) or genetic obesity due to POMC, including PCSK1, and LEPR deficiency. The treatment is now proposed for children as young as 2 years old. This sNDA is supported by data from a Phase 3 trial involving 12 patients under 6 years old, which showed encouraging improvements in reducing BMI and managing hyperphagia—a condition marked by uncontrollable hunger and abnormal food-seeking behavior.
The FDA has granted Priority Review for the application and set a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2024. If approved, this could provide a new, targeted therapy for very young patients, potentially improving their quality of life and offering relief to families managing these rare, genetically driven conditions.
Read Announcement
LB54640 - FDA Regulatory Timeline and Events
LB54640 is a drug developed by Rhythm Pharmaceuticals for the following indication: In hypothalamic obesity.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LB54640
- Announced Date:
- July 23, 2024
- Indication:
- In hypothalamic obesity.
Announcement
Rhythm Pharmaceuticals, Inc. announced that the first patients have been dosed in the Company's Phase 2 clinical trial evaluating LB54640, an investigational oral melanocortin-4 receptor (MC4R) agonist, in hypothalamic obesity.
AI Summary
Rhythm Pharmaceuticals, Inc. announced that the first patients have been dosed in their Phase 2 clinical trial evaluating LB54640, an investigational oral melanocortin-4 receptor (MC4R) agonist, targeting hypothalamic obesity. The trial is designed as a randomized, placebo-controlled, double-blind study with patients 12 years and older receiving one of three different daily oral doses or a placebo for 14 weeks. The primary goal is to measure changes in body mass index, along with effects on hunger, safety, and quality of life.
Based on encouraging preclinical data and positive Phase 1 results, LB54640 could offer a new oral treatment option for patients struggling with hyperphagia and severe obesity. Rhythm Pharmaceuticals hopes that this study will further demonstrate the potential of LB54640 to treat MC4R pathway diseases effectively, without the side effects, such as hyperpigmentation, seen with some other therapies.
Read Announcement
Setmelanotide (HO) - FDA Regulatory Timeline and Events
Setmelanotide (HO) is a drug developed by Rhythm Pharmaceuticals for the following indication: Hypothalamic Obesity.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Setmelanotide (HO)
- Announced Date:
- June 25, 2025
- Indication:
- Hypothalamic Obesity
Announcement
Rhythm Pharmaceuticals, announced that three late-breaking abstracts have been accepted for presentation at The Endocrine Society's Annual Meeting (ENDO 2025) taking place July 12-15 in San Francisco, CA.
AI Summary
Rhythm Pharmaceuticals announced that three late-breaking abstracts have been accepted for presentation at The Endocrine Society’s Annual Meeting (ENDO 2025) in San Francisco, CA, from July 12-15. This significant event will feature cutting-edge research on treatments for acquired hypothalamic obesity. One highlight is a live oral presentation by Dr. Susan Phillips from the University of California San Diego/Rady Children’s Hospital, who will share data from the pivotal Phase 3 TRANSCEND trial evaluating setmelanotide. In addition, Dr. Christian Roth from Seattle Children’s Research Institute and Dr. Vidhu Thaker from Columbia University will present posters that detail patient exit interviews and results from a Phase 2 trial of an oral MC4R agonist, bivamelagon, respectively.
The presentations aim to strengthen understanding of novel therapeutic strategies for managing obesity linked to neuroendocrine disorders.
Read Announcement- Drug:
- Setmelanotide (HO)
- Announced Date:
- May 14, 2025
- Indication:
- Hypothalamic Obesity
Announcement
Rhythm Pharmaceuticals, announced the presentation of new, real-world data at two European congresses that show consistent improvements in body mass index (BMI), BMI-z, and hunger scores in a total of 35 patients with acquired or congenital hypothalamic obesity who were treated with setmelanotide for up to nine months.
AI Summary
Rhythm Pharmaceuticals recently presented new real-world data from two European congresses showing that setmelanotide therapy led to consistent improvements in patients with hypothalamic obesity. The study involved 35 patients—30 with acquired and five with congenital hypothalamic obesity—who received treatment for up to nine months. Results revealed meaningful reductions in body mass index (BMI) for adults and decreases in BMI-z scores for pediatric patients, with improvements noted as early as three months and deepening at six and nine months. Along with the weight loss benefits, patients also experienced notable reductions in hunger scores. These findings support earlier clinical trial data and underscore the potential of setmelanotide, an MC4R agonist, to address the significant challenges of weight gain and overwhelming hunger in both acquired and congenital hypothalamic obesity.
Read Announcement- Drug:
- Setmelanotide (HO)
- Announced Date:
- April 7, 2025
- Indication:
- Hypothalamic Obesity
Announcement
Rhythm Pharmaceuticals, Inc. announced positive topline results from the pivotal Phase 3 TRANSCEND trial evaluating setmelanotide, a melanocortin-4 receptor (MC4R) agonist, for the treatment of acquired hypothalamic obesity.
AI Summary
Rhythm Pharmaceuticals, Inc. announced positive topline results from its pivotal Phase 3 TRANSCEND trial evaluating setmelanotide, a melanocortin-4 receptor (MC4R) agonist, for treating acquired hypothalamic obesity. The trial showed that patients on setmelanotide experienced a mean BMI reduction of 16.5% at 52 weeks, compared to a 3.3% increase in the placebo group (p<0.0001). Adult patients achieved a 19.2% placebo-adjusted BMI reduction, while those under 18 reached a 20.2% reduction.
The results indicate statistically significant and clinically meaningful improvements for both adult and pediatric patients suffering from this challenging condition. With no new safety concerns observed, the promising data provide hope for a targeted treatment option for acquired hypothalamic obesity. Rhythm Pharmaceuticals plans to submit regulatory applications in the U.S. and EU by the third quarter of 2025.
Read Announcement- Drug:
- Setmelanotide (HO)
- Announced Date:
- April 6, 2025
- Indication:
- Hypothalamic Obesity
Announcement
Rhythm Pharmaceuticals, Inc. announced the Company will hold a conference call and webcast on Monday, April 7, 2025 at 8:00 a.m. ET to disclose topline results from the Pivotal Phase 3 TRANSCEND trial evaluating setmelanotide, a melanocortin-4 receptor (MC4R) agonist, in patients with acquired hypothalamic obesity.
AI Summary
Rhythm Pharmaceuticals, Inc. announced a conference call and webcast on Monday, April 7, 2025 at 8:00 a.m. ET. During this call, the company will reveal topline results from its Pivotal Phase 3 TRANSCEND trial. This trial examines the safety and efficacy of setmelanotide, a melanocortin-4 receptor (MC4R) agonist, in patients suffering from acquired hypothalamic obesity—a condition that arises after damage to the hypothalamus, often following brain surgery or injury.
The TRANSCEND trial is a global, randomized, double-blind, placebo-controlled study involving patients aged 4 years and older. Its primary focus is to assess the mean percent change in body mass index (BMI) from baseline after 52 weeks of treatment, while secondary measures include changes in hunger levels, weight, and overall quality of life. Interested parties can join the conference call or view the webcast through Rhythm Pharmaceuticals’ Investor Relations website.
Read Announcement- Drug:
- Setmelanotide (HO)
- Announced Date:
- March 19, 2025
- Indication:
- Hypothalamic Obesity
Announcement
Rhythm Pharmaceuticals, Inc. announced it has received orphan drug designation from Japan's Ministry of Health, Labour and Welfare (MHLW) for setmelanotide as a treatment for acquired hypothalamic obesity.
AI Summary
Rhythm Pharmaceuticals, Inc. has received orphan drug designation from Japan’s Ministry of Health, Labour and Welfare for setmelanotide as a treatment for acquired hypothalamic obesity. This rare condition, often caused by injuries to the hypothalamus from brain tumors or trauma, leads to rapid and sustained weight gain along with extreme hunger. The designation highlights Japan’s recognition of the high unmet medical need for safe and effective treatments for this debilitating disease.
Setmelanotide, a melanocortin-4 receptor (MC4R) agonist, is being evaluated in a global Phase 3 trial, with top-line results anticipated in the second quarter of 2025. With orphan drug status granted in both Japan and Europe, Rhythm is well positioned to advance its global strategy and potentially provide the first treatment that targets the underlying biology of acquired hypothalamic obesity.
Read Announcement - Drug:
- Setmelanotide (HO)
- Announced Date:
- November 18, 2024
- Indication:
- Hypothalamic Obesity
Announcement
Rhythm Pharmaceuticals, Inc. announced the presentation of new, real-world data that showed four pediatric patients with acquired hypothalamic obesity or congenital hypothalamic obesity achieved >5% weight reduction at three months on setmelanotide, a melanocortin-4 receptor (MC4R) agonist.
AI Summary
Rhythm Pharmaceuticals shared new real-world data showing that four pediatric patients with hypothalamic obesity achieved significant weight loss on setmelanotide therapy. In this French early-access program, two children with congenital hypothalamic obesity and two with acquired hypothalamic obesity experienced more than a 5% reduction in body weight within three months of starting treatment. Setmelanotide, an MC4R agonist, targets the disrupted pathway that contributes to obesity in these patients. The findings support the potential of setmelanotide to address the underlying cause of obesity when traditional lifestyle changes and standard treatments may not work effectively. Building on these encouraging results, Rhythm also announced plans to launch a 34-week substudy to evaluate the treatment in 39 patients with congenital hypothalamic obesity, further exploring its benefits for younger patients facing this challenging condition.
Read Announcement- Drug:
- Setmelanotide (HO)
- Announced Date:
- May 22, 2024
- Indication:
- Hypothalamic Obesity
Announcement
Rhythm Pharmaceuticals, Inc. announced the National Institute for Health and Care Excellence (NICE) has issued guidance that recommends IMCIVREE® (setmelanotide) as an option for treating obesity and the control of hunger (hyperphagia) in genetically confirmed Bardet-Biedl syndrome (BBS) in people 6 years of age and over, if they are between 6 and 17 years of age when treatment starts. Patients may remain on reimbursed setmelanotide as adults whilst they continue to benefit from therapy.
AI Summary
Rhythm Pharmaceuticals announced that the National Institute for Health and Care Excellence (NICE) has recommended IMCIVREE® (setmelanotide) for treating obesity and controlling hunger (hyperphagia) in patients with genetically confirmed Bardet-Biedl syndrome (BBS). The guidance specifies that the treatment is for individuals 6 years and older, provided that therapy begins between the ages of 6 and 17. Importantly, patients who see benefits from the treatment as children may continue to receive reimbursed setmelanotide into adulthood. This endorsement by NICE marks a key step in making targeted treatment available to those with BBS in England and Wales. It also reflects the collaborative efforts between leading clinical experts, advocacy groups, and NICE to address the serious challenges of hyperphagia and severe obesity associated with BBS, offering hope for improved quality of life for affected families.
Read Announcement- Drug:
- Setmelanotide (HO)
- Announced Date:
- May 6, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- 2024-LATE
- Indication:
- Hypothalamic Obesity
Announcement
Rhythm Pharmaceuticals, Inc. announced that Two additional posters presented at PES 2024
AI Summary
Rhythm Pharmaceuticals, Inc. announced two additional posters that will be presented at PES 2024. This move shows the company's commitment to sharing new research and scientific advancements with the medical community. The posters are designed to provide fresh insights into their current studies and help further the discussion of innovative therapies. By adding these presentations, Rhythm Pharmaceuticals hopes to reach a broader audience at the conference, allowing healthcare professionals and researchers to learn more about the potential benefits of their work. The inclusion of these posters supports the company’s goal of staying at the forefront of scientific research and ensuring that the latest findings are shared with key stakeholders. This effort underlines their dedication to improving patient care through continuous investigation and transparent sharing of data at important industry events like PES 2024.
Read Announcement- Drug:
- Setmelanotide (HO)
- Announced Date:
- May 6, 2024
- Indication:
- Hypothalamic Obesity
Announcement
Rhythm Pharmaceuticals, Inc. announced that the Company delivered three presentations – one oral and two posters – at The Pediatric Endocrine Society's (PES) Annual Meeting held May 2-5, 2024 in Chicago, IL.
AI Summary
Rhythm Pharmaceuticals, Inc. made a key appearance at The Pediatric Endocrine Society’s Annual Meeting held in Chicago, IL, from May 2–5, 2024. The company presented three significant contributions at the event – one oral presentation and two poster presentations. These sessions provided an opportunity for Rhythm Pharmaceuticals to share its latest research findings and insights with leading pediatric endocrinologists and healthcare professionals.
The presentations aimed to spark informed discussions about advancements in pediatric endocrinology and potential new therapies. By highlighting innovative research and clinical developments, Rhythm Pharmaceuticals reinforced its commitment to improving care for pediatric patients. The company's active participation in the meeting underscores its ongoing effort to support collaboration and knowledge sharing within the medical community.
Read Announcement- Drug:
- Setmelanotide (HO)
- Announced Date:
- May 6, 2024
- Estimated Event Date Range:
- January 1, 2024 - June 30, 2024
- Target Action Date:
- 2024-H1
- Indication:
- Hypothalamic Obesity
Announcement
Rhythm Pharmaceuticals, Inc. announced that Company remains on track to complete submission of sNDA to the FDA seeking a label expansion for pediatric patients in 1H 2024 --
AI Summary
Rhythm Pharmaceuticals, Inc. has announced that it remains on track to complete the submission of a supplemental New Drug Application (sNDA) to the FDA in the first half of 2024. This submission specifically aims for a label expansion to include pediatric patients, potentially providing a new treatment option for younger populations. The company’s move reflects its commitment to advancing its therapies and meeting the needs of vulnerable patient groups through expanded use of its medications.
The planned sNDA submission is a significant development, as it could lead to the inclusion of pediatric patients in the approved use of the drug, thereby broadening its reach and impact. Industry observers will be watching closely to see if the FDA approves this initiative, which could mark an important milestone for the company and the treatment community.
Read Announcement- Drug:
- Setmelanotide (HO)
- Announced Date:
- April 29, 2024
- Indication:
- Hypothalamic Obesity
Announcement
Rhythm Pharmaceuticals, Inc. announced the publication of previously disclosed results from its Phase 2 study of setmelanotide for the treatment of hypothalamic obesity.
AI Summary
Rhythm Pharmaceuticals recently published results from its Phase 2 study in The Lancet Diabetes & Endocrinology. The study tested setmelanotide for treating hypothalamic obesity, a rare condition that causes rapid, severe weight gain and increased hunger after brain injuries such as tumor removal. In the study, 18 patients were treated with setmelanotide over 16 weeks. Results showed that 89% of patients achieved at least a 5% reduction in their BMI, and 78% reached a 10% or greater reduction. On average, patients experienced a 15% reduction in BMI at 16 weeks, and preliminary long-term data indicated about a 26% reduction after one year of treatment.
Researchers also noted a consistent decrease in hunger levels. These positive outcomes support the potential of setmelanotide as an effective treatment for hypothalamic obesity and pave the way for further studies in the ongoing Phase 3 trial.
Read Announcement- Drug:
- Setmelanotide (HO)
- Announced Date:
- April 29, 2024
- Estimated Event Date Range:
- April 1, 2025 - June 30, 2025
- Target Action Date:
- Q2 - 2025
- Indication:
- Hypothalamic Obesity
Announcement
Rhythm Pharmaceuticals, Inc. announced that the Topline data from ongoing pivotal Phase 3 clinical trial in hypothalamic obesity on track for 2Q 2025 -
AI Summary
Rhythm Pharmaceuticals, Inc. recently announced that topline data from its ongoing pivotal Phase 3 clinical trial for setmelanotide in treating hypothalamic obesity is on track for the second quarter of 2025. The study is designed to evaluate how the drug can help patients who develop rapid, severe weight gain and increased hunger due to damage to the hypothalamus. This trial builds on earlier results where setmelanotide demonstrated a notable reduction in body mass index (BMI) in patients. In previous phases, participants experienced a 15% reduction in BMI at 16 weeks and a 26% reduction after one year of treatment. The Phase 3 trial aims to further confirm these promising results while assessing long-term safety and efficacy, potentially establishing setmelanotide as a novel treatment option for individuals with hypothalamic obesity.
Read Announcement
