What is the mechanism of action of this treatment?

Common treatments for Hypothalamic Obesity (HO) often target metabolic and hormonal pathways to manage or reduce obesity. These include GLP-1 receptor agonists, which enhance insulin secretion, inhibit glucagon release, and slow gastric emptying, leading to reduced appetite and increased satiety. Combination drugs like phentermine-topiramate also play a role by suppressing appetite and increasing energy expenditure. These mechanisms are particularly important for HO patients, whose condition is resistant to conventional weight loss methods due to disrupted hypothalamic signaling, making targeted interventions more effective.

What side effects are associated with this type of intervention?

Common treatments for Hypothalamic Obesity that target metabolic and hormonal pathways include metformin, GLP-1 receptor agonists like liraglutide and semaglutide, and other weight loss medications. Metformin is generally well-tolerated but can cause gastrointestinal issues such as nausea, diarrhea, and abdominal discomfort. GLP-1 receptor agonists are effective for weight loss and glycemic control but may lead to side effects like nausea, vomiting, and potential injection site reactions. Other weight loss drugs, such as topiramate and naltrexone/bupropion, can cause side effects including dizziness, dry mouth, insomnia, and increased heart rate. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

There are no specific FDA-approved treatments exclusively for hypothalamic obesity (HO). However, drugs targeting metabolic and hormonal pathways, such as GLP-1 receptor agonists (e.g., liraglutide, semaglutide), have been approved for general obesity management and may offer potential benefits for HO. These medications work by enhancing insulin secretion, reducing appetite, and promoting weight loss. Other drugs like metformin and topiramate, which influence metabolic processes, are also used to manage weight in various conditions and could be considered in the context of HO.

What other types of research exist?

Promising alternatives to RM-718 for hypothalamic obesity patients include ghrelin receptor antagonists, GLP-1 receptor agonists (such as liraglutide and semaglutide), and dual GIP and GLP-1 receptor agonists (such as tirzepatide). These therapies target metabolic and hormonal pathways to manage or reduce obesity.

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RM-718 for Hypothalamic Obesity

Phase 1

Recruiting

Research Sponsored by Rhythm Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to communicate with the Investigator, understand and comply with the requirements of the trial, and understand and sign the written informed consent and assent for patients aged <18 years and informed consent for a parent or guardian of any patient <18

Parts A and B: Male and female subjects in good health aged 18-55 years at Screening with BMI ≥30 kg/m2

Must not have

Obesity due to genetic, syndromic, or endocrine etiologies

History of renal transplant, end stage renal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 168 hours post-dose on day 1 (parts a, b and c) and 168 hours post-dose on day 22 (parts b and c).

Summary

This trial tests RM-718, an injection, in adults with obesity and patients with hypothalamic obesity. It aims to check if the drug is safe and how well people can tolerate it.

Who is the study for?

This trial is for adults aged 18-55 with obesity (BMI ≥30 kg/m2) and patients aged 12-65 with hypothalamic obesity due to brain lesions or injury. Participants must be in good health, able to follow the study's requirements, use effective contraception, and provide informed consent.

What is being tested?

The study tests RM-718's safety, tolerability, and pharmacokinetics (PK). It has three parts: A & B involve comparing RM-718 with a placebo in healthy obese subjects; Part C administers RM-718 to patients with hypothalamic obesity.

What are the potential side effects?

While specific side effects of RM-718 are not listed here, common side effects from new medications may include nausea, headaches, allergic reactions or skin irritation at the injection site if applicable.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can communicate well and understand the trial's requirements.

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I am between 18-55 years old, in good health, and have a BMI of 30 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My obesity is caused by genetic, syndromic, or hormonal reasons.

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I have had a kidney transplant or have end-stage kidney disease.

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I have been diagnosed with Prader-Willi syndrome or ROHHADNET.

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I have lost more than 2% of my weight in the last 3 months or am on anti-obesity medication.

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I do not have severe mental health issues or thoughts of harming myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 168 hours post-dose on day 1 (parts a, b and c) and 168 hours post-dose on day 22 (parts b and c).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 168 hours post-dose on day 1 (parts a, b and c) and 168 hours post-dose on day 22 (parts b and c).

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 168 hours post-dose on day 1 (parts a, b and c) and 168 hours post-dose on day 22 (parts b and c). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

AUCtau measurement of RM-718

Accumulation ratio of RM-718

CL/F measurement of RM-718

+9 more

Trial Design

14Treatment groups

Experimental Treatment

Group I: RM-718 (Cohort C3)Experimental Treatment1 Intervention

Multiple ascending doses of RM-718 (8)

Group II: RM-718 (Cohort C2)Experimental Treatment1 Intervention

Multiple ascending doses of RM-718 (8)

Group III: RM-718 (Cohort C1)Experimental Treatment1 Intervention

Multiple ascending doses of RM-718 (8)

Group IV: RM-718 (Cohort B5)Experimental Treatment1 Intervention

Multiple ascending doses of RM-718 (4) or placebo (2)

Group V: RM-718 (Cohort B4)Experimental Treatment1 Intervention

Multiple ascending doses of RM-718 (4) or placebo (2)

Group VI: RM-718 (Cohort B3)Experimental Treatment1 Intervention

Multiple ascending doses of RM-718 (4) or placebo (2)

Group VII: RM-718 (Cohort B2)Experimental Treatment1 Intervention

Multiple ascending doses of RM-718 (4) or placebo (2)

Group VIII: RM-718 (Cohort B1)Experimental Treatment1 Intervention

Multiple doses of RM-718 (4) or placebo (2)

Group IX: RM-718 (Cohort A6)Experimental Treatment1 Intervention