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RM-718 (Cohort A2) for Hypothalamic Obesity

Q: Are prospective patients still eligible to participate in this ongoing medical study?

According to the details on clinicaltrials.gov, this research is actively enrolling subjects. The trial was first listed on 28th February 2024 and last revised on 15th February 2024.

Q: What is the current number of participants being recruited for this medical study?

Indeed, the details provided on clinicaltrials.gov affirm that this research project is actively seeking volunteers. Initially uploaded on February 28th, 2024, and subsequently updated by February 15th of the same year, the investigation aims to enroll a total of 90 participants at one designated site.

Q: What is the level of safety associated with RM-718 (Cohort A2) in individuals?

According to our assessment at Power, we have assigned a safety rating of 1 to RM-718 (Cohort A2) as it is currently in Phase 1 trial stage with scarce evidence backing its safety and effectiveness.

Q: Which individuals are eligible to participate in this clinical research study?

In this clinical study, inclusion criteria encompass enrolling 90 individuals aged between 12 and 65 who are grappling with hypothalamic <a href="https://www.withpower.com/clinical-trials/obesity">obesity</a>. Patients must meet the subsequent conditions: Both male and female participants in sound health within the age range of 18-55 at the time of screening., An elevated body mass index (BMI) equal to or greater than 30 kg/m2., Individuals exhibiting good overall health status with either normal or clinically insignificant findings during initial screenings., Strict adherence to a highly efficient contraception method alongside compliance with designated contraceptive protocols throughout the trial period., Male and female subjects diagnosed with hypothalamic obesity, aged from

Q: Is the research study open to individuals who are above 60 years old?

The eligibility criteria specify an age range of 12 to 65 years for potential participants in this clinical study. There are a total of 178 studies targeting individuals under the age of 18 and 619 focused on those over the age of 65.

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

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).

Awards & highlights

Study Summary

This trial aims to test the safety, side effects, and how the body processes RM-718 in both healthy individuals with obesity and patients with a specific type of obesity called hypothalamic obesity.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Parts A, B, C: Safety and Tolerability Assessed by Number of Study Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Secondary outcome measures

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