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Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome

G

Gedeon Richter

Status and phase

Completed
Phase 2

Conditions

Prader-Willi Syndrome

Treatments

Drug: RGH-706
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05322096
RGH-706-003
2021-004262-35 (EudraCT Number)

Details and patient eligibility

About

RGH-706 is a novel, potent, and orally active MCHR1 antagonist drug candidate discovered and being developed by Gedeon Richter Plc. for weight management.

This will be the first Phase 2, proof-of-concept study using RGH-706 and is the third study in the clinical development program for RGH-706. The aim of this study is to evaluate the efficacy, safety, and tolerability of RGH-706 in patients with Prader-Willi Syndrome (PWS).

Enrollment

39 patients

Sex

All

Ages

17+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Age Limits:

  • In United States (USA), minimum age will be 17 years old.
  • In European Union (EU) countries, minimum age will be 18 years old.

Inclusion Criteria:

  • Male or female patients aged ≥17 years in USA at screening or aged ≥18 years in EU at screening
  • Genetically confirmed diagnosis of PWS
  • HQ-CT total score ≥14 at screening
  • Body weight ≥40 kg/88 lbs and ≤200 kg/450 lbs
  • Stable body weight
  • Negative pregnancy test for females of childbearing potential and nonlactating at screening.
  • Patients must be able to provide or have a parent or guardian who is able to provide written informed consent and/or assent (as applicable)
  • Patients must have at least 1 consistent and reliable primary caregiver

Exclusion Criteria:

  • Severe psychiatric disorders (eg, schizophrenia, bipolar disorder, or major depressive disorder), recent (within 6 months)
  • Risk of suicide according to the investigator's judgment
  • Uncontrollable diabetes mellitus or diabetes mellitus requiring insulin administration
  • Poorly controlled hypothyroidism or hyperthyroidism
  • Chronic or acute liver disease
  • History of bariatric surgery procedure
  • Uncontrolled obstructive sleep apnea.
  • History of malignancy within 5 years of screening
  • Systolic blood pressure (BP) ≥160 mmHg and/or diastolic BP ≥100 mmHg, pulse rate ≥100/min at screening.
  • Use of weight-lowering pharmacotherapy within 6 months prior to screening.
  • Known QT prolongation
  • Clinically relevant laboratory abnormalities
  • Any other condition that, in the investigator's opinion, might indicate that the patient is unsuitable for the study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

39 participants in 2 patient groups, including a placebo group

RGH-706
Experimental group
Description:
Dose A once daily for 6 weeks
Treatment:
Drug: RGH-706
Placebo
Placebo Comparator group
Description:
Placebo once daily for 6 weeks
Treatment:
Drug: Placebo

Trial contacts and locations

23

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Central trial contact

Medical Information Scientific Service

Data sourced from clinicaltrials.gov

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