The TEMPO (Tracing the Effect of the MC4 Pathway in Obesity) Registry

Completed

Conditions studied: Genetic Forms of Extreme Obesity

In brief

A voluntary prospective study that will allow registration and follow-up of individuals with MC4R pathway genetic obesity.

Key facts

Study ID

NCT03479437

Run by

Rhythm Pharmaceuticals, Inc.

People needed

303

Starts

2018-04-15

Expected to finish

2020-12-01

Last updated by the study team

2021-05-04

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Extreme obesity patients aged 2 years and older.
• Extreme obesity defined as:
• BMI > 40 kg/m2 in patients 18 years of age or older.
• BMI value that is >1.4 times the corresponding age/gender 95th percentile value in patients who are 2 through 17 years of age.
• At least one of the following genotypes:
• Bi-allelic (homozygous or compound heterozygous) POMC, PCSK1, LEPR variants leading to the physician-confirmed diagnosis of either POMC or LEPR deficiency obesity.
• The presence of high-confidence, high-impact genetic variations (homozygote, compound heterozygote, heterozygote or composite heterozygote [i.e., heterozygous variants in more than a single gene]) in these same 3 genes (POMC, PCSK1 and LEPR) associated with the clinical presentation of extreme obesity
• The presence of other high-confidence, high-impact genetic variations (homozygote, compound heterozygote, heterozygote or composite heterozygote in the MC4R gene or other upstream MC4R-pathway genes and selected variants downstream in the MC4R-pathway (Table 1) that are carried by extreme obesity patients who do not demonstrate specific syndromic obesity clinical presentations. Selected Bardet-Biedl syndrome (BBS1 through BBS21) genetic variants or Alström syndrome (ALMS) genetic variants possibly contributing to non-syndromic forms of clinical extreme obesity will be eligible for enrollment.
• Study participant and/or parent or caregiver can understand and comply with the requirements of the study, and able to understand and sign the written informed consent (IC)/assent, after being informed about the study.

You may not qualify if…

• Patients with syndromic forms of obesity such as Bardet-Biedl syndrome or Alström syndrome. These patients will be referred to existing registries for these specific syndromic obesity (e.g., Clinical Registry in Bardet-Biedl syndrome [CRIBBS] for BBS patients).
• Individual is, in the opinion of the study investigator, not suitable to participate in the study.

Where it is running

• Nationwide Children's Hospital — Columbus, Ohio, United States
• University of Alberta — Edmonton, Canada

Full record on ClinicalTrials.gov

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