ClinicalTrials.gg
Active, not recruitingNCT06239064WEGIOUpdated Sep 29, 2025

Early Genetic Identification of Obesity

An observational study in Obesity, Childhood, Hyperphagia and Retinopathy, sponsored by Rolfs Consulting und Verwaltungs-GmbH (RCV). Active, not recruiting at 37 sites in Germany. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2025-09-29.

Sponsored by Rolfs Consulting und Verwaltungs-GmbH (RCV) · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 8 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
2 Years and older
Sex
All
01

Study summary

TITLE: Whole genetic approach in Early Genetic Identification of Obesity (WEGIO)

DESIGN: Multicenter epidemiological study

STUDY POPULATION: Participants at risk for a syndromic or a monogenic genetic obesity, incl. participants clinically diagnosed with Bardet-Biedl-Syndrome (BBS)

NUMBER OF PARTICIPANTS: 1000 for initial genetic sequencing and app. 40 for the follow-up documentation

COORDINATING INVESTIGATOR: Prof. Dr. Arndt Rolfs

Read the detailed description

TITLE: Whole genetic approach in Early Genetic Identification of Obesity (WEGIO)

DESIGN: Multicenter epidemiological study

STUDY POPULATION: Participants at risk for a syndromic or a monogenic genetic obesity, incl. participants clinically diagnosed with Bardet-Biedl-Syndrome (BBS)

NUMBER OF PARTICIPANTS: 1000 for initial genetic sequencing and app. 40 for the follow-up documentation

COORDINATING INVESTIGATOR: Prof. Dr. Arndt Rolfs

PARTICIPATING COUNTRY: Germany

TREATMENT: Not applicable

PRIMARY OBJECTIVE: To investigate the prevalence of BBS in an at-risk population

SECONDARY OBJECTIVES:

  • To explore genotype-phenotype correlation
  • To assess genotypes distribution in Germany and compare to other countries
  • To identify new genes/variants
  • To investigate clinical characteristics in individuals diagnosed with BBS

DURATION OF RECRUITMENT: 32 months - total

24 months the recruitment of 1000 subjects

27 months follow up visits

32 months close out of sites

INCLUSION CRITERIA:

  • Informed consent is obtained from the participant/parent/legal guardian
  • The participant is 2 years of age or older

For a participant between 2 and 18 years of age:

  • The participant has and had a body weight more than 97th percentile before the age of 6
  • The participant has one or more of the following symptoms:

rod/cone dystrophy, renal abnormalities, ataxia, syndactyly, polydactyly, brachydactyly, hyperphagia, cognitive impairment, speech delay, hypogonadism

For a participant who is 18 years of age or older:

  • The participant has BMI ≥ 30 kg/m2
  • The participant had a body weight more than 97th percentile before the age of 6 years
  • The participant has rod/cone dystrophy
  • The participant is 2 or more years of age, is clinically diagnosed with Bardet-Biedl-Syndrome (BBS) or is a sibling of an individual diagnosed with BBS via the WEGIO study
02

Conditions studied

  • Obesity, Childhood
  • Hyperphagia
  • Retinopathy
  • Syndactyly
  • Polydactyly
  • Cognitive Impairment
  • Bardet-Biedl Syndrome
  • POMC Deficiency

Keywords

  • Early onset obesity
  • Hyperphagia
  • Genetics
  • Bardet-Biedl Syndrome
  • LEPR
  • POMC
  • PCSK1
03

In context

Pediatric Obesity

1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 180 across 235 observational studies indexed under Pediatric Obesity.

Browse Pediatric Obesity studies →

Lead sponsor

This is the only study on the registry with Rolfs Consulting und Verwaltungs-GmbH (RCV) as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Participants at risk for a syndromic or a monogenic genetic obesity, incl. participants clinically diagnosed with Bardet-Biedl-Syndrome (BBS)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • is obtained from the participant/parent/legal guardian
  • The participant is 2 years of age or older

For a participant between 2 and 18 years of age:

  • The participant has and had a body weight more than 97th percentile before the age of 6
  • The participant has one or more of the following symptoms:

rod/cone dystrophy, renal abnormalities, ataxia, syndactyly, polydactyly, brachydactyly, hyperphagia, cognitive impairment, speech delay, hypogonadism

For a participant who is 18 years of age or older:

  • The participant has ≥ 30 kg/m2
  • The participant had a body weight more than 97th percentile before the age of 6 years
  • The participant has rod/cone dystrophy
  • The participant is 2 or more years of age, is clinically diagnosed with Bardet-Biedl-Syndrome (BBS) or is a sibling of an individual diagnosed with BBS via the WEGIO study

Exclusion criteria

Exclusion criteria:

- Not fulfilling the inclusion criteria

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Participants suspected to genetic obesity

    Participants suspected to genetic obesity

    Diagnostic Test: Genetic testing via blood collection

Interventions

  • Diagnostic testGenetic testing via blood collection

    blood collection

06

What researchers measure

Primary outcomes

  1. BBS prevalence

    To investigate the prevalence of BBS in patients suspected to a genetic obesity

    Time frame: 2 years

Secondary outcomes

  1. Phenotypic and genetic characterization

    To understand the genotype-phenotype correlation; to assess genotypes distribution in Germany and compare to other countries; to identify new genes/variants; to investigate clinical characteristics in individuals diagnosed with BBS

    Time frame: 2 years

07

Study locations

37 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2024 (actual). Primary completion is estimated for Mar 2026, 25 months after the start.

Of 94 non-industry observational studies under Pediatric Obesity, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 132. This study's planned 25 months is below that.

Counting every sponsor, half of 96 studies reached it within 52 months; a quarter within 21 and three quarters within 132.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 25, 2024
First posted
Feb 2, 2024
StartActual
Jan 24, 2024
Primary completionEst.
Mar 1, 2026
CompletionEst.
Mar 1, 2027
Last update
Sep 29, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06239064
Lead sponsor
Rolfs Consulting und Verwaltungs-GmbH (RCV)
Responsible party
Sponsor
First posted
Feb 2, 2024
Start date
Jan 24, 2024
Primary completion
Mar 1, 2026 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Sep 29, 2025

Study contacts

Arndt Rolfs, PhD, MD
study chair · Rolfs Consulting und Verwaltungs-GmbH (RCV)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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