Obesity, ChildhoodWEGIONCT06239064
Early Genetic Identification of Obesity
An observational study of Obesity, Childhood and Hyperphagia, run by Rolfs Consulting und Verwaltungs-GmbH (RCV) at 37 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Obesity, Childhood, Hyperphagia, Retinopathy
- What is being tested?
- Genetic testing via blood collection
- How many people
- 1,000 participants
- Where
- 37 sitesGermany
- Study dates
- 24 Jan 2024to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Child, Adult, Older adult
Study population: Participants at risk for a syndromic or a monogenic genetic obesity, incl. participants clinically diagnosed with Bardet-Biedl-Syndrome (BBS)
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- Not fulfilling the inclusion criteria
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
Germany37 sites
Universitätsklinikum Aachen (RWTH)
Aachen, 52074
KJF Klinik Josefinum
Augsburg, 86154
Universitätsklinikum Augsburg - Klinik für Kinder- und Jugendmedizin
Augsburg, 86156
Universitätsklinikum Freiburg
Bad Krozingen, 79189
Klinikum Bielefeld Mitte
Bielefeld, 33604
Universitätsklinikum Bonn
Bonn, 53127
Praxis für Endokrinologie Dr. Daniel Pfaff
Bückeburg, 31675
Cellitinnen-Krankenkaus St. Franziskus
Cologne, 50825
Universitätsmedizin Essen
Essen, 45147
Klinikum Frankfurt (Oder)
Frankfurt (Oder), 15236
SRH Wald-Klinikum Gera
Gera, 07548
Universitätsmedizin Göttingen - Klinik für Kinder- und Jugendmedizin
Göttingen, 37075
WolfartKlinik
Gräfelfing, 82166
Universitätsmedizin Greifswald - Klinik und Poliklinik für Innere Medizin A
Greifswald, 17475
Katholisches Kinderkrankenhaus WILHELMSTIFT
Hamburg, 22149
Kinder- und Jugendkrankenhaus Auf der Bult
Hanover, 30173
Hormonzentrum Heidelberg
Heidelberg, 69115
Kinder- und Jugendarztpraxis Nebras Mohammad
Iserlohn, 58636
Universitätsklinikum Jena
Jena, 07747
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel, 24105
Sozialpädiatrisches Zentrum Leipzig
Leipzig, 04129
Universitätsmedizin Mannheim - Augenklinik
Mannheim, 68167
Städtische Kliniken Mönchengladbach - Elisabeth-Krankenhaus Rheydt
Mönchengladbach, 41239
Kinder- und Jugendarztpraxis Sulaiman Al Sawaf
Nettetal, 41334
Dietrich-Bonhoeffer-Klinikum
Neubrandenburg, 17036
Hausarztpraxis Rahman & Detho
Obertshausen, 63179
Sana Klinikum Offenbach
Offenbach, 63069
Kinderärzte am Leo
Pforzheim, 75172
Klinikum Ernst von Bergmann
Potsdam, 14467
Elblandklinikum Riesa
Riesa, 01589
GPR Klinikum Rüsselsheim
Rüsselsheim am Main, 65428
Kinder- und Jugendpraxis Dogan
Stuttgart, 70178
SRH Zentralklinikum Suhl GmbH
Suhl, 98527
Praxis für Kinder- und Jugendmedizin Dr. med. Tabea Tippelt
Velbert, 42551
Dreifaltigkeits-Krankenhaus Wesseling
Wesseling, 50389
Praxis für Kinder- und Jugendmedizin Seyfullah Gökce
Wiesbaden, 65185
Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik I
Würzburg, 97080
About this study
Official title: Whole Genetic Approach in Early Genetic Identification of Obesity (WEGIO)
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
- Conditions
- Obesity, Childhood, Hyperphagia, Retinopathy, Syndactyly, Polydactyly, Cognitive Impairment
- Being tested
- Genetic testing via blood collection
- Keywords
- Early onset obesity, Hyperphagia, Genetics, Bardet-Biedl Syndrome, LEPR, POMC, PCSK1
- Medical subject headings
- Pediatric Obesity, Hyperphagia, Retinal Diseases, Syndactyly, Polydactyly, Cognitive Dysfunction, Bardet-Biedl Syndrome, Proopiomelanocortin Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic testing via blood collectionDiagnostic test
blood collection
| Study group | Role | What they receive |
|---|---|---|
| Participants suspected to genetic obesity | Participants suspected to genetic obesity Receives: Diagnostic Test: Genetic testing via blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
BBS prevalence
To investigate the prevalence of BBS in patients suspected to a genetic obesity
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start24 Jan 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rolfs Consulting und Verwaltungs-GmbH (RCV)
- Sponsor type
- Research network
- Collaborators
- Rhythm Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Arndt Rolfs, PhD, MD, Study chair, Rolfs Consulting und Verwaltungs-GmbH (RCV)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239064
- Sponsor's protocol ID
- WEGIO 01-2023
- Acronym
- WEGIO
- Status last verified
- Feb 2025
- First submitted
- 25 Jan 2024
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Genetic Approach in Early Genetic Identification of Obesity (WEGIO)
- ClinicalTrials.gov ID
- NCT06239064
- Acronym / sponsor ID
- WEGIO / WEGIO 01-2023
- Conditions
- Obesity, Childhood, Hyperphagia, Retinopathy, Syndactyly, Polydactyly, Cognitive Impairment
- Keywords
- Early onset obesity, Hyperphagia, Genetics, Bardet-Biedl Syndrome, LEPR, POMC, PCSK1
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Rolfs Consulting und Verwaltungs-GmbH (RCV)Research network
- Collaborators
- Rhythm Pharmaceuticals, Inc.
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants suspected to genetic obesity | – | Diagnostic Test: Genetic testing via blood collectionParticipants suspected to genetic obesity |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Participants at risk for a syndromic or a monogenic genetic obesity, incl. participants clinically diagnosed with Bardet-Biedl-Syndrome (BBS)
Key inclusion criteria (11 listed)
- Informed consent is obtained from the participant/parent/legal guardian
- The participant is 2 years of age or older
- 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
Key exclusion criteria (1 listed)
- Not fulfilling the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic testing via blood collectionblood collection | Diagnostic test | Participants suspected to genetic obesity |
Primary outcome
BBS prevalence
Time frame: 2 years
To investigate the prevalence of BBS in patients suspected to a genetic obesity
1 secondary outcome
Phenotypic and genetic characterization
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arndt Rolfs, PhD, MD study chair
Rolfs Consulting und Verwaltungs-GmbH (RCV)
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Childhood and Hyperphagia, run by Rolfs Consulting und Verwaltungs-GmbH (RCV) at 37 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BBS prevalence (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.