Anti Obesity AgentPhase 1/2NCT00822705
Inhibition of Food Intake in Response to Oral GLP-1 and Peptide YY3-36
A Phase 1/2 study of Anti Obesity Agent, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Interaction of GLP-1 and PYY3-36 in the inhibition of food intake in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anti Obesity Agent
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2008to Jan 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male subjects
- no evidence of disease
- no history of gastrointestinal or endocrine disorders
Who cannot join
- alcohol and drug abuse
- history of gastrointestinal or endocrine disorders
- female subjects
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinical Research Center, University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Inhibition of Food Intake in Response to Oral GLP-1 and Peptide YY3-36: a Phase 1 Study
Interaction of GLP-1 and PYY3-36 in the inhibition of food intake in healthy subjects
Read the detailed description
PYY3-36 and GLP-1 are two classical gastrointestinal peptides, which are released into the circulation during meals from L-cells of the distal gut; there is compelling evidence that each participates in the control of appetite regulating individual meal sizes in healthy subjects, but also in patients with obesity or diabetes type II. The regulation of human eating habits is, however, highly complex and our understanding of appetite control is far from complete. In many areas our knowledge is rather rudimentary; little is known, to give an example, about the importance of individual signals and their interactions.
From studies in animals and humans it is known that individual satiety signals can interact: contributions of glucagon and CCK produced functionally synergistic inhibitions of feeding in rats, that is, simultaneous injection of the two peptides inhibited feeding significantly more than the sum of their individual effects. In contrast, we have been unable to show in healthy volunteers any interaction between GLP-1 and CCK33; the simultaneous infusion of CCK33 and GLP-1 resulted in an infra-additive reduction in meal size, which led us to suggest that the two peptides could even interact antagonistically.
To further explore potential interactions between these two well-known satiety signals, we plan to investigate the effects of individual doses of PYY3-36 and GLP-1, and their interaction in the control of food intake and satiety in healthy male subjects.
- Conditions
- Anti Obesity Agent
- Being tested
- Placebo tablet
- Keywords
- Appetite, energy consumption, gastrointestinal hormones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo tabletDrug
Control arm
| Study group | Role | What they receive |
|---|---|---|
| ORAL GLP-1, TABLET | Active comparator | Not described Receives: Drug: Placebo tablet |
| Oral PYY3-36 | Active comparator | Not described Receives: Drug: Placebo tablet |
| Oral GLP-1 plus oral PYY3-36 | Active comparator | Not described Receives: Drug: Placebo tablet |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy consumption
Measured: 1 hour food consumption
Secondary outcomes (1)
Appetite feelings, plasma kinetics adverse events
Measured: adeverse events during study (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startAug 2008
- Primary completionNov 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anti Obesity AgentStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- CHRISTOPH BEGLINGER, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822705
- Sponsor's protocol ID
- EKBB 127/07
- Other IDs
- SNF grant 320000-118330
- Status last verified
- Jan 2009
- First submitted
- 13 Jan 2009
- Last updated
- 14 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Steinert RE, Poller B, Castelli MC, Drewe J, Beglinger C. Oral administration of glucagon-like peptide 1 or peptide YY 3-36 affects food intake in healthy male subjects. Am J Clin Nutr. 2010 Oct;92(4):810-7. doi: 10.3945/ajcn.2010.29663. Epub 2010 Aug 18.
PubMed 20720259
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhibition of Food Intake in Response to Oral GLP-1 and Peptide YY3-36: a Phase 1 Study
- ClinicalTrials.gov ID
- NCT00822705
- Acronym / sponsor ID
- EKBB 127/07
- Conditions
- Anti Obesity Agent
- Keywords
- Appetite, energy consumption, gastrointestinal hormones
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 14 Jan 2009 (estimated)
- 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.
Interaction of GLP-1 and PYY3-36 in the inhibition of food intake in healthy subjects
Detailed description
PYY3-36 and GLP-1 are two classical gastrointestinal peptides, which are released into the circulation during meals from L-cells of the distal gut; there is compelling evidence that each participates in the control of appetite regulating individual meal sizes in healthy subjects, but also in patients with obesity or diabetes type II. The regulation of human eating habits is, however, highly complex and our understanding of appetite control is far from complete. In many areas our knowledge is rather rudimentary; little is known, to give an example, about the importance of individual signals and their interactions.
From studies in animals and humans it is known that individual satiety signals can interact: contributions of glucagon and CCK produced functionally synergistic inhibitions of feeding in rats, that is, simultaneous injection of the two peptides inhibited feeding significantly more than the sum of their individual effects. In contrast, we have been unable to show in healthy volunteers any interaction between GLP-1 and CCK33; the simultaneous infusion of CCK33 and GLP-1 resulted in an infra-additive reduction in meal size, which led us to suggest that the two peptides could even interact antagonistically.
To further explore potential interactions between these two well-known satiety signals, we plan to investigate the effects of individual doses of PYY3-36 and GLP-1, and their interaction in the control of food intake and satiety in healthy male subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ORAL GLP-1, TABLET | Active comparator | Drug: Placebo tablet |
| Oral PYY3-36 | Active comparator | Drug: Placebo tablet |
| Oral GLP-1 plus oral PYY3-36 | Active comparator | Drug: Placebo tablet |
| 4 | Placebo comparator | Drug: Placebo tablet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy male subjects
- no evidence of disease
- no history of gastrointestinal or endocrine disorders
Key exclusion criteria (3 listed)
- alcohol and drug abuse
- history of gastrointestinal or endocrine disorders
- female subjects
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 |
|---|---|---|
| Placebo tabletControl arm | Drug | 4, ORAL GLP-1, TABLET, Oral GLP-1 plus oral PYY3-36, Oral PYY3-36 |
Primary outcome
Energy consumption
Time frame: 1 hour food consumption
1 secondary outcome
Appetite feelings, plasma kinetics adverse events
Time frame: adeverse events during study (3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2009.
- Derived from this study: PubMed 20720259Steinert RE, Poller B, Castelli MC, Drewe J, Beglinger C. Oral administration of glucagon-like peptide 1 or peptide YY 3-36 affects food intake in healthy male subjects. Am J Clin Nutr. 2010 Oct;92(4):810-7. doi: 10.3945/ajcn.2010.29663. Epub 2010 Aug 18.
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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.
CHRISTOPH BEGLINGER, MD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study of Anti Obesity Agent, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 14 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Energy consumption (time frame: 1 hour food consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00822705, which also lists 1 linked publication.
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 14 Jan 2009.