ObesityPhase 2NCT00746824
A Study to Determine the Effects of TM30339 on Weight Loss in Obese Individuals.
A Phase 2 study of Obesity, run by 7TM Pharma A/S.
Trial summary
The purpose of this study is to determine the effects of TM30339 on weight loss in obese individuals after 28 days dosing. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Mar 2009
- Phase
- Phase 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Obese males and females with a BMI of 30-40 kg/m2 inclusive and weight in the range of 85 - 135 kg inclusive
- Age 18-60 years inclusive
- Stable lifestyle e.g. smoking, exercise and eating patterns and times for at least 6 months, and willing to maintain these habits during the course of the study
- Stable weight over past 2 months i.e. a change in body weight < 3 kg as reported by the subject
Who cannot join
- Subjects with a history of allergies toward products containing natural rubber (e.g. latex)
- Subjects with, or with a history of, any clinically significant neurological, gastrointestinal (including bariatric surgery), renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological, or other major disorders
- Subjects who have a supine blood pressure at screening or Visit 1 higher than 150/95 mmHg by repeat measurements within 15 minutes
- Subjects who have a QTc (Bazett's correction) interval of > 450 msec at screening
- Subjects with bradycardia (heart rate < 50)
- Subjects with heart block
- Clinically significant thyroid dysfunction as evidenced by TSH > 1.5 X ULN
About this study
Official title: TM30339: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel, Repeated Subcutaneous Dose-range Study Designed to Determine the Weight Loss in Obese Subjects.
The purpose of this study is to determine the effects of TM30339 on weight loss in obese individuals after 28 days dosing.
Read the detailed description
Obesity is a disease with large socioeconomic consequences and many serious health consequences including Type 2 diabetes, dyslipidemia and cardiovascular diseases. The prevalence of obesity is increasing both in developed and developing countries. There is a great need for further medicinal treatments that effectively will support life style changes or surgical procedures in reducing or maintaining bodyweight.
7TM Pharma has identified TM30339 as a clinical development candidate molecule with potential to assist in the control and amelioration of obesity in humans.
- Conditions
- Obesity
- Being tested
- TM30339 and/or placebo
- Keywords
- Obesity, weight loss, 7TM Pharma, TM30339, Y4 receptor antagonist
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TM30339 and/or placeboDrug
Also called 30339
The drug and/or placebo will be injected in the abdominal area (site to vary for each injection). Injections will be administered twice daily for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AM dose: 0.85 mg
PM dose: placebo Receives: Drug: TM30339 and/or placebo |
| 2 | Experimental | AM dose: 0.85 mg
PM dose: 0.85 mg Receives: Drug: TM30339 and/or placebo |
| 3 | Experimental | AM dose: 2.55 mg
PM dose: placebo Receives: Drug: TM30339 and/or placebo |
| 4 | Experimental | AM dose: placebo
PM dose: 2.55 mg Receives: Drug: TM30339 and/or placebo |
| 5 | Experimental | AM dose: 2.55 mg
PM dose: 2.55 mg Receives: Drug: TM30339 and/or placebo |
| 6 | Experimental | AM dose: placebo
PM dose: placebo Receives: Drug: TM30339 and/or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the change in body weight from baseline (Visit 1) to Visit 5 (the 29th day),which will be computed for each patient and then averaged for each dose arm.
Measured: Visit 5 (the 29th day)
Secondary outcomes (4)
To determine the effects of TM30339 after 28 days dosing of obese individuals on: Waist, hip, and waist/hip ratio
Measured: Visit 5 (the 29th day)
To determine the effects of TM30339 after 28 days dosing of obese individuals on fasting glucose and insulin, and insulin sensitivity index
Measured: Visit 5 (the 29th day)
To determine the effects of TM30339 after 28 days dosing of obese individuals on formation of antibodies towards the drug, TM30339
Measured: Visit 5 (the 29th day)
To determine the effects of TM30339 after 28 days dosing of obese individuals on safety and tolerability
Measured: Visit 5 (the 29th day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionJan 2009
- Study completionMar 2009
Why it stopped: The IND was withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- 7TM Pharma A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746824
- Sponsor's protocol ID
- 2022
- Status last verified
- Aug 2012
- First submitted
- 27 Aug 2008
- Last updated
- 3 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TM30339: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel, Repeated Subcutaneous Dose-range Study Designed to Determine the Weight Loss in Obese Subjects.
- ClinicalTrials.gov ID
- NCT00746824
- Acronym / sponsor ID
- 2022
- Conditions
- Obesity
- Keywords
- Obesity, weight loss, 7TM Pharma, TM30339, Y4 receptor antagonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The IND was withdrawn.
- Enrolment
- 192 participants (actual)
- Lead sponsor
- 7TM Pharma A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 4 Sep 2008 (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.
The purpose of this study is to determine the effects of TM30339 on weight loss in obese individuals after 28 days dosing.
Detailed description
Obesity is a disease with large socioeconomic consequences and many serious health consequences including Type 2 diabetes, dyslipidemia and cardiovascular diseases. The prevalence of obesity is increasing both in developed and developing countries. There is a great need for further medicinal treatments that effectively will support life style changes or surgical procedures in reducing or maintaining bodyweight.
7TM Pharma has identified TM30339 as a clinical development candidate molecule with potential to assist in the control and amelioration of obesity in humans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TM30339 and/or placeboAM dose: 0.85 mg PM dose: placebo |
| 2 | Experimental | Drug: TM30339 and/or placeboAM dose: 0.85 mg PM dose: 0.85 mg |
| 3 | Experimental | Drug: TM30339 and/or placeboAM dose: 2.55 mg PM dose: placebo |
| 4 | Experimental | Drug: TM30339 and/or placeboAM dose: placebo PM dose: 2.55 mg |
| 5 | Experimental | Drug: TM30339 and/or placeboAM dose: 2.55 mg PM dose: 2.55 mg |
| 6 | Experimental | Drug: TM30339 and/or placeboAM dose: placebo PM dose: placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Obese males and females with a BMI of 30-40 kg/m2 inclusive and weight in the range of 85 - 135 kg inclusive
- Age 18-60 years inclusive
- Stable lifestyle e.g. smoking, exercise and eating patterns and times for at least 6 months, and willing to maintain these habits during the course of the study
- Stable weight over past 2 months i.e. a change in body weight < 3 kg as reported by the subject
Key exclusion criteria (7 listed)
- Subjects with a history of allergies toward products containing natural rubber (e.g. latex)
- Subjects with, or with a history of, any clinically significant neurological, gastrointestinal (including bariatric surgery), renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological, or other major disorders
- Subjects who have a supine blood pressure at screening or Visit 1 higher than 150/95 mmHg by repeat measurements within 15 minutes
- Subjects who have a QTc (Bazett's correction) interval of > 450 msec at screening
- Subjects with bradycardia (heart rate < 50)
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 |
|---|---|---|
| TM30339 and/or placeboAlso: 30339The drug and/or placebo will be injected in the abdominal area (site to vary for each injection). Injections will be administered twice daily for 28 days. | Drug | 1, 2, 3, 4, 5, 6 |
Primary outcome
The primary endpoint is the change in body weight from baseline (Visit 1) to Visit 5 (the 29th day),which will be computed for each patient and then averaged for each dose arm.
Time frame: Visit 5 (the 29th day)
4 secondary outcomes
To determine the effects of TM30339 after 28 days dosing of obese individuals on: Waist, hip, and waist/hip ratio
Time frame: Visit 5 (the 29th day)
To determine the effects of TM30339 after 28 days dosing of obese individuals on fasting glucose and insulin, and insulin sensitivity index
Time frame: Visit 5 (the 29th day)
To determine the effects of TM30339 after 28 days dosing of obese individuals on formation of antibodies towards the drug, TM30339
Time frame: Visit 5 (the 29th day)
To determine the effects of TM30339 after 28 days dosing of obese individuals on safety and tolerability
Time frame: Visit 5 (the 29th day)
Results and safety
The study was stopped early (reason given: The IND was withdrawn.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2012.
- 7TM Pharma websiteLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Obesity, run by 7TM Pharma A/S.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 3 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
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 was stopped early (reason given: The IND was withdrawn.). Results are not available in the source record.
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?
The primary endpoint is the change in body weight from baseline (Visit 1) to Visit 5 (the 29th day),which will be computed for each patient and then averaged for each dose arm. (time frame: Visit 5 (the 29th day)). 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 3 Sep 2012.