ObesityPhase 2NCT00485017
Efficacy and Safety of THR-4109 in Obese Subjects
A Phase 2 study testing THR-4109 in people with Obesity, run by Theracos at 20 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and effect of THR-4109 on weight loss in obese subjects over a 24-week treatment period. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- THR-4109
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Aug 2007to Jun 2008
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 30 to 60 years of age
- Body mass index between 30 and 40 kg/m2
- Women of child bearing potential with a negative pregnancy test prior to entry and who agree to use an acceptable method of contraception throughout the study
- Able and willing to give written informed consent
Who cannot join
- Weight loss of more than 3 kg in the previous 3 months
- Current or previous use (within 3 months) of medications that influence weight
- Known endocrine origin for obesity, such as hypothyroidism and Cushing's syndrome
- Current or history of eating disorder such as bulimia, anorexia nervosa, binge eating or laxative abuse
- Current serious/unstable medical condition
- Current pharmacologically treated diabetes or fasting plasma glucose ≥ 126 mg/dL
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
Russia17 sites
Investigational Site #62
Arkhangelsk, 163045
Investigational Site #61
Moscow, 107014
Investigational Site #51
Moscow, 117036
Investigational Site #60
Moscow, 121069
Investigational Site #57
Moscow, 123056
Investigational Site #50
Moscow, 125315
Investigational Site #54
Moscow, 129010
Investigational Site #63
Saint Petersburg, 192283
Investigational Site #67
Saint Petersburg, 194291
Investigational Site #53
Saint Petersburg, 194354
Investigational Site #66
Saint Petersburg, 194354
Investigational Site #59
Saint Petersburg, 195267
Investigational Site #65
Saint Petersburg, 197110
Investigational Site #55
Saint Petersburg, 197198
Investigational Site #58
Saint Petersburg, 198134
Investigational Site #64
Saint Petersburg, 199178
Investigational Site #56
Saratov, 410018
Sweden3 sites
Investigational Site #12
Dalby, SE-240 10
Investigational Site #11
Gothenburg, SE-411 36
Investigational Site #13
Malmö, SE-205 02
About this study
Official title: A Phase II Randomized, Double-Blind, Double-Dummy, Parallel Group, Placebo Controlled Study of THR-4109 in Obese Subjects
The purpose of this study is to evaluate the safety and effect of THR-4109 on weight loss in obese subjects over a 24-week treatment period.
- Conditions
- Obesity
- Being tested
- THR-4109, Placebo
- Keywords
- Obesity, Weight Loss
- 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.
THR-4109Drug
THR-4109 maximum dose in study is 115 mg via oral capsule daily in a.m. and 115 mg via oral capsule daily in p.m. for 24 weeks
PlaceboDrug
Oral capsules daily in a.m. and in p.m. for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | THR-4109: 115 mg orally in am, 115 mg orally in pm for 24 weeks Receives: Drug: THR-4109 |
| 2 | Experimental | THR-4109: 100 mg orally in am, 100 mg orally in pm for 24 weeks Receives: Drug: THR-4109 |
| 3 | Experimental | THR-4109: 15 mg orally in am, 15 mg orally in pm for 24 weeks Receives: Drug: THR-4109 |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline weight
Measured: 24 weeks
Secondary outcomes (3)
Proportion of subjects who achieve weight loss of at least 5% and at least 10% of baseline body weight
Measured: 24 weeks
Serum lipids, waist circumference, fasting plasma glucose and blood pressure
Measured: 24 weeks
Safety and tolerability of THR-4109
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2007 (estimated)
- Study startAug 2007
- Primary completionJun 2008
- Study completionJun 2008
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theracos
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TFS Trial Form Support
- Investigators
- Natalie J Warner, MD, Study director, Theracos, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485017
- Sponsor's protocol ID
- THR-4109-C-302
- Status last verified
- Sep 2019
- First submitted
- 8 Jun 2007
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double-Blind, Double-Dummy, Parallel Group, Placebo Controlled Study of THR-4109 in Obese Subjects
- ClinicalTrials.gov ID
- NCT00485017
- Acronym / sponsor ID
- THR-4109-C-302
- Conditions
- Obesity
- Keywords
- Obesity, Weight Loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- TheracosIndustry (pharma, biotech, devices)
- Collaborators
- TFS Trial Form Support
- Study start
- Aug 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 12 Jun 2007 (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 evaluate the safety and effect of THR-4109 on weight loss in obese subjects over a 24-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: THR-4109THR-4109: 115 mg orally in am, 115 mg orally in pm for 24 weeks |
| 2 | Experimental | Drug: THR-4109THR-4109: 100 mg orally in am, 100 mg orally in pm for 24 weeks |
| 3 | Experimental | Drug: THR-4109THR-4109: 15 mg orally in am, 15 mg orally in pm for 24 weeks |
| 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 30 to 60 years of age
- Body mass index between 30 and 40 kg/m2
- Women of child bearing potential with a negative pregnancy test prior to entry and who agree to use an acceptable method of contraception throughout the study
- Able and willing to give written informed consent
Key exclusion criteria (6 listed)
- Weight loss of more than 3 kg in the previous 3 months
- Current or previous use (within 3 months) of medications that influence weight
- Known endocrine origin for obesity, such as hypothyroidism and Cushing's syndrome
- Current or history of eating disorder such as bulimia, anorexia nervosa, binge eating or laxative abuse
- Current serious/unstable medical condition
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 |
|---|---|---|
| THR-4109THR-4109 maximum dose in study is 115 mg via oral capsule daily in a.m. and 115 mg via oral capsule daily in p.m. for 24 weeks | Drug | 1, 2, 3 |
| PlaceboOral capsules daily in a.m. and in p.m. for 24 weeks | Drug | 4 |
Primary outcome
Percent change from baseline weight
Time frame: 24 weeks
3 secondary outcomes
Proportion of subjects who achieve weight loss of at least 5% and at least 10% of baseline body weight
Time frame: 24 weeks
Serum lipids, waist circumference, fasting plasma glucose and blood pressure
Time frame: 24 weeks
Safety and tolerability of THR-4109
Time frame: 24 weeks
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 30 Sep 2019.
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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.
Natalie J Warner, MD study director
Theracos, Inc.
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing THR-4109 in people with Obesity, run by Theracos at 20 sites in 2 countries.
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 6 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 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Russia, Sweden. 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 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 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?
Percent change from baseline weight (time frame: 24 weeks). 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 30 Sep 2019.