ObesityPhase 1NCT02692781
A Single-dose, Dose-escalation Study of a Long-acting MOD-6031 in Healthy Overweight or Obese Subjects
A Phase 1 study testing MOD-6031 in people with Obesity, run by OPKO Health, Inc. at 1 site in Israel.
Trial summary
MOD-6031 is a long-acting reversibly PEGylated oxyntomodulin (OXM) therapeutic. The active moiety is a gastrointestinal neuropeptide with a sequence identical to endogenous human OXM and is an agonist for both glucagon-like peptide-1 (GLP1) and glucagon (GCG) receptors. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- MOD-6031
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2016to 15 Dec 2016
- Phase
- Phase 1
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male, between 18 to 55 years of age.
- BMI 27-35 Kg/m2 (inclusive).
- Generally good health.
- Triglyceride ≤ 400mg/ml
- ECG with no clinically significant abnormalities.
- Negative HIV, hepatitis B or hepatitis C serology tests at screening
- No significant abnormalities in clinical laboratory parameters
- No history of alcohol or drug abuse.
Who cannot join
- History of clinically significant medical condition.
- Any cardiac conduction defect.
- Any acute or unstable disease.
- History of malignancy diagnosed within the past 5 years.
- Known or suspected diabetes and/or HbA1C >6.4% on screening.
- Known allergy to any drug.
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- Treatment with weight loss drugs (within 3 months prior to dosing).
- Liposuction or other surgery for weight loss within the last year.
- Evidence of eating disorders (bulimia, binge eating).
- History of regular alcohol consumption exceeding.
- Use of tobacco or nicotine-containing products.
- Subjects that have difficulty fasting or consuming the standard meals that will be provided.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Single-Blinded, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of MOD-6031 in Healthy Volunteers
MOD-6031 is a long-acting reversibly PEGylated oxyntomodulin (OXM) therapeutic. The active moiety is a gastrointestinal neuropeptide with a sequence identical to endogenous human OXM and is an agonist for both glucagon-like peptide-1 (GLP1) and glucagon (GCG) receptors. The peptide is a natural appetite suppressant, secreted by L-cells in the digestive system following food intake leading to a decrease in gastric emptying, satiety after crossing the blood-brain barrier, and regulation of insulin and glucose levels. Thus, MOD-6031 is being developed as a treatment for high risk subjects (obese) to increase weight loss, reduce food intake and increase glycemic control.
Read the detailed description
This will be a a randomized, single-blind, placebo-controlled, single-dose, dose-escalation study. Five escalating dose groups are planned, with 8 subjects per dose group, randomized in 3:1 ratio to receive a single dose of MOD-6031 or matching Placebo (6 MOD-6031 to 2 placebo subjects). The initial MOD-6031 dose will be 20 mg, followed by single doses of 50 mg, 100 mg, 150 mg and 200 mg. Each subject will receive a single study drug injection in the morning (dosing day designated as Day 0) and will be monitored for 30 days.
- Conditions
- Obesity
- Being tested
- MOD-6031, Placebo control
- Keywords
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOD-6031Drug
Placebo controlOther
| Study group | Role | What they receive |
|---|---|---|
| Dose Cohort 1 | Experimental | 20mg MOD-6031 / Placebo Receives: Drug: MOD-6031; Other: Placebo control |
| Dose Cohort 2 | Experimental | 50mg MOD-6031 / Placebo Receives: Drug: MOD-6031; Other: Placebo control |
| Dose Cohort 3 | Experimental | 100mg MOD-6031 / Placebo Receives: Drug: MOD-6031; Other: Placebo control |
| Dose Cohort 4 | Experimental | 150mg MOD-6031 / Placebo Receives: Drug: MOD-6031; Other: Placebo control |
| Dose Cohort 5 | Experimental | 200mg MOD-6031 / Placebo Receives: Drug: MOD-6031; Other: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite safety and tolerability parameters as measured by adverse events, electrocardiograms (ECG), laboratory results, vital signs and injection site reactions
Measured: 30 days
Secondary outcomes (8)
Cmax of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)
Measured: 0 to 30 days
Tmax of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)
Measured: 0 to 30 days
AUC(0-t) of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)
Measured: 0 to 30 days
AUC(inf) of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)
Measured: 0 to 30 days
Elimination rate constant of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)
Measured: 0 to 30 days
T(½) of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)
Measured: 0 to 30 days
CL/F of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)
Measured: 0 to 30 days
Vz/F of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)
Measured: 0 to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion15 Dec 2016
- Study completion15 Dec 2016
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- OPKO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tel-Aviv Sourasky Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692781
- Sponsor's protocol ID
- CP-6-001
- Status last verified
- Sep 2019
- First submitted
- 4 Feb 2016
- Last updated
- 30 Sep 2019
- Results posted
- 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 I, Randomized, Single-Blinded, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of MOD-6031 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02692781
- Acronym / sponsor ID
- CP-6-001
- Conditions
- Obesity
- Keywords
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Tel-Aviv Sourasky Medical Center
- Study start
- Feb 2016
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 26 Feb 2016 (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.
MOD-6031 is a long-acting reversibly PEGylated oxyntomodulin (OXM) therapeutic. The active moiety is a gastrointestinal neuropeptide with a sequence identical to endogenous human OXM and is an agonist for both glucagon-like peptide-1 (GLP1) and glucagon (GCG) receptors. The peptide is a natural appetite suppressant, secreted by L-cells in the digestive system following food intake leading to a decrease in gastric emptying, satiety after crossing the blood-brain barrier, and regulation of insulin and glucose levels. Thus, MOD-6031 is being developed as a treatment for high risk subjects (obese) to increase weight loss, reduce food intake and increase glycemic control.
Detailed description
This will be a a randomized, single-blind, placebo-controlled, single-dose, dose-escalation study. Five escalating dose groups are planned, with 8 subjects per dose group, randomized in 3:1 ratio to receive a single dose of MOD-6031 or matching Placebo (6 MOD-6031 to 2 placebo subjects). The initial MOD-6031 dose will be 20 mg, followed by single doses of 50 mg, 100 mg, 150 mg and 200 mg. Each subject will receive a single study drug injection in the morning (dosing day designated as Day 0) and will be monitored for 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose Cohort 1 | Experimental | Drug: MOD-6031, Other: Placebo control20mg MOD-6031 / Placebo |
| Dose Cohort 2 | Experimental | Drug: MOD-6031, Other: Placebo control50mg MOD-6031 / Placebo |
| Dose Cohort 3 | Experimental | Drug: MOD-6031, Other: Placebo control100mg MOD-6031 / Placebo |
| Dose Cohort 4 | Experimental | Drug: MOD-6031, Other: Placebo control150mg MOD-6031 / Placebo |
| Dose Cohort 5 | Experimental | Drug: MOD-6031, Other: Placebo control200mg MOD-6031 / Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male, between 18 to 55 years of age.
- BMI 27-35 Kg/m2 (inclusive).
- Generally good health.
- Triglyceride ≤ 400mg/ml
- ECG with no clinically significant abnormalities.
Key exclusion criteria (12 listed)
- History of clinically significant medical condition.
- Any cardiac conduction defect.
- Any acute or unstable disease.
- History of malignancy diagnosed within the past 5 years.
- Known or suspected diabetes and/or HbA1C >6.4% on screening.
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 |
|---|---|---|
| MOD-6031 | Drug | Dose Cohort 1, Dose Cohort 2, Dose Cohort 3, Dose Cohort 4, Dose Cohort 5 |
| Placebo control | Other | Dose Cohort 1, Dose Cohort 2, Dose Cohort 3, Dose Cohort 4, Dose Cohort 5 |
Primary outcome
Composite safety and tolerability parameters as measured by adverse events, electrocardiograms (ECG), laboratory results, vital signs and injection site reactions
Time frame: 30 days
8 secondary outcomes
Cmax of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)
Time frame: 0 to 30 days
Tmax of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)
Time frame: 0 to 30 days
AUC(0-t) of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)
Time frame: 0 to 30 days
AUC(inf) of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)
Time frame: 0 to 30 days
Elimination rate constant of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)
Time frame: 0 to 30 days
T(½) of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)
Time frame: 0 to 30 days
CL/F of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)
Time frame: 0 to 30 days
Vz/F of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)
Time frame: 0 to 30 days
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MOD-6031 in people with Obesity, run by OPKO Health, Inc. at 1 site in Israel.
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 8 inclusion and 12 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 1 site in Israel. 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.
What does this 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.
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?
Composite safety and tolerability parameters as measured by adverse events, electrocardiograms (ECG), laboratory results, vital signs and injection site reactions (time frame: 30 days). 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.