ObesityPhase 1NCT01055340
A Study That Will Evaluate Ketogenesis and Glucose-Dependent Insulin Secretion Methodologies in Healthy Male Subjects (MK-0000-159)(COMPLETED)
A Phase 1 study testing Oxyntomodulin (OXM) and Comparator: Oxyntomodulin (OXM) in people with Obesity, run by Merck Sharp & Dohme LLC.
Trial summary
This study will test the hypotheses that a single dose of oxyntomodulin (OXM) will be neutral or better than placebo in lowering ambient glucose levels during a graded glucose infusion (GGI) and that a single dose of OXM will lead to a statistically significant increase in the sum of the plasma βOHB + AcAc levels… 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
- Obesity
- What is being tested?
- Oxyntomodulin (OXM) and Comparator: Oxyntomodulin (OXM)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Jun 2010
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is judged to be in good health based on medical history, physical examination, and laboratory safety tests
- Subject has a Body Mass Index of ≥27 kg/m^2 and ≤35 kg/m^2 and weighs ≥70 kg at the prestudy (screening) visit
- Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
- Subject is willing to avoid strenuous physical activity (weight lifting, running, bicycling, etc.) for the duration of the study
Who cannot join
- Subject is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit
- Subject has a history of stroke, chronic seizures, or major neurological disorder
- Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- Subject has irritable bowel disease, or recurrent occurrences of nausea, vomiting, diarrhea, or abdominal pain
- Subject has a history of hypertension requiring treatment
- Subject has a history of cancer
- Subject has history of diabetes, or family history of diabetes mellitus
- Subject has a history of hypersensitivity to OXM or hemaccel
About this study
Official title: A Randomized Clinical Trial to Study Ketogenesis and Glucose-Dependent Insulin Secretion Methodologies in Healthy Male Subjects
This study will test the hypotheses that a single dose of oxyntomodulin (OXM) will be neutral or better than placebo in lowering ambient glucose levels during a graded glucose infusion (GGI) and that a single dose of OXM will lead to a statistically significant increase in the sum of the plasma βOHB + AcAc levels compared to placebo.
- Conditions
- Obesity
- Being tested
- Oxyntomodulin (OXM), Comparator: Oxyntomodulin (OXM), Comparator: Placebo [ hemaccel-containing saline]
- Keywords
- Ketogenesis, Glucose-Dependent Insulin Secretion, Graded Glucose Infusion, Oxyntomodulin
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxyntomodulin (OXM)Drug
Single infusion of OXM 3.0 pmol/kg/min by IV
Comparator: Oxyntomodulin (OXM)Drug
Single infusion of OXM 0.6 pmol/kg/min by IV
Comparator: Placebo [ hemaccel-containing saline]Drug
Single Placebo infusion of hemaccel-containing saline by IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence 1 | Experimental | OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min - Placebo Receives: Drug: Oxyntomodulin (OXM); Drug: Comparator: Oxyntomodulin (OXM); Drug: Comparator: Placebo [ hemaccel-containing saline] |
| Treatment sequence 2 | Experimental | OXM 0.6 pmol/kg/min - Placebo - OXM 3.0 pmol/kg/min Receives: Drug: Oxyntomodulin (OXM); Drug: Comparator: Oxyntomodulin (OXM); Drug: Comparator: Placebo [ hemaccel-containing saline] |
| Treatment sequence 3 | Experimental | Placebo - OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min Receives: Drug: Oxyntomodulin (OXM); Drug: Comparator: Oxyntomodulin (OXM); Drug: Comparator: Placebo [ hemaccel-containing saline] |
| Treatment sequence 4 | Experimental | OXM 3.0 pmol/kg/min - Placebo - OXM 0.6 pmol/kg/min Receives: Drug: Oxyntomodulin (OXM); Drug: Comparator: Oxyntomodulin (OXM); Drug: Comparator: Placebo [ hemaccel-containing saline] |
| Treatment sequence 5 | Experimental | Placebo - OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min Receives: Drug: Oxyntomodulin (OXM); Drug: Comparator: Oxyntomodulin (OXM); Drug: Comparator: Placebo [ hemaccel-containing saline] |
| Treatment sequence 6 | Experimental | OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min - Placebo Receives: Drug: Oxyntomodulin (OXM); Drug: Comparator: Oxyntomodulin (OXM); Drug: Comparator: Placebo [ hemaccel-containing saline] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambient plasma glucose concentration during the GGI
Measured: Last 160 minutes of OXM/placebo infusion
plasma βOHB + AcAc concentrations
Measured: First 300 minutes of OXM/placebo infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055340
- Sponsor's protocol ID
- 0000-159
- Other IDs
- 159, 2010_506
- Status last verified
- May 2015
- First submitted
- 22 Jan 2010
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Shankar SS, Shankar RR, Mixson LA, Miller DL, Pramanik B, O'Dowd AK, Williams DM, Frederick CB, Beals CR, Stoch SA, Steinberg HO, Kelley DE. Native Oxyntomodulin Has Significant Glucoregulatory Effects Independent of Weight Loss in Obese Humans With and Without Type 2 Diabetes. Diabetes. 2018 Jun;67(6):1105-1112. doi: 10.2337/db17-1331. Epub 2018 Mar 15.
PubMed 29545266Shankar SS, Shankar RR, Mixson LA, Miller DL, Chung C, Cilissen C, Beals CR, Stoch SA, Steinberg HO, Kelley DE. Linearity of beta-cell response across the metabolic spectrum and to pharmacology: insights from a graded glucose infusion-based investigation series. Am J Physiol Endocrinol Metab. 2016 Jun 1;310(11):E865-73. doi: 10.1152/ajpendo.00527.2015. Epub 2016 Apr 12.
PubMed 27072496
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Study Ketogenesis and Glucose-Dependent Insulin Secretion Methodologies in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01055340
- Acronym / sponsor ID
- 0000-159
- Conditions
- Obesity
- Keywords
- Ketogenesis, Glucose-Dependent Insulin Secretion, Graded Glucose Infusion, Oxyntomodulin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 25 Jan 2010 (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.
This study will test the hypotheses that a single dose of oxyntomodulin (OXM) will be neutral or better than placebo in lowering ambient glucose levels during a graded glucose infusion (GGI) and that a single dose of OXM will lead to a statistically significant increase in the sum of the plasma βOHB + AcAc levels compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence 1 | Experimental | Drug: Oxyntomodulin (OXM), Drug: Comparator: Oxyntomodulin (OXM), Drug: Comparator: Placebo [ hemaccel-containing saline]OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min - Placebo |
| Treatment sequence 2 | Experimental | Drug: Oxyntomodulin (OXM), Drug: Comparator: Oxyntomodulin (OXM), Drug: Comparator: Placebo [ hemaccel-containing saline]OXM 0.6 pmol/kg/min - Placebo - OXM 3.0 pmol/kg/min |
| Treatment sequence 3 | Experimental | Drug: Oxyntomodulin (OXM), Drug: Comparator: Oxyntomodulin (OXM), Drug: Comparator: Placebo [ hemaccel-containing saline]Placebo - OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min |
| Treatment sequence 4 | Experimental | Drug: Oxyntomodulin (OXM), Drug: Comparator: Oxyntomodulin (OXM), Drug: Comparator: Placebo [ hemaccel-containing saline]OXM 3.0 pmol/kg/min - Placebo - OXM 0.6 pmol/kg/min |
| Treatment sequence 5 | Experimental | Drug: Oxyntomodulin (OXM), Drug: Comparator: Oxyntomodulin (OXM), Drug: Comparator: Placebo [ hemaccel-containing saline]Placebo - OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min |
| Treatment sequence 6 | Experimental | Drug: Oxyntomodulin (OXM), Drug: Comparator: Oxyntomodulin (OXM), Drug: Comparator: Placebo [ hemaccel-containing saline]OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min - Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject is judged to be in good health based on medical history, physical examination, and laboratory safety tests
- Subject has a Body Mass Index of ≥27 kg/m^2 and ≤35 kg/m^2 and weighs ≥70 kg at the prestudy (screening) visit
- Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
- Subject is willing to avoid strenuous physical activity (weight lifting, running, bicycling, etc.) for the duration of the study
Key exclusion criteria (8 listed)
- Subject is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit
- Subject has a history of stroke, chronic seizures, or major neurological disorder
- Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- Subject has irritable bowel disease, or recurrent occurrences of nausea, vomiting, diarrhea, or abdominal pain
- Subject has a history of hypertension requiring treatment
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 |
|---|---|---|
| Oxyntomodulin (OXM)Single infusion of OXM 3.0 pmol/kg/min by IV | Drug | Treatment sequence 1, Treatment sequence 2, Treatment sequence 3, Treatment sequence 4, Treatment sequence 5, Treatment sequence 6 |
| Comparator: Oxyntomodulin (OXM)Single infusion of OXM 0.6 pmol/kg/min by IV | Drug | Treatment sequence 1, Treatment sequence 2, Treatment sequence 3, Treatment sequence 4, Treatment sequence 5, Treatment sequence 6 |
| Comparator: Placebo [ hemaccel-containing saline]Single Placebo infusion of hemaccel-containing saline by IV | Drug | Treatment sequence 1, Treatment sequence 2, Treatment sequence 3, Treatment sequence 4, Treatment sequence 5, Treatment sequence 6 |
Primary outcome
Ambient plasma glucose concentration during the GGI
Time frame: Last 160 minutes of OXM/placebo infusion
plasma βOHB + AcAc concentrations
Time frame: First 300 minutes of OXM/placebo infusion
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 29 May 2015.
- Derived from this study: PubMed 29545266Shankar SS, Shankar RR, Mixson LA, Miller DL, Pramanik B, O'Dowd AK, Williams DM, Frederick CB, Beals CR, Stoch SA, Steinberg HO, Kelley DE. Native Oxyntomodulin Has Significant Glucoregulatory Effects Independent of Weight Loss in Obese Humans With and Without Type 2 Diabetes. Diabetes. 2018 Jun;67(6):1105-1112. doi: 10.2337/db17-1331. Epub 2018 Mar 15.
- Derived from this study: PubMed 27072496Shankar SS, Shankar RR, Mixson LA, Miller DL, Chung C, Cilissen C, Beals CR, Stoch SA, Steinberg HO, Kelley DE. Linearity of beta-cell response across the metabolic spectrum and to pharmacology: insights from a graded glucose infusion-based investigation series. Am J Physiol Endocrinol Metab. 2016 Jun 1;310(11):E865-73. doi: 10.1152/ajpendo.00527.2015. Epub 2016 Apr 12.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxyntomodulin (OXM) and Comparator: Oxyntomodulin (OXM) in people with Obesity, run by Merck Sharp & Dohme LLC.
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 8 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 29 May 2015. 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 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?
Ambient plasma glucose concentration during the GGI (time frame: Last 160 minutes of OXM/placebo infusion). The study lists 2 primary outcomes in all. 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 NCT01055340, which also lists 2 linked publications.
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 May 2015.