ObesityPhase 2NCT03523273
Pilot Study of the Effect of Liraglutide 3.0 mg on Weight Loss and Gastric Functions in Obesity
A Phase 2 study testing Liraglutide in people with Obesity, run by Michael Camilleri, MD at 1 site in United States.
Trial summary
This study is being done to assess the stomach emptying effect of a maximum dose of 3 mg Liraglutide compared to placebo in subjects who are overweight or obese. Liraglutide is a medication approved by the Food and Drug Administration (FDA) for routine clinical use. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Liraglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2017to 31 Aug 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight and obese adults (≥30 kg/m^2 or ≥27 kg/m^2 with an obesity-related co-morbidity).
- Subjects residing within 125 miles of Mayo Clinic in Rochester, Minnesota.
- Healthy individuals with no unstable psychiatric disease and not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, or endocrine (other than hyperglycemia type 2 diabetes mellitus on metformin) disorders.
- The investigators plan to recruit equal proportions of men and women.
- Women of childbearing potential will be using an effective form of contraception, and have negative pregnancy tests within 48 hours of enrollment and before each radiation exposure. In addition, since liraglutide 3.0 mg is classified as Pregnancy Category X, monthly urine pregnancy testing will be performed in any female participant with childbearing potential.
- Subjects must have the ability to provide informed consent before any trial-related activities.
Who cannot join
- Weight exceeding 137 kilograms (safety limit of camera for measuring gastric volumes).
- Abdominal surgery other than appendectomy, cholecystectomy, Caesarian section or tubal ligation.
- Positive history of chronic gastrointestinal diseases, systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption, e.g., orlistat.
- Patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia-type 2.
- Patients with a past or current history of pancreatitis, gallstones, history of alcoholism, blood triglyceride levels >500 mg/dL.
- Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), a self-administered alcoholism screening test (AUDIT-C), and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by a HAD score >11 on either the Anxiety or Depression subscales, or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.
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- Intake of any medication (except multivitamins), within 7 days of the study. Exceptions are birth control pill, estrogen replacement therapy, thyroxin replacement therapy and any medication administered for co-morbidities as long as they do not alter gastrointestinal motility including gastric emptying (GE) and gastric accommodation. For example, statins for hyperlipidemia, diuretics, β-adrenergic blockers, Angiotensin Converting Enzyme (ACE) inhibitors and angiotensin antagonists for hypertension, and metformin for type 2 diabetes mellitus or prediabetes are permissible. In contrast, resin sequestrants for hyperlipidemia (which may reduce GE and reduce appetite, α2-adrenergic agonists for hypertension, or other glucagon-like peptide-1 receptor agonists (GLP-1) receptor agonists (exenatide) or amylin analogs (pramlintide) are not permissible because they significantly affect GE and/or gastric accommodation.
- Delayed gastric emptying at 2 and 4 hours
- Hypersensitivity to the study medication, liraglutide
- Participate in highly intense physical activity program that could potentially interfere with study interpretation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
This study is being done to assess the stomach emptying effect of a maximum dose of 3 mg Liraglutide compared to placebo in subjects who are overweight or obese. Liraglutide is a medication approved by the Food and Drug Administration (FDA) for routine clinical use.
- Conditions
- Obesity
- Being tested
- Liraglutide, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Saxenda, Victoza
Initiate at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6mg/day in weekly intervals to a dose of 3.0 mg/day is achieved (~4 weeks). Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
PlaceboDrug
Placebo administration will match the study drug.
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Experimental | Liraglutide initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication. Receives: Drug: Liraglutide |
| Placebo | Experimental | Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric Emptying of Solids (T1/2)
The time for half of the ingested solids to leave the stomach. Following a meal consisting of two eggs labeled with technetium Tc 99m sulfur colloid (1 mCi), gastric emptying of solids was assessed with scintigraphy imaging.
Measured: 5 weeks
Gastric Emptying of Solids (T1/2)
The time for half of the ingested solids to leave the stomach. Following a meal consisting of two eggs labeled with technetium Tc 99m sulfur colloid (1 mCi), gastric emptying of solids was assessed with scintigraphy imaging.
Measured: 16 weeks
Secondary outcomes (8)
Change in Weight at 5 Weeks
Change in subject's weight, in kilograms
Measured: baseline, 5 weeks
Change in Weight at 16 Weeks
Change in subject's weight, in kilograms
Measured: baseline, 16 weeks
Satiety
Subjects self-reported fullness after eating as much of a prescribed meal measured by kilocalories of food consumed.
Measured: 16 weeks
Satiation Volume to Fullness
Subjects ingest Ensure 300mL drink meal at a constant rate of 30mL/min until self-reported fullness and volume consumed will be measured in milliliters (mL).
Measured: 16 weeks
Maximum Satiation
Subjects ingest Ensure 300mL drink meal at a constant rate of 30mL/min until they reach maximum or unbearable fullness. Volume consumed will be measured in milliliters (mL).
Measured: 16 weeks
Fasting Gastric Volume Prior to Meal
Gastric fasting volume was measured prior to a meal of 300 mL Ensure drink using noninvasive single photon emission-computed tomography (SPECT) of the stomach.
Measured: 16 weeks
Gastric Volume After Meal
Gastric volume was measured after a meal of 300 mL Ensure drink using noninvasive single photon emission-computed tomography (SPECT) of the stomach.
Measured: 16 weeks
Gastric Accommodation
Measured in milliliters (mL), using the difference between the fasting gastric volume prior to the meal and the gastric volume after the meal.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start29 Nov 2017
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Camilleri, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Novo Nordisk A/S
- Responsible party
- Sponsor-investigator, Michael Camilleri, MD, Mayo Clinic
- Investigators
- Michael Camilleri, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523273
- Sponsor's protocol ID
- 15-001783 Part B
- Other IDs
- R56DK067071, UL1TR000135
- Status last verified
- May 2022
- First submitted
- 1 May 2018
- Last updated
- 23 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Effect of Liraglutide 3.0 mg on Weight Loss and Gastric Functions in Obesity
- ClinicalTrials.gov ID
- NCT03523273
- Acronym / sponsor ID
- 15-001783 Part B
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Michael Camilleri, MDUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Novo Nordisk A/S
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Posted 23 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to assess the stomach emptying effect of a maximum dose of 3 mg Liraglutide compared to placebo in subjects who are overweight or obese. Liraglutide is a medication approved by the Food and Drug Administration (FDA) for routine clinical use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Experimental | Drug: LiraglutideLiraglutide initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication. |
| Placebo | Experimental | Drug: PlaceboPlacebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Overweight and obese adults (≥30 kg/m^2 or ≥27 kg/m^2 with an obesity-related co-morbidity).
- Subjects residing within 125 miles of Mayo Clinic in Rochester, Minnesota.
- Healthy individuals with no unstable psychiatric disease and not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, or endocrine (other than hyperglycemia type 2 diabetes mellitus on metformin) disorders.
- The investigators plan to recruit equal proportions of men and women.
- Women of childbearing potential will be using an effective form of contraception, and have negative pregnancy tests within 48 hours of enrollment and before each radiation exposure. In addition, since liraglutide 3.0 mg is classified as Pregnancy Category X, monthly urine pregnancy testing will be performed in any female participant with childbearing potential.
Key exclusion criteria (10 listed)
- Weight exceeding 137 kilograms (safety limit of camera for measuring gastric volumes).
- Abdominal surgery other than appendectomy, cholecystectomy, Caesarian section or tubal ligation.
- Positive history of chronic gastrointestinal diseases, systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption, e.g., orlistat.
- Patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia-type 2.
- Patients with a past or current history of pancreatitis, gallstones, history of alcoholism, blood triglyceride levels >500 mg/dL.
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 |
|---|---|---|
| LiraglutideAlso: Saxenda, VictozaInitiate at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6mg/day in weekly intervals to a dose of 3.0 mg/day is achieved (~4 weeks). Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication. | Drug | Liraglutide |
| PlaceboPlacebo administration will match the study drug. | Drug | Placebo |
Primary outcome
Gastric Emptying of Solids (T1/2)
Time frame: 5 weeks
The time for half of the ingested solids to leave the stomach. Following a meal consisting of two eggs labeled with technetium Tc 99m sulfur colloid (1 mCi), gastric emptying of solids was assessed with scintigraphy imaging.
Gastric Emptying of Solids (T1/2)
Time frame: 16 weeks
The time for half of the ingested solids to leave the stomach. Following a meal consisting of two eggs labeled with technetium Tc 99m sulfur colloid (1 mCi), gastric emptying of solids was assessed with scintigraphy imaging.
8 secondary outcomes
Change in Weight at 5 Weeks
Time frame: baseline, 5 weeks
Change in Weight at 16 Weeks
Time frame: baseline, 16 weeks
Satiety
Time frame: 16 weeks
Satiation Volume to Fullness
Time frame: 16 weeks
Maximum Satiation
Time frame: 16 weeks
Fasting Gastric Volume Prior to Meal
Time frame: 16 weeks
Gastric Volume After Meal
Time frame: 16 weeks
Gastric Accommodation
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink 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.
Michael Camilleri, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liraglutide in people with Obesity, run by Michael Camilleri, MD at 1 site in United States.
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 6 inclusion and 10 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 23 Jun 2022. 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 United States. 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 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?
Yes. Results are posted in the registry (first posted 23 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Gastric Emptying of Solids (T1/2) (time frame: 5 weeks). 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?
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 23 Jun 2022.