A Phase 3 interventional study of Phentermine-Topiramate and Liraglutide in Obesity, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-07-18.
Sponsored by Mayo Clinic · Phase 3, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 106 studies in Obesity by Mayo Clinic — 17 open to participants now, 24 under way, none of them phase 3. Obesity · Mayo Clinic.
Among the 106 studies in Obesity by Mayo Clinic, this one is the 7th largest by enrollment of the 97 interventional ones that give a count, is one of 7 that started in 2017, is one of 5 in phase 3, and was the 63rd registered.
11,536 studies on the registry are indexed under Obesity; 2,042 are open to participants now.
Browse Obesity studies →17 of the 106 studies in Obesity by Mayo Clinic are open now, in 1 country. Recruiting first, the newest first:
Mayo Clinic · Sites in United States
Ages 18–55 · Healthy volunteers
Mayo Clinic · Sites in United States
Ages 46–60 · Women only · Healthy volunteers
Mayo Clinic · Sites in United States
Ages 18–65
Mayo Clinic · Sites in United States
Ages 18–64 · Healthy volunteers
Mayo Clinic · Sites in United States
Ages 55–85
By country, each count listing its studies:
Of the 1,339 Obesity studies recruiting now, 377 (28%) set no upper age limit and 859 (64%) stop at 75 or younger; 167 take children under 18; 490 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
106 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 16 · Phase 2 10 · Phase 3 8 · Phase 4 16
First in 2003; this study’s year is marked. 7 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 193 is above the median of 67 across 9,016 interventional studies indexed under Obesity.
Median enrollment 32 across the 97 interventional studies, 49 across the 8 observational. Of the 79 that completed or were terminated, 30 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
Mayo Clinic is the lead sponsor of 3,271 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
9 of the studies in Obesity by Mayo Clinic that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03866408Mayo ClinicInsulin Regulation of Lipolysis and Lipolysis Proteins | 2026-12-30 |
| NCT07057310Mayo ClinicAging Well: Targeting Obesity With GLP-1 Agonists to Enhance Physical and Vascular Health in Postmenopausal Women | 2026-12-31 |
| NCT04297592Mayo ClinicAntibiotic Prophylaxis in High-Risk Arthroplasty Patients | 2027-01 |
| NCT03238794Mayo ClinicBariatric Surgery Versus Diet Alone in the Bile Acid Pathway and Weight Loss | 2027-01-11 |
| NCT06782529Mayo ClinicKnee Injections for Obese Patients With Knee Arthritis | 2027-01-24 |
Add all 9 to your calendar (.ics) → With an account.
Among the 106 studies in Obesity by Mayo Clinic, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The researchers are trying to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss.
All participants will be phenotype and participants will randomized to randomly assigned medications vs phenotype guided medications for obesity. All participants will receive a standard intense lifestyle intervention.All participants will be seen at 4 and 12 weeks. At the 12-week visit, participants will be unblinded to their "obesity-related phenotype" and they could contact their physician to continue a FDA-approved medication as part of clinical care. Study team will prospectively follow the patients' weight, waist circumference and use of obesity medications every 3 months for 1 year.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise
Drug: Phentermine-Topiramate · Drug: Liraglutide · Drug: Naltrexone/bupropion
Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine
Drug: Phentermine-Topiramate · Drug: Liraglutide · Drug: Naltrexone/bupropion · Drug: Phentermine
Drug pages: Phentermine · Topiramate
Extended Release at dose of 7.5/46 mg oral daily
Also known as: Qsymia
dose of 3 mg subcutaneous daily
Also known as: Saxenda
Drug pages: Naltrexone · Bupropion
Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)
Also known as: Contrave
15-37.5 mg oral daily
Also known as: Adipex-P, Lomaira
Change in Total Body Weight
Percent change in body weight
Time frame: baseline to 12 weeks
Percentage of Responders
Percentage of participants who loss 5% or more of total body weight
Time frame: baseline to 12 weeks
Percentage of Responders
Percentage of participants with at least 10% total body weight loss
Time frame: baseline to 12 weeks
| Milestone | Intervention Group | Control Group |
|---|---|---|
| Started | 93 | 100 |
| Completed | 93 | 100 |
| Not completed | 0 | 0 |
Percent change in body weight
| percent change | Intervention Group | Control Group |
|---|---|---|
| Change in Total Body Weight | -7.7 (-11 to -4.7) | -6.5 (-11 to -2.3) |
Percentage of participants who loss 5% or more of total body weight
| percentage of participants | Intervention Group | Control Group |
|---|---|---|
| Percentage of Responders | 81 | 80 |
Percentage of participants with at least 10% total body weight loss
| percentage of participants | Intervention Group | Control Group |
|---|---|---|
| Percentage of Responders | 44 | 40 |
Collected over Baseline to 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group | 0/93 (0%) | 0/93 (0%) | 23/93 (24.7%) |
| Control Group | 0/100 (0%) | 0/100 (0%) | 25/100 (25%) |
| Event | Intervention Group | Control Group |
|---|---|---|
| During studyGastrointestinal disorders | 23/93 | 25/100 |
| Age, Categorical(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 93 | 100 | 193 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Mean | 38.5 ± 16 | 39 ± 14 | 39 ± 15 |
| Sex: Female, Male(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Female | 65 | 78 | 143 |
| Male | 28 | 22 | 50 |
| Race (NIH/OMB)(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 2 | 2 |
| White | 88 | 87 | 175 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 10 | 13 |
| Region of Enrollment(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| United States | 93 | 100 | 193 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2017 to primary completion in May 2022, 53 months.
Results were first posted in Jul 2023, 1 year 1 month after primary completion.
Of 63 non-industry phase 3 interventional studies under Obesity, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 56. This study's 53 months is above that.
Counting every sponsor, half of 262 studies reached it within 24 months; a quarter within 18 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.