Glucagon-like Peptide-1 Receptor Agonists for Multiple Sclerosis
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Recruiting
Phase 2Interventional Study
Multiple Sclerosis
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 60
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
Johns Hopkins University · Other
Who this trial is looking for
This trial is looking for adults with Multiple Sclerosis who are stable on treatment. Participants will take either the study drug or a placebo to help see if it can reduce brain and eye damage.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with Multiple Sclerosis
I am between 18 and 60 years old
I have a body mass index of 27 or higher
I have been stable on MS therapy for at least 12 months
You may not be able to join if
I have a history of pancreatitis or gastroparesis
I have a personal or family history of medullary thyroid carcinoma
I have chronic kidney disease or type 1 diabetes
I am pregnant or breastfeeding, or plan to become pregnant
I have experienced substance abuse recently
I have known allergies to GLP-1 receptor agonists
My neurologist or the study team has concerns about my participation
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The goal of this clinical trial is to evaluate if the study drug will reduce brain and retinal atrophy by reducing inflammation and subsequently slowing neurodegeneration in people with Multiple Sclerosis. The main outcome for the trial is change in normalized brain parenchymal volume (nBPV), measured by magnetic resonance imaging (MRI).
Researchers will compare outcomes from participants randomi…
The goal of this clinical trial is to evaluate if the study drug will reduce brain and retinal atrophy by reducing inflammation and subsequently slowing neurodegeneration in people with Multiple Sclerosis. The main outcome for the trial is change in normalized brain parenchymal volume (nBPV), measured by magnetic resonance imaging (MRI).
Researchers will compare outcomes from participants randomized to the study drug, versus participants randomized to placebo, to see if there are signs of slowed neurodegeneration (i.e., reduction in brain and retinal atrophy).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Diagnosis of MS (2024 criteria); clinically stable on MS therapy for ≥12 months without relapse or new lesions on brain MRI
* Aged 18-60 years
* Body mass index ≥27.0 kg/m2
Exclusion Criteria:
* No GLP-1RA or GIP/GLP-1 RA in past year; no known hypersensitivity to medication…
Inclusion Criteria:
* Diagnosis of MS (2024 criteria); clinically stable on MS therapy for ≥12 months without relapse or new lesions on brain MRI
* Aged 18-60 years
* Body mass index ≥27.0 kg/m2
Exclusion Criteria:
* No GLP-1RA or GIP/GLP-1 RA in past year; no known hypersensitivity to medication class
* No known Barrett's esophagus/gastroesophageal reflux disease, pancreatitis (including past), or gastroparesis
* No personal/family history of medullary thyroid carcinoma or history of multiple endocrine neoplasia syndrome type 2
* No chronic kidney disease (estimated glomerular filtration rate ≤50 mL/min) in past year, type 1 diabetes, known diabetic retinopathy, use of insulin or insulin-inducing medications\*, dipeptidyl peptidase IV inhibitors\*\*, or warfarin; current/active alcohol or illicit substance abuse
* No concerns about candidacy of individual on part of person's neurologist or study team clinicians
* Current or planned (next 2 years) pregnancy/breastfeeding; if able to become pregnant, agree to reliable contraception (contraception requirements as discussed below)\*\*\*
* currently-approved: Lispro, Aspart, Glulisine, Afrezza, Regular, Concentrated Regular, or Novolin, Velosulin, NPH, glargine, detemir, degludec, and premixed; approved secretagogues: sulphonylureas (e.g. glipizide (± metformin), glyburide (± metformin), glimepiride, pioglitazone/glimepiride) \& meglitinide analogues (nateglinide and repaglinide); \*\* currently-approved:sitagliptin, saxagliptin, linagliptin, alogliptin \*\*\*Contraception: Participants of childbearing potential (participant has a uterus and is pre-menopausal) must agree to use contraception, using either one method with a failure rate of \<1%/year, or two methods of lesser effectiveness:
Contraceptive methods with a failure rate of \< 1% per year includes the following:
* Combined (estrogen and progesterone containing) hormonal contraception (vaginal ring, birth control patch) or progesterone-only hormonal contraception (birth control injections, intrauterine device (IUD), or hormone-releasing implant), or copper IUD
* Complete abstinence from sexual encounters with a person who has testes
Those who do not wish to use one of the above methods of contraception must use two methods. Options include:
* Oral hormonal contraception plus one barrier method during sexual encounter with a person who has testes (below). While typically oral hormonal contraception has a low failure rate, it is possible that the absorption of contraceptive pills taken by mouth will be impacted by the study drug and thus lower contraceptive effectiveness. Thus, people using pills as primary contraception must, during asexual encounter with a person who has testes, use a second form of barrier contraceptive (below) or must change to one of the other contraceptive methods listed above.
* Two forms of barrier contraception during sexual encounter with a person who has testes. Examples of barrier contraceptive methods include the following:
* A condom with or without spermicide
* A cap, diaphragm, or sponge with or without spermicide
* Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
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