Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sc
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis (TAG-MS): A Phase 2, Randomized, Double-Blind, Parallel-Arm Study
What it found
No result yet.
What was tested
Treatment tested
- Pegsebrenatide
Glucagon-like peptide 1 receptor agonist
Placebo
- Placebo
What it measured
Main measures
Change in normalized (for head size) brain parenchymal volume (nBPV)
Baseline, week 48, and week 96
Other measures (21)
Change in normalized gray matter volume (mL)
Baseline, week 48, and week 96
Brain volume lossChange in thalamic volume (mL)
Baseline, week 48, and week 96
Brain volume lossChange in cortical thickness (mm)
Baseline, week 48, and week 96
Change in retinal nerve fiber layer thickness
Baseline, week 48, and week 96
Retina scans (OCT)Change in ganglion cell/inner plexiform thickness
Baseline, week 48, and week 96
Retina scans (OCT)Disability progression as assessed by the Expanded Disability Status Scale (EDSS)
Approximately every 24 weeks, up to 96 weeks
Disability progressionDisability progression as assessed by the Multiple Sclerosis Functional Composite (MSFC)
Approximately every 24 weeks, up to 96 weeks
Disability progressionThinking and memoryArm and hand functionDisability progression as assessed by the Expanded Disability Status Scale-Plus
Approximately every 24 weeks, up to 96 weeks
Disability progressionWalking and mobilityPatient-reported disability progression as assessed by the Patient-Determined Disease Steps
Approximately every 24 weeks, up to 96 weeks
Disability progressionQuality of life (reported by participants)Change in self-reported anxiety as assessed by the Quality of Life in Neurological Disorders (Neuro-QOL) Anxiety Subscale
Approximately every 24 weeks, up to 96 weeks
Mood and sleepQuality of life (reported by participants)
Who could take part
MS (type not specified) · 18 to 60
Show the full 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 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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).
Papers
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History
Started
Apr 2026
Main results due
Jan 2030
Finished
Jan 2030