Effects of Semaglutide Treatment on Psoriatic Lesions in Obese Patients with Type 2 Diabetes Mellitus: An Open-Label, Randomized Clinical Trial
- Design
- Randomized trial · 15 participants · Biomarker outcome
- Match to healthy normal-weight adults aged 55–75
- Different population[Auto] Participants had type 2 diabetes and obesity/overweight (age/BMI not reported in abstract).
- Could weight loss explain it?
- Possibly[Auto] Participants had obesity and/or type 2 diabetes and the abstract does not separate direct drug effects from weight loss or glycaemic improvement.
- Study tier
- Study tier 3[Auto] Small or short randomized trial (auto-provisional).
- Assessment
- Version 1 · automatic, not yet reviewed by a person · Sep 13, 2026
Study facts come from the paper. Population match, weight-loss explanation and study tier are our judgments, made against the reference group of healthy normal-weight adults aged 55–75.
[Auto, unreviewed; last sentences of abstract] A significant decrease in the body mass index (BMI) value in the semaglutide-treated group was also identified, as well as a significant decrease in the level of low-density cholesterol (LDL) (p < 0.05). In conclusion, semaglutide, based on its systemic anti-inflammatory characteristics, could contribute to the treatment of psoriatic obese patients with T2DM.
01Findings
What the study reported
- Drugs
- Semaglutide
- Primary outcome
- Not extracted
- Effect
- Not extracted
- 95% confidence interval
- Not extracted
- Follow-up
- 12 weeks
- Adverse events
- Not extracted
- Limitations
- Auto-classified from abstract only; effect estimates, adverse events and limitations not extracted. Requires manual review.
Who was studied
- Obesity status
- obesity/overweight present (all or most)
- Diabetes status
- type 2 diabetes present (all or most)
- Sample size
- 15
Study quality details
- Study design
- Randomized controlled trial
- Sample size
- 15
- Randomization
- yes
- Blinding
- open-label
- Comparator
- not stated
- Follow up duration
- 12 weeks
- Outcome type
- biomarker
- Replication
- not assessed (auto)
- Consistency with other evidence
- not assessed (auto)
- Population applicability
- INDIRECT
- Statistical precision
- not extracted
- Funding conflicts
- unclear
- Peer review status
- yes
01bRisk of bias
How much the result can be relied on
Risk of bias is judged per result, not per paper: the same study can report one marker at low risk and another at high. Two reviewers assess each result independently against a written guide, and every domain judgment below carries its reasoning and the sentences it rests on.
These words are not quality scores. On the RoB 2 scale, High risk of bias is the worst rating a result can receive and Low risk of bias is the best — the opposite of how the same words read on some other scales. Levels are always written out in full here for that reason.
CRP (mg/L), serum · 12 weeks (F1) vs baseline (F0)
High risk of bias · RoB 2 · Two reviewers agreed on every domain
How the overall was reached: D1 and D5 are High and D2/D3 are Some concerns, so the overall judgment is High on the algorithm without override. Independently of the domain arithmetic, the assessed result is a within-arm pre-post change in a non-concealed, open-label, 13-participant arm with no between-arm contrast of change; it cannot support an assignment effect on CRP at all, and the overall judgment should be read as "high risk of bias for a result that is in any case not an effect estimate".
| Domain | Judgment and reasoning |
|---|---|
| D1 · Randomisation process High risk of bias | No sequence generation method, no allocation concealment method, and no baseline-balance-based reassurance. v1.2 item 6 does not apply: this is not a secondary analysis of an identified parent trial but the primary report of its own study, and NCT06475586 is its own registration, so nothing is inherited. The paper's own design statement is a cohort study, and the control arm is described as not assigned at all, so the answers to 1.1 and 1.2 are N/NI rather than merely undescribed. Baseline imbalance is present and statistically flagged for IL-23, and control CRP is reported on a different summary scale (mean +/- SD) at roughly twice the treated arm's median, so the rebuttable presumption of adequate allocation is in any case contradicted. High, not Some concerns, because the evidence is affirmative that no concealed randomized allocation is described, not merely silent.This was an open labeled interventional cohort study with two groups of participants. A total of 31 patients of both sexes, 18-70 years of age, were divided into two groups |
| D2 · Deviations from intended interventions Some concerns about risk of bias | Wholly open-label, and both participants and investigators were aware of assignment (stated explicitly in Limitations). Under the collection rule, awareness alone rarely biases a serum biomarker, so D2 turns on discontinuation imbalance and ITT handling. Three of 31 participants were excluded post-allocation and the analysed sets are 13 (semaglutide) and 15 (control) per Table 1, i.e. two exclusions from the treated arm (both for semaglutide side effects: nausea, vomiting) and one from the control arm. Exclusion of drug-intolerant participants is exactly the exclusion that an assignment (ITT) effect must retain; no ITT analysis is described anywhere, and the statistical section names only paired and rank tests on completers. The absolute number is small (3/31), so the potential impact is limited rather than substantial: Some concerns rather than High. Note also that co-interventions were not controlled to a protocol beyond metformin and topical salicylic acid, though both arms had the same metformin regimen.Open-label design: Both the patients and the researchers were aware of the treatments being administered, therefore introducing potential for bias During the observed period, three patients were excluded from the study; two of them due to drug side effects (nausea, vomiting), and one patient due to exacerbation of the disease. |
| D3 · Missing outcome data Some concerns about risk of bias | Outcome data are available for 28/31 (90.3%) allocated participants, so the 20% prong does not trip. The per-arm prong does trip: 2/15 (13.3%) missing in the semaglutide arm versus 1/16 (6.3%) in the control arm, a 7.0-point difference, above the 5-point threshold, so "data available for nearly all" is answered PN. The reason for the treated-arm losses is GI intolerance (nausea, vomiting), which correlates with drug exposure and plausibly with the biomarker response, and no sensitivity or MNAR analysis is offered, so "could missingness depend on the true value" is PY. Under the RoB 2 algorithm that pairing points to High; I apply a written override to Some concerns under calibration ruling 2, which reserves High for the case where BOTH prongs trip: here only one prong trips and the absolute attrition is three participants, so the scope for a value-dependent shift in a within-arm median is real but bounded. A reviewer who declines the override lands on High, and this is flagged as the most likely disagreement.During the observed period, three patients were excluded from the study; two of them due to drug side effects (nausea, vomiting), and one patient due to exacerbation of the disease. No 12 (92.3) 15 (100) |
| D4 · Measurement of the outcome Low risk of bias | CRP is an objective serum assay measured at a single institutional laboratory, identically timed in both arms (fasting, 12-14 h after last meal, baseline and end of study). No indication the assay changed partway through or differed between arms; outcome assessors' awareness of assignment cannot plausibly influence an automated chemistry result. Per the collection rule for central-lab CRP, Low.Patients blood samples for biochemical analyses were collected 12-14 h after the last meal, two times during the study, at the beginning and at the end of the study. The concentrations of fasting glucose, fasting insulin, HgbA1C, CRP, homocysteine, total cholesterol, triglycerides, LDL and HDL cholesterol were assessed. These analyses were done at the Institute for Laboratory Diagnostics of the UCC. |
| D5 · Selection of the reported result High risk of bias | No protocol or SAP was retrieved and the registration (NCT06475586) is cited with a 1 July 2024 access date for a study whose ethics approval is dated 14 February 2023, so prespecification of this result is unverifiable at best and the registration appears to postdate conduct. Beyond unverifiability, there is affirmative selection within the retrieved report: both arms were measured for CRP at both timepoints (Table 3 contains all four cells), so the between-arm comparison of CHANGE was available to be computed, yet the paper reports only the two within-arm pre-post tests and then reports a between-arm CRP comparison at BASELINE only (p = 0.07, Table 4) - the one between-arm CRP analysis presented is the one that does not test the effect. The arms are also summarised on different scales for the same parameter in the same row (median (IQR) for semaglutide, mean +/- SD for control), which forecloses a reader's own contrast. Selection of the reported result from among multiple eligible analyses of these data is the better explanation than chance; the domain rule's "at least Some concerns" is a floor and is exceeded here.This trial has been registered at http://www.clinicaltrials.gov/ as NTC06475586 (accessed on 1 July 2024) . Decision number: 01-19-40-2/22, approval date 14 February 2023 |
IL-6 (pg/mL), serum · 12 weeks (F1) vs baseline (F0)
High risk of bias · RoB 2 · Two reviewers agreed on every domain
How the overall was reached: Two High domains (D1, D5) and two Some concerns (D2, D3) give High on the algorithm. As with O1, the assessed result is a within-arm pre-post change, not a between-arm effect, and the control arm's unreported larger median IL-6 fall means the within-arm result would not survive translation into a between-arm contrast in the direction the paper claims.
| Domain | Judgment and reasoning |
|---|---|
| D1 · Randomisation process High risk of bias | Same trial-level judgment as O1: no sequence generation or concealment described, the paper's own methods call the design an open-label interventional cohort study, the control arm is described as not assigned, and baseline imbalance is present (IL-23 p = 0.04). Trial-level, so identical across outcomes.This was an open labeled interventional cohort study with two groups of participants. This group consisted of T2DM patients with psoriasis, who were already on metformin therapy in the maximally tolerated dose but were not assigned to receive any of GLP-1 receptor agonists. |
| D2 · Deviations from intended interventions Some concerns about risk of bias | As O1: open-label with acknowledged awareness on both sides, no ITT analysis, and three post-allocation exclusions (two of them for semaglutide GI intolerance) removed from the analysed sets. Awareness itself is not a material threat to a serum ELISA result, so the judgment rests on the non-ITT completer analysis, whose potential impact is limited at 3/31.Open-label design: Both the patients and the researchers were aware of the treatments being administered, therefore introducing potential for bias During the observed period, three patients were excluded from the study; two of them due to drug side effects (nausea, vomiting), and one patient due to exacerbation of the disease. |
| D3 · Missing outcome data Some concerns about risk of bias | Same attrition as O1 and no outcome-specific additional loss is reported: 28/31 (90.3%) analysed, below the 20% prong; 13.3% vs 6.3% per arm, a 7.0-point difference that trips the per-arm prong, so PN to "available for nearly all", and GI-intolerance dropout makes value-dependent missingness plausible with no sensitivity analysis. Written override from the algorithm's High to Some concerns under calibration ruling 2 (only one prong trips; three participants). For IL-6 specifically the margin matters more than for CRP, since the reported p is exactly at the 0.05 boundary and the loss of two treated participants could move it either way; that fragility is recorded in limitations rather than as a further downgrade here.During the observed period, three patients were excluded from the study; two of them due to drug side effects (nausea, vomiting), and one patient due to exacerbation of the disease. IL-6 (pg/mL) 3.5 (2.3) 2.8 (1.1) 0.05 * 5.6 (12.2) 2.3 (3.6) 0.1 |
| D4 · Measurement of the outcome Low risk of bias | IL-6 was measured by ELISA with a single named commercial kit at a single named research centre, identically for both arms and both timepoints. The assay is objective and no change of kit or lot mid-study is reported. Per the collection rule this is Low; the kit is a research-centre ELISA rather than a certified central lab, but the rule's conditions (assay unchanged, same in both arms) are met on the evidence available.The serum levels of IL-1beta, IL-6, IL-17 and IL-23 were measured by means of the Enzyme Linked Immunosorbent Assay (ELISA) technique with commercial diagnostic kits BioLegend ELISA MAX Deluxe Sets (BioLegend, San Diego, CA, USA) and at the Center for Biomedical Research of the Faculty of Medicine of the University of Banja Luka. |
| D5 · Selection of the reported result High risk of bias | Prespecification unverifiable (no protocol or SAP retrieved; registration cited with a 2024 access date against a February 2023 ethics approval), and the reported selection is more pointed than for CRP: four cytokines were assayed (IL-1beta, IL-6, IL-17, IL-23), only the one with p = 0.05 is carried into the abstract and conclusions, IL-6 is omitted from the between-group comparison table that CRP and IL-23 receive, and the Discussion states the control IL-6 "was not changed" when Table 3 shows a larger median fall in the control arm (5.6 to 2.3) than in the treated arm (3.5 to 2.8). Selection of a favourable analysis and framing from multiple measured markers is affirmative rather than merely unverifiable; the "at least Some concerns" floor is exceeded.After the 12-week treatment with semaglutide, the level of IL-6 decreased significantly, while the level of IL-6 in the control group was not changed. IL-6 (pg/mL) 3.5 (2.3) 2.8 (1.1) 0.05 * 5.6 (12.2) 2.3 (3.6) 0.1 |
02Funding
Funding and conflicts
- Funding
- not reported in abstract
- Industry funded
- Unclear
- Manufacturer
- None identified
- Sponsor role
- not reported in abstract
- Author conflicts
- The authors declare no conflicts of interest.
- Independent replication
- unknown
Funding is shown on every study and never used to score it.
04Source
The source, as retrieved
Abstract
Psoriasis is a chronic inflammatory skin disease with relapsing nature. Estimates are that approximately 2-3% of the world's population suffers from this disease. More severe forms of psoriasis are conditions of high inflammation, which is confirmed by the clinical picture and numerous inflammatory parameters such as C-reactive protein (CRP), cytokines and homocysteine, which vary with disease activity. The objective of this clinical study was to investigate the effect of GLP-1 receptor agonist semaglutide therapy on pro-inflammatory factors in the serum and the severity of the clinical picture of psoriasis in obese patients with type 2 diabetes mellitus (T2DM) on chronic metformin therapy. This randomized clinical study was conducted on 31 psoriatic patients with T2DM that were randomized into two groups: one that received semaglutide during the 12-week trial (n = 15), while the second was control (n = 16). The results demonstrated that the severity of the clinical picture of psoriasis, determined by the Psoriasis Area and Severity Index (PASI) score, was significantly better after the administration of semaglutide (the median baseline PASI score in patients treated with semaglutide was 21 (IQR = 19.8), while after 12 weeks of therapy the score was 10 (IQR = 6; p = 0.002). Also, the quality of life in the group of patients who received the drug, measured by the Dermatology Life Quality Index (DLQI), improved significantly after 3 months (a median baseline DLQI score in the semaglutide group was 14 (IQR = 5) at the beginning of the study, and after 12 weeks of treatment the median DLQI score was 4 (IQR = 4; p = 0.002)). The use of semaglutide led to a significant decrease in pro-inflammatory cytokines in the serum (IL6), as well as a significant decrease in CRP values (p < 0.05). A significant decrease in the body mass index (BMI) value in the semaglutide-treated group was also identified, as well as a significant decrease in the level of low-density cholesterol (LDL) (p < 0.05). In conclusion, semaglutide, based on its systemic anti-inflammatory characteristics, could contribute to the treatment of psoriatic obese patients with T2DM.
Where this record came from
| Source | Retrieved | Identifier |
|---|---|---|
| pubmed | Sep 13, 2026 | 39858442 first ingestion |