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clinical-trials

Page 13 of 32 · 745 questions tagged clinical-trials.

745 questions · sorted by votes · page 13 of 32

23 votes0 answers31k views
What did ESSENCE actually show on fibrosis?

The clinician who ordered the panel was not concerned; I would still like to understand it. I would like help reading this properly rather than being told what…

mash
mash

Metabolic dysfunction-associated steatohepatitis: histological endpoints, resolution without worsening fibrosis, fibrosis improvement by stage,…

56 questions
clinical-trials
clinical-trials

Reading the primary literature properly: estimands, intention-to-treat versus per-protocol, confidence intervals, absolute versus relative…

745 questions
liver-enzymes
liver-enzymes

ALT, AST, GGT and ALP: what they do and do not indicate about hepatic fat, why enzymes are a poor surrogate for histology, and where non-invasive…

91 questions
asked by cake_collapsed 14k · 2.3 years ago
23 votes 5 answers28k views
What is the reported incidence of hair thinning on a GLP-1 receptor agonist in STEP 3?

Setup, so nobody has to ask: hair thinning · a GLP-1 receptor agonist · STEP 3. I would like help reading this properly rather than being told what conclusion to…

hair-loss
hair-loss

Telogen effluvium following rapid weight loss versus a drug-attributable effect: the timing signature that distinguishes them, protein and…

50 questions
clinical-trials
clinical-trials

Reading the primary literature properly: estimands, intention-to-treat versus per-protocol, confidence intervals, absolute versus relative…

745 questions
asked by gel_pack_warm 13k · 16 months ago
23 votes5 answers27k views
What does STEP 2 tell me about dizziness at the 1 mg dose?

Concretely: STEP 2 · dizziness · 1 mg. The figures are clear enough; the question is what they mean and what they do not. I can supply the numbers if the specifics…

clinical-trials
clinical-trials

Reading the primary literature properly: estimands, intention-to-treat versus per-protocol, confidence intervals, absolute versus relative…

745 questions
titration
titration

Stepwise dose increases over weeks, why the label schedules exist at all, and what tolerability-driven deviation from a schedule looks like in…

456 questions
asked by forty_two_c 66k · 2.3 years ago
23 votes 5 answers25k views
Does the SURPASS-2 population resemble anyone asking about tirzepatide here?

Setup, so nobody has to ask: SURPASS-2 · tirzepatide. I have read the primary source rather than the summary, which has left me with more questions. I understand the…

clinical-trials
clinical-trials

Reading the primary literature properly: estimands, intention-to-treat versus per-protocol, confidence intervals, absolute versus relative…

745 questions
harm-reduction
harm-reduction

Reducing avoidable risk where a decision has already been made: independent verification before use, sterility practice, dose arithmetic checked…

472 questions
semaglutide
semaglutide

A GLP-1 receptor agonist with a fatty-acid-acylated backbone and a roughly one-week half-life, marketed for type 2 diabetes and for weight…

470 questions
tirzepatide
tirzepatide

A dual GIP and GLP-1 receptor agonist. Questions here cover the SURPASS and SURMOUNT programmes, the practical differences from a pure GLP-1…

370 questions
asked by m_haraldsen 21k · 21 months ago
23 votes 5 answers25k views
Why do two papers on STEP 2 report different headline figures?

I have the full paper rather than the abstract, and the supplementary appendix. I understand the observation; what I do not understand is the mechanism behind it. I…

clinical-trials
clinical-trials

Reading the primary literature properly: estimands, intention-to-treat versus per-protocol, confidence intervals, absolute versus relative…

745 questions
dosing-math
dosing-math

The arithmetic itself: milligrams to millilitres to insulin units, concentration after reconstitution, dose per draw, and vial-days per vial. Show…

764 questions
semaglutide
semaglutide

A GLP-1 receptor agonist with a fatty-acid-acylated backbone and a roughly one-week half-life, marketed for type 2 diabetes and for weight…

470 questions
asked by w_okoye 43k · 9 months ago
23 votes 5 answers24k views
How comparable are mazdutide and tirzepatide on the evidence available?

Details up front: mazdutide · tirzepatide. I have used one of these for a while and I am considering switching, which requires a reason. What I care about is…

clinical-trials
clinical-trials

Reading the primary literature properly: estimands, intention-to-treat versus per-protocol, confidence intervals, absolute versus relative…

745 questions
semaglutide
semaglutide

A GLP-1 receptor agonist with a fatty-acid-acylated backbone and a roughly one-week half-life, marketed for type 2 diabetes and for weight…

470 questions
tirzepatide
tirzepatide

A dual GIP and GLP-1 receptor agonist. Questions here cover the SURPASS and SURMOUNT programmes, the practical differences from a pure GLP-1…

370 questions
mazdutide
mazdutide

A GLP-1 and glucagon receptor dual agonist developed primarily in China, with a distinct dose range and a fast-moving publication record.…

237 questions
asked by leonid_marchuk 19k · 12 months ago
23 votes 5 answers18k views
What does FLOW tell me about dizziness at the 1 mg dose?

What I am working with: FLOW · dizziness · 1 mg. I have read the primary source rather than the summary, which has left me with more questions. I understand the…

clinical-trials
clinical-trials

Reading the primary literature properly: estimands, intention-to-treat versus per-protocol, confidence intervals, absolute versus relative…

745 questions
titration
titration

Stepwise dose increases over weeks, why the label schedules exist at all, and what tolerability-driven deviation from a schedule looks like in…

456 questions
asked by fiadh_cronin 58k · 2.4 years ago
23 votes 5 answers16k views
What did the placebo arm of ATTAIN-1 report for hair thinning?

Numbers first: ATTAIN-1 · hair thinning. I can parse the result. I am less sure what it licenses me to conclude. I have deliberately not looked at anyone else’s…

clinical-trials
clinical-trials

Reading the primary literature properly: estimands, intention-to-treat versus per-protocol, confidence intervals, absolute versus relative…

745 questions
hair-loss
hair-loss

Telogen effluvium following rapid weight loss versus a drug-attributable effect: the timing signature that distinguishes them, protein and…

50 questions
asked by fill_volume 22k · 19 months ago
23 votes 5 answers16k views
What does SUSTAIN-6 report at the 1 mg dose level?

Concretely: SUSTAIN-6 · 1 mg. I would like to know the limits of what can be inferred from this. What I am trying to avoid is over-reading a single result, which I…

clinical-trials
clinical-trials

Reading the primary literature properly: estimands, intention-to-treat versus per-protocol, confidence intervals, absolute versus relative…

745 questions
dosing-math
dosing-math

The arithmetic itself: milligrams to millilitres to insulin units, concentration after reconstitution, dose per draw, and vial-days per vial. Show…

764 questions
titration
titration

Stepwise dose increases over weeks, why the label schedules exist at all, and what tolerability-driven deviation from a schedule looks like in…

456 questions
asked by ruaidhri_o_shea 25k · 23 months ago
23 votes5 answers13k views
What does SELECT actually establish about semaglutide?

What I am working with: SELECT · semaglutide. I would like help reading this properly rather than being told what conclusion to reach. I have the full report…

clinical-trials
clinical-trials

Reading the primary literature properly: estimands, intention-to-treat versus per-protocol, confidence intervals, absolute versus relative…

745 questions
semaglutide
semaglutide

A GLP-1 receptor agonist with a fatty-acid-acylated backbone and a roughly one-week half-life, marketed for type 2 diabetes and for weight…

470 questions
cardiovascular
cardiovascular

Cardiovascular outcomes: the SELECT major-adverse-event result, SOUL, SUSTAIN 6 and REWIND, how to convert a hazard ratio into an absolute risk…

68 questions
asked by nominal_ten 12k · 8 months ago
23 votes 5 answers12k views
What does STEP 2 tell me about nausea at the 1 mg dose?

What I have: STEP 2 · nausea · 1 mg. This is presented as though it settles something, and I am not convinced it does. I have two documents that appear to disagree,…

clinical-trials
clinical-trials

Reading the primary literature properly: estimands, intention-to-treat versus per-protocol, confidence intervals, absolute versus relative…

745 questions
nausea
nausea

The dominant tolerability signal in every trial of the class: incidence, timing relative to a dose step, duration, and the distinction between…

55 questions
titration
titration

Stepwise dose increases over weeks, why the label schedules exist at all, and what tolerability-driven deviation from a schedule looks like in…

456 questions
asked by aine_mulcahy 28k · 5 months ago
23 votes 5 answers11k views
What does SURMOUNT-4 actually establish about tirzepatide?

Numbers first: SURMOUNT-4 · tirzepatide. This is presented as though it settles something, and I am not convinced it does. I have two documents that appear to…

clinical-trials
clinical-trials

Reading the primary literature properly: estimands, intention-to-treat versus per-protocol, confidence intervals, absolute versus relative…

745 questions
semaglutide
semaglutide

A GLP-1 receptor agonist with a fatty-acid-acylated backbone and a roughly one-week half-life, marketed for type 2 diabetes and for weight…

470 questions
cardiovascular
cardiovascular

Cardiovascular outcomes: the SELECT major-adverse-event result, SOUL, SUSTAIN 6 and REWIND, how to convert a hazard ratio into an absolute risk…

68 questions
tirzepatide
tirzepatide

A dual GIP and GLP-1 receptor agonist. Questions here cover the SURPASS and SURMOUNT programmes, the practical differences from a pure GLP-1…

370 questions
asked by harriet_lonsdale 35k · 2 months ago
23 votes5 answers9.9k views
How comparable are retatrutide and survodutide on the evidence available?

For reference: retatrutide · survodutide. I suspect the honest answer is that it depends, in which case I would like to know on what. Assume I can obtain either…

clinical-trials
clinical-trials

Reading the primary literature properly: estimands, intention-to-treat versus per-protocol, confidence intervals, absolute versus relative…

745 questions
semaglutide
semaglutide

A GLP-1 receptor agonist with a fatty-acid-acylated backbone and a roughly one-week half-life, marketed for type 2 diabetes and for weight…

470 questions
tirzepatide
tirzepatide

A dual GIP and GLP-1 receptor agonist. Questions here cover the SURPASS and SURMOUNT programmes, the practical differences from a pure GLP-1…

370 questions
retatrutide
retatrutide

An investigational GLP-1, GIP and glucagon receptor tri-agonist, studied in the TRIUMPH programme. Not approved anywhere. Use this tag for…

251 questions
survodutide
survodutide

A GLP-1 and glucagon receptor dual agonist with a substantial published MASH dataset. Use this tag for its hepatic endpoints, its dose ladder, and…

225 questions
asked by cake_intact 17k · 6 months ago
23 votes3 answers8.9k views
What does orforglipron being a non-peptide small molecule change, practically?

Orforglipron is described as a non-peptide oral GLP-1 receptor agonist, which I take to mean it is a conventional small molecule rather than a peptide with a delivery…

orforglipron
orforglipron

A non-peptide, orally bioavailable small-molecule GLP-1 receptor agonist studied in the ATTAIN programme. It is not a peptide, which changes…

219 questions
oral-glp1
oral-glp1

Oral routes for GLP-1 receptor agonism: peptide formulations rescued by absorption enhancers such as SNAC, and true small molecules that need no…

219 questions
clinical-trials
clinical-trials

Reading the primary literature properly: estimands, intention-to-treat versus per-protocol, confidence intervals, absolute versus relative…

745 questions
glp1-mechanism
glp1-mechanism

Receptor-level pharmacology: GLP-1R as a class B GPCR, cAMP and PKA signalling, biased agonism, internalisation and resensitisation, and the…

132 questions
asked by ruaidhri_o_shea 25k · 9 months ago
23 votes4 answers7.6k views
What does SELECT report at the 1 mg dose level?

What I am working with: SELECT · 1 mg. I would like help reading this properly rather than being told what conclusion to reach. I have the full report including the…

clinical-trials
clinical-trials

Reading the primary literature properly: estimands, intention-to-treat versus per-protocol, confidence intervals, absolute versus relative…

745 questions
dosing-math
dosing-math

The arithmetic itself: milligrams to millilitres to insulin units, concentration after reconstitution, dose per draw, and vial-days per vial. Show…

764 questions
titration
titration

Stepwise dose increases over weeks, why the label schedules exist at all, and what tolerability-driven deviation from a schedule looks like in…

456 questions
asked by sunniva_dahl 22k · 5 months ago
23 votes0 answers4.8k views
Is STEP 4 a fair comparison of semaglutide against its comparator arm?

Numbers first: STEP 4 · semaglutide. I am asking for verification rather than opinion, ideally with something I can read myself. It is possible the evidence exists…

clinical-trials
clinical-trials

Reading the primary literature properly: estimands, intention-to-treat versus per-protocol, confidence intervals, absolute versus relative…

745 questions
semaglutide
semaglutide

A GLP-1 receptor agonist with a fatty-acid-acylated backbone and a roughly one-week half-life, marketed for type 2 diabetes and for weight…

470 questions
tirzepatide
tirzepatide

A dual GIP and GLP-1 receptor agonist. Questions here cover the SURPASS and SURMOUNT programmes, the practical differences from a pure GLP-1…

370 questions
asked by tare_weight 60k · 5 months ago
22 votes 5 answers33k views
What does STEP 1 tell me about vomiting at the 2 mg dose?

Stated plainly: STEP 1 · vomiting · 2 mg. I would like help reading this properly rather than being told what conclusion to reach. I have the full report including…

clinical-trials
clinical-trials

Reading the primary literature properly: estimands, intention-to-treat versus per-protocol, confidence intervals, absolute versus relative…

745 questions
vomiting
vomiting

Emesis as a reported adverse event: trial incidence, its relationship to dose escalation rate, dehydration risk, and when it stops being a…

57 questions
titration
titration

Stepwise dose increases over weeks, why the label schedules exist at all, and what tolerability-driven deviation from a schedule looks like in…

456 questions
asked by elke_brunner 17k · 19 months ago
22 votes5 answers23k views
What is the reported incidence of vomiting on tirzepatide in SURPASS-3?

Details up front: vomiting · tirzepatide · SURPASS-3. This is presented as though it settles something, and I am not convinced it does. I have two documents that…

vomiting
vomiting

Emesis as a reported adverse event: trial incidence, its relationship to dose escalation rate, dehydration risk, and when it stops being a…

57 questions
clinical-trials
clinical-trials

Reading the primary literature properly: estimands, intention-to-treat versus per-protocol, confidence intervals, absolute versus relative…

745 questions
tirzepatide
tirzepatide

A dual GIP and GLP-1 receptor agonist. Questions here cover the SURPASS and SURMOUNT programmes, the practical differences from a pure GLP-1…

370 questions
asked by bea_forsberg 11k · 11 months ago
22 votes 5 answers17k views
How do I convert the ESSENCE hazard ratio into an absolute risk reduction?

I have three data points across nine months, which I hope is enough to see a trend. I would rather understand the derivation than memorise the outcome. Two people I…

cardiovascular
cardiovascular

Cardiovascular outcomes: the SELECT major-adverse-event result, SOUL, SUSTAIN 6 and REWIND, how to convert a hazard ratio into an absolute risk…

68 questions
clinical-trials
clinical-trials

Reading the primary literature properly: estimands, intention-to-treat versus per-protocol, confidence intervals, absolute versus relative…

745 questions
dosing-math
dosing-math

The arithmetic itself: milligrams to millilitres to insulin units, concentration after reconstitution, dose per draw, and vial-days per vial. Show…

764 questions
asked by sample_id 17k · 5 months ago
22 votes 3 answers16k views
Did any trial in this class ever test a split weekly schedule, or a different dosing frequency at all?

I have looked for a randomised comparison of dosing frequency within a single molecule in this class and cannot find one. Every phase 3 trial I can find fixed the…

split-dosing
split-dosing

Dividing a weekly dose across more than one administration. Questions here concern the pharmacokinetic rationale, whether the peak-to-trough ratio…

44 questions
clinical-trials
clinical-trials

Reading the primary literature properly: estimands, intention-to-treat versus per-protocol, confidence intervals, absolute versus relative…

745 questions
semaglutide
semaglutide

A GLP-1 receptor agonist with a fatty-acid-acylated backbone and a roughly one-week half-life, marketed for type 2 diabetes and for weight…

470 questions
liraglutide
liraglutide

A once-daily GLP-1 receptor agonist and the compound that established the class. Still relevant for its shorter half-life, its paediatric and…

235 questions
asked by juliette_farnese 13k · 5 months ago
22 votes0 answers15k views
Is there any published stability data for mazdutide at 30 °C?

What I have: mazdutide · 30 °C. I would rather be corrected now than propagate something wrong. I am specifically not interested in a testimonial; I am interested in…

peptide-stability
peptide-stability

The chemistry of peptide degradation: deamidation, oxidation, hydrolysis, aggregation and fibrillation, and how temperature, pH, ionic strength,…

908 questions
storage
storage

Storage conditions and their evidence base: minus twenty degrees for powder, refrigerated for solution, protection from light, and what the…

701 questions
clinical-trials
clinical-trials

Reading the primary literature properly: estimands, intention-to-treat versus per-protocol, confidence intervals, absolute versus relative…

745 questions
mazdutide
mazdutide

A GLP-1 and glucagon receptor dual agonist developed primarily in China, with a distinct dose range and a fast-moving publication record.…

237 questions
asked by dana_wexler 11k · 9 months ago
22 votes 5 answers15k views
Is there any published stability data for dulaglutide at room temperature?

Stated plainly: dulaglutide · room temperature. This has the shape of a fact but I cannot find its origin. What I found instead were three secondary sources all…

peptide-stability
peptide-stability

The chemistry of peptide degradation: deamidation, oxidation, hydrolysis, aggregation and fibrillation, and how temperature, pH, ionic strength,…

908 questions
storage
storage

Storage conditions and their evidence base: minus twenty degrees for powder, refrigerated for solution, protection from light, and what the…

701 questions
clinical-trials
clinical-trials

Reading the primary literature properly: estimands, intention-to-treat versus per-protocol, confidence intervals, absolute versus relative…

745 questions
dulaglutide
dulaglutide

A once-weekly GLP-1 receptor agonist built on an Fc fusion rather than fatty-acid acylation. Use this tag for questions about the fusion-protein…

200 questions
asked by plunger_stop 13k · 10 months ago
22 votes 3 answers14k views
What does SURPASS-2 tell me about hair thinning at the 15 mg dose?

The specifics, since they change the answer: SURPASS-2 · hair thinning · 15 mg. I want to understand what this actually establishes, as opposed to what it is being…

clinical-trials
clinical-trials

Reading the primary literature properly: estimands, intention-to-treat versus per-protocol, confidence intervals, absolute versus relative…

745 questions
hair-loss
hair-loss

Telogen effluvium following rapid weight loss versus a drug-attributable effect: the timing signature that distinguishes them, protein and…

50 questions
titration
titration

Stepwise dose increases over weeks, why the label schedules exist at all, and what tolerability-driven deviation from a schedule looks like in…

456 questions
asked by kirsi_lahtinen 25k · 5 months ago
22 votes 5 answers13k views
What is the reported incidence of fatigue on oral semaglutide in PIONEER-4?

The particulars: fatigue · oral semaglutide · PIONEER-4. I want to understand what this actually establishes, as opposed to what it is being used to imply. My concern…

fatigue
fatigue

Tiredness on treatment: how much is energy deficit, how much is dehydration or electrolyte drift, how much is genuinely drug-attributable, and…

78 questions
clinical-trials
clinical-trials

Reading the primary literature properly: estimands, intention-to-treat versus per-protocol, confidence intervals, absolute versus relative…

745 questions
oral-glp1
oral-glp1

Oral routes for GLP-1 receptor agonism: peptide formulations rescued by absorption enhancers such as SNAC, and true small molecules that need no…

219 questions
asked by seamus_brady 15k · 10 months ago