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clinical-trials

Page 13 of 39 · 913 questions tagged clinical-trials.

913 questions · sorted by votes · page 13 of 39

25 votes 5 answers35k views
Is STEP 3 a fair comparison of tirzepatide against its comparator arm?

Concretely: STEP 3 · tirzepatide. I want to know whether there is evidence behind this or only repetition. I have checked the obvious registries and monographs…

clinical-trials
clinical-trials

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

913 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…

360 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…

162 questions
asked by juliette_farnese 12k · 23 months ago
25 votes 5 answers34k views
How do I convert the SURPASS-3 hazard ratio into an absolute risk reduction?

I have the full paper rather than the abstract, and the supplementary appendix. I can do the algebra. I am not confident about the conversion factors. If there is a…

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…

111 questions
clinical-trials
clinical-trials

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

913 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…

811 questions
asked by nils_karlberg 13k · 15 months ago
25 votes 5 answers33k views
What is the reported incidence of hair thinning on tirzepatide in FLOW?

The case in front of me: hair thinning · tirzepatide · FLOW. The figures are clear enough; the question is what they mean and what they do not. I can supply the…

gi-side-effects
gi-side-effects

The gastrointestinal cluster as a whole - nausea, vomiting, diarrhoea, constipation, reflux, early satiety - with trial incidence rates, dropout…

416 questions
clinical-trials
clinical-trials

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

913 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…

346 questions
asked by mg_per_ml 12k · 2.2 years ago
25 votes 4 answers32k views
What did the placebo arm of SELECT report for fatigue?

Concretely: SELECT · fatigue. The figures are clear enough; the question is what they mean and what they do not. I can supply the numbers if the specifics change the…

clinical-trials
clinical-trials

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

913 questions
gi-side-effects
gi-side-effects

The gastrointestinal cluster as a whole - nausea, vomiting, diarrhoea, constipation, reflux, early satiety - with trial incidence rates, dropout…

416 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…

346 questions
asked by charge_state_3 39k · 22 months ago
25 votes 5 answers29k views
Does the SUSTAIN-6 population resemble anyone asking about dulaglutide here?

What I have: SUSTAIN-6 · dulaglutide. 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…

913 questions
harm-reduction
harm-reduction

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

445 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…

360 questions
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…

14 questions
asked by ellis_thorne 17k · 11 months ago
25 votes 5 answers28k views
Is a titration interval of ten weeks better supported than four weeks for a GLP-1 receptor agonist?

What I am working with: ten weeks · a GLP-1 receptor agonist. This has the shape of a fact but I cannot find its origin. What I found instead were three secondary…

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…

444 questions
dose-escalation
dose-escalation

The decision to move up a step: what evidence supports a four-week interval, what happens when you compress it, and how trial protocols handled…

88 questions
clinical-trials
clinical-trials

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

913 questions
asked by claudia_ferrante 46k · 17 months ago
25 votes 5 answers27k views
What is the reported incidence of hair thinning on tirzepatide in STEP 3?

The case in front of me: hair thinning · tirzepatide · STEP 3. I would like to know the limits of what can be inferred from this. What I am trying to avoid is…

gi-side-effects
gi-side-effects

The gastrointestinal cluster as a whole - nausea, vomiting, diarrhoea, constipation, reflux, early satiety - with trial incidence rates, dropout…

416 questions
clinical-trials
clinical-trials

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

913 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…

346 questions
asked by per_haugen 18k · 16 months ago
25 votes 5 answers24k views
What did the placebo arm of SURMOUNT-2 report for fatigue?

The case in front of me: SURMOUNT-2 · fatigue. 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…

clinical-trials
clinical-trials

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

913 questions
gi-side-effects
gi-side-effects

The gastrointestinal cluster as a whole - nausea, vomiting, diarrhoea, constipation, reflux, early satiety - with trial incidence rates, dropout…

416 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…

346 questions
asked by cap_the_luer 15k · 20 months ago
25 votes 5 answers24k views
What is the reported incidence of early satiety on oral semaglutide in SURMOUNT-2?

Concretely: early satiety · oral semaglutide · SURMOUNT-2. The figures are clear enough; the question is what they mean and what they do not. I can supply the numbers…

gi-side-effects
gi-side-effects

The gastrointestinal cluster as a whole - nausea, vomiting, diarrhoea, constipation, reflux, early satiety - with trial incidence rates, dropout…

416 questions
clinical-trials
clinical-trials

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

913 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…

346 questions
asked by mira_sundqvist 19k · 2.1 years ago
25 votes5 answers23k views
What did ATTAIN-1 do with participants who could not tolerate a step?

I am asking about the protocol logic rather than about my own case specifically. I want to understand what this actually establishes, as opposed to what it is being…

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…

444 questions
clinical-trials
clinical-trials

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

913 questions
gi-side-effects
gi-side-effects

The gastrointestinal cluster as a whole - nausea, vomiting, diarrhoea, constipation, reflux, early satiety - with trial incidence rates, dropout…

416 questions
asked by lucia_marchetti 18k · 10 months ago
25 votes 5 answers21k views
What is the reported incidence of injection-site erythema on retatrutide in PIONEER-4?

What I have: injection-site erythema · retatrutide · PIONEER-4. I can parse the result. I am less sure what it licenses me to conclude. I have deliberately not looked…

gi-side-effects
gi-side-effects

The gastrointestinal cluster as a whole - nausea, vomiting, diarrhoea, constipation, reflux, early satiety - with trial incidence rates, dropout…

416 questions
clinical-trials
clinical-trials

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

913 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…

346 questions
asked by tess_amankwah 48k · 8 months ago
25 votes 5 answers20k views
What did the placebo arm of STEP 2 report for dizziness?

Setup, so nobody has to ask: STEP 2 · dizziness. 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…

913 questions
gi-side-effects
gi-side-effects

The gastrointestinal cluster as a whole - nausea, vomiting, diarrhoea, constipation, reflux, early satiety - with trial incidence rates, dropout…

416 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…

346 questions
injection-site-reaction
injection-site-reaction

Local reactions: erythema, induration, pruritus and nodules. Their relationship to injection depth, diluent composition, benzyl alcohol…

14 questions
asked by lipid_panel_q 44k · 23 months ago
25 votes5 answers19k views
What does the mechanism of oral semaglutide predict that SELECT did not test?

The particulars: oral semaglutide · SELECT. I would like the mechanism, because I want to be able to reason about the cases nobody has written about. I have tried to…

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…

175 questions
clinical-trials
clinical-trials

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

913 questions
gip-receptor
gip-receptor

GIP receptor pharmacology, and the still-unsettled question of whether agonism or antagonism at GIPR is the metabolically useful direction.…

83 questions
asked by lyoph_cake 95k · 12 months ago
25 votes 5 answers17k views
What does SUSTAIN-6 actually establish about semaglutide?

The particulars: SUSTAIN-6 · semaglutide. I want to understand what this actually establishes, as opposed to what it is being used to imply. My concern is that I am…

clinical-trials
clinical-trials

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

913 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…

360 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…

111 questions
asked by second_lot 11k · 13 months ago
25 votes5 answers17k views
Is SELECT a fair comparison of liraglutide against its comparator arm?

Concretely: SELECT · liraglutide. The claim is plausible, which is exactly why I want to check it. I am able to read a paper if someone points me at one. Can anyone…

clinical-trials
clinical-trials

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

913 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…

360 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…

162 questions
cagrisema
cagrisema

A fixed-ratio combination of cagrilintide, a long-acting amylin analogue, with semaglutide, studied in the REDEFINE programme. Questions here…

14 questions
asked by bridget_nyathi 16k · 23 months ago
25 votes 2 answers16k views
Is TRIUMPH-1 a fair comparison of survodutide against its comparator arm?

The specifics, since they change the answer: TRIUMPH-1 · survodutide. Somebody stated this to me confidently and I would like to check it before repeating it. I would…

clinical-trials
clinical-trials

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

913 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…

360 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…

162 questions
asked by g_paskevicius 44k · 6 months ago
25 votes 5 answers16k views
What does FLOW tell me about injection-site erythema at the 10 mg dose?

What I am working with: FLOW · injection-site erythema · 10 mg. I have read the primary source rather than the summary, which has left me with more questions. I…

clinical-trials
clinical-trials

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

913 questions
gi-side-effects
gi-side-effects

The gastrointestinal cluster as a whole - nausea, vomiting, diarrhoea, constipation, reflux, early satiety - with trial incidence rates, dropout…

416 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…

444 questions
asked by jana_horakova 15k · 7 months ago
25 votes 4 answers15k views
What does PIONEER-4 tell me about headache at the 2 mg dose?

The specifics, since they change the answer: PIONEER-4 · headache · 2 mg. I have the document in front of me and I can read the numbers. What I cannot do is interpret…

clinical-trials
clinical-trials

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

913 questions
gi-side-effects
gi-side-effects

The gastrointestinal cluster as a whole - nausea, vomiting, diarrhoea, constipation, reflux, early satiety - with trial incidence rates, dropout…

416 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…

444 questions
asked by ravenna_pace 13k · 7 months ago
25 votes 5 answers13k views
Does the FLOW population resemble anyone asking about semaglutide here?

For reference: FLOW · semaglutide. I want to understand what this actually establishes, as opposed to what it is being used to imply. My concern is that I am being…

clinical-trials
clinical-trials

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

913 questions
harm-reduction
harm-reduction

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

445 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…

360 questions
pcos
pcos

Polycystic ovary syndrome: insulin resistance as the shared mechanism, ovulatory and menstrual outcomes reported on treatment, androgen changes,…

14 questions
asked by juliette_farnese 12k · 13 months ago
25 votes 4 answers10k views
How comparable are oral semaglutide and mazdutide on the evidence available?

The specifics, since they change the answer: oral semaglutide · mazdutide. I am trying to choose between two options that are usually discussed as though only one…

clinical-trials
clinical-trials

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

913 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…

360 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…

162 questions
asked by zeynep_arslan 20k · 5 months ago
25 votes0 answers9.5k views
What does STEP 4 tell me about fatigue at the 5 mg dose?

Conditions: STEP 4 · fatigue · 5 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…

913 questions
gi-side-effects
gi-side-effects

The gastrointestinal cluster as a whole - nausea, vomiting, diarrhoea, constipation, reflux, early satiety - with trial incidence rates, dropout…

416 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…

444 questions
injection-site-reaction
injection-site-reaction

Local reactions: erythema, induration, pruritus and nodules. Their relationship to injection depth, diluent composition, benzyl alcohol…

14 questions
pcos
pcos

Polycystic ovary syndrome: insulin resistance as the shared mechanism, ovulatory and menstrual outcomes reported on treatment, androgen changes,…

14 questions
asked by cake_collapsed 13k · 13 months ago
25 votes5 answers8.4k views
What does SURMOUNT-5 report at the 40 mg dose level?

What I have: SURMOUNT-5 · 40 mg. This is presented as though it settles something, and I am not convinced it does. I have two documents that appear to disagree, which…

clinical-trials
clinical-trials

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

913 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…

811 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…

444 questions
asked by kirsi_lahtinen 45k · 7 months ago
25 votes 3 answers8.2k views
What do the MASH histological endpoints actually mean, and why are they always paired?

Every trial in metabolic dysfunction-associated steatohepatitis reports two co-primary endpoints with oddly constructed names: "resolution of steatohepatitis without…

mash
mash

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

51 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…

360 questions
clinical-trials
clinical-trials

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

913 questions
asked by jo_vandeberg 19k · 14 months ago
25 votes 5 answers7.4k views
Is there any published stability data for ecnoglutide at 37 °C?

The case in front of me: ecnoglutide · 37 °C. I want to know whether there is evidence behind this or only repetition. I have checked the obvious registries and…

peptide-stability
peptide-stability

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

832 questions
storage
storage

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

646 questions
clinical-trials
clinical-trials

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

913 questions
asked by felix_araya 17k · 10 months ago