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clinical-trials

Page 24 of 39 · 913 questions tagged clinical-trials.

913 questions · sorted by votes · page 24 of 39

16 votes5 answers8.5k views
What does STEP 2 actually establish about oral semaglutide?

Conditions: STEP 2 · oral semaglutide. 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,…

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 dana_wexler 15k · 11 months ago
16 votes 5 answers8.4k views
What did the placebo arm of SELECT report for nausea?

Details up front: SELECT · nausea. 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
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 Dr_Marek_Zielinski 39k · 10 months ago
16 votes2 answers8k views
What does PIONEER-1 report at the 5 mg dose level?

The specifics, since they change the answer: PIONEER-1 · 5 mg. I want to understand what this actually establishes, as opposed to what it is being used to imply. My…

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
sterile-water
sterile-water

Preservative-free sterile water for injection: appropriate for a single-withdrawal presentation, a poor choice for anything you intend to open…

14 questions
asked by k_szabo 45k · 6 months ago
16 votes 2 answers7.4k views
Does the ESSENCE population resemble anyone asking about semaglutide here?

The specifics, since they change the answer: ESSENCE · semaglutide. I have the document in front of me and I can read the numbers. What I cannot do is interpret them.…

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
asked by mala_venkatesh 21k · 18 months ago
16 votes 5 answers7.3k views
What does SOUL report at the 5 mg dose level?

The particulars: SOUL · 5 mg. 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 invited…

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 Dr_Ingrid_Baumgartner 39k · 9 months ago
16 votes 5 answers5.8k views
Is there any published stability data for cagrilintide at 2–8 °C?

Details up front: cagrilintide · 2–8 °C. I am asking for verification rather than opinion, ideally with something I can read myself. It is possible the evidence…

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 mg_per_ml 12k · 4 months ago
16 votes 1 answer4.4k views
What does TRIUMPH-3 report at the 20 mg dose level?

The particulars: TRIUMPH-3 · 20 mg. I have the document in front of me and I can read the numbers. What I cannot do is interpret them. I am reasonably comfortable…

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 tare_and_weigh 18k · 17 days ago
16 votes 3 answers3.6k views
Is 5 mg weekly a defensible maintenance dose for a GLP-1 receptor agonist?

Stated plainly: 5 mg · a GLP-1 receptor agonist. I am trying to build something sustainable rather than something thorough that I will abandon. I have already decided…

maintenance-dose
maintenance-dose

Staying put: the lowest dose that holds a result, the difference between the maximum studied dose and the maximum useful dose, and what the…

44 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 k_szabo 45k · 34 days ago
16 votes 4 answers2.3k views
Is there any published stability data for cagrilintide at minus 80 °C?

Numbers first: cagrilintide · minus 80 °C. I would rather be corrected now than propagate something wrong. I am specifically not interested in a testimonial; I am…

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 leonid_marchuk 15k · 7 days ago
15 votes 5 answers39k views
Is STEP 5 a fair comparison of a GLP-1 receptor agonist against its comparator arm?

Setup, so nobody has to ask: STEP 5 · a GLP-1 receptor agonist. This is asserted often enough that I assumed it was established, and then I went looking for the…

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 nynke_dekker 18k · 2.2 years ago
15 votes 5 answers38k views
What does FLOW report at the 4 mg dose level?

Setup, so nobody has to ask: FLOW · 4 mg. I have read the primary source rather than the summary, which has left me with more questions. I understand the headline. I…

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 marcus_thorbjorn 16k · 2.1 years ago
15 votes5 answers29k views
What does SURPASS-3 tell me about injection-site erythema at the 20 mg dose?

Concretely: SURPASS-3 · injection-site erythema · 20 mg. I would like to know the limits of what can be inferred from this. What I am trying to avoid is over-reading…

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 teodora_ilic 15k · 18 months ago
15 votes 5 answers26k views
What does SURMOUNT-5 tell me about fatigue at the 60 mg dose?

Conditions: SURMOUNT-5 · fatigue · 60 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
asked by shear_at_the_front 15k · 2.1 years ago
15 votes 5 answers23k views
Does the SURMOUNT-4 population resemble anyone asking about tirzepatide here?

The case in front of me: SURMOUNT-4 · tirzepatide. I would like to know the limits of what can be inferred from this. What I am trying to avoid is over-reading a…

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
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.…

14 questions
asked by ahmed_zerouali 19k · 2.2 years ago
15 votes0 answers21k views
Is SURPASS-3 a fair comparison of cagrilintide against its comparator arm?

Stated plainly: SURPASS-3 · cagrilintide. This is asserted often enough that I assumed it was established, and then I went looking for the source. I have searched the…

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 mala_venkatesh 21k · 2.2 years ago
15 votes 4 answers19k views
What does ESSENCE tell me about vomiting at the 5 mg dose?

Concretely: ESSENCE · vomiting · 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
asked by kwn_analytical 89k · 18 months ago
15 votes5 answers18k views
Does the ESSENCE population resemble anyone asking about oral semaglutide here?

The case in front of me: ESSENCE · oral semaglutide. The figures are clear enough; the question is what they mean and what they do not. I can supply the numbers if…

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
asked by gunnar_isaksen 16k · 13 months ago
15 votes5 answers11k views
Why do two papers on STEP 5 report different headline figures?

The clinician who ordered the panel was not concerned; I would still like to understand it. I keep seeing this stated as a fact with no explanation attached, and…

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
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
asked by Dr_Aoife_Brennan 50k · 9 months ago
15 votes 5 answers11k views
What does TRIUMPH-1 actually establish about a GLP-1 receptor agonist?

Stated plainly: TRIUMPH-1 · a GLP-1 receptor agonist. 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
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 ilaria_bertone 43k · 4 months ago
15 votes 5 answers11k views
What does the mechanism of cagrilintide predict that PIONEER-4 did not test?

Numbers first: cagrilintide · PIONEER-4. I suspect the usual explanation for this is wrong, or at least incomplete. I am aware this may have a boring answer. I would…

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 halvard_ness 42k · 4 months ago
15 votes5 answers9.9k views
What is biased agonism and does it matter clinically?

This matters because it predicts what a related molecule should do. This is one of those things that everyone repeats and nobody derives. This matters practically,…

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
ecnoglutide
ecnoglutide

A long-acting GLP-1 receptor agonist with a cAMP-biased signalling profile. A niche tag, mostly used for mechanism questions about biased agonism…

14 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 deamidation_watch 43k · 21 months ago
15 votes 5 answers9.7k views
Why do two papers on ESSENCE report different headline figures?

My laboratory results are from the same laboratory each time, drawn fasting, which I gather matters. I keep seeing this stated as a fact with no explanation attached,…

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
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
asked by dead_volume 49k · 3 months ago
15 votes 5 answers9.6k views
What is the reported incidence of reflux on ecnoglutide in TRIUMPH-3?

The specifics, since they change the answer: reflux · ecnoglutide · TRIUMPH-3. I want to understand what this actually establishes, as opposed to what it is being…

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 rukhsana_iqbal 14k · 14 months ago
15 votes0 answers8.7k views
Is a titration interval of two weeks better supported than four weeks for survodutide?

For reference: two weeks · survodutide. Somebody stated this to me confidently and I would like to check it before repeating it. I would accept a well-reasoned…

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
renal-outcomes
renal-outcomes

Kidney endpoints: the FLOW composite, eGFR slope as an endpoint, albuminuria regression, and why an early eGFR dip is expected rather than alarming.

14 questions
asked by forty_two_c 43k · 11 months ago