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clinical-trials

Page 14 of 39 · 913 questions tagged clinical-trials.

913 questions · sorted by votes · page 14 of 39

25 votes 1 answer5.9k views
What does TRIUMPH-3 report at the 5 mg dose level?

The particulars: TRIUMPH-3 · 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…

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 marta_szymanska 17k · 6 months ago
24 votes5 answers50k views
What did PIONEER-4 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 one_ml_bac 12k · 23 months ago
24 votes 5 answers44k views
Is PIONEER-4 a fair comparison of ecnoglutide against its comparator arm?

The specifics, since they change the answer: PIONEER-4 · ecnoglutide. 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 valentina_rossi 16k · 2.3 years ago
24 votes 5 answers43k views
What does SELECT tell me about early satiety at the 4 mg dose?

Details up front: SELECT · early satiety · 4 mg. 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…

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 cap_the_luer 15k · 23 months ago
24 votes5 answers35k views
What did the placebo arm of SURMOUNT-4 report for fatigue?

The case in front of me: SURMOUNT-4 · 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 rosa_mendieta 13k · 15 months ago
24 votes 4 answers34k views
What does the mechanism of liraglutide predict that SOUL did not test?

For reference: liraglutide · SOUL. I would like the mechanism, because I want to be able to reason about the cases nobody has written about. I have tried to reason it…

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 zainab_mustafa 16k · 2.2 years ago
24 votes 5 answers32k views
What is the reported incidence of early satiety on a GLP-1 receptor agonist in TRIUMPH-1?

Stated plainly: early satiety · a GLP-1 receptor agonist · TRIUMPH-1. I would like help reading this properly rather than being told what conclusion to reach. I have…

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 eighty_six_hours 16k · 18 months ago
24 votes 5 answers29k views
What is the reported incidence of reflux on retatrutide in SURMOUNT-3?

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

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
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 two_two_micron 15k · 17 months ago
24 votes0 answers27k views
Is 15 mg weekly a defensible maintenance dose for semaglutide?

For reference: 15 mg · semaglutide. I am at the decision point and I would rather think it through than improvise. I would rather spend money on measurement than on…

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 pascal_thibault 13k · 23 months ago
24 votes 5 answers26k views
What did the placebo arm of SOUL report for early satiety?

The specifics, since they change the answer: SOUL · early satiety. I want to understand what this actually establishes, as opposed to what it is being used to imply.…

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 micron22 36k · 2.0 years ago
24 votes5 answers26k views
What does the mechanism of retatrutide predict that SELECT did not test?

Stated plainly: retatrutide · SELECT. I keep seeing this stated as a fact with no explanation attached, and unexplained facts make me suspicious. My background is…

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 klara_novotna 16k · 16 months ago
24 votes0 answers26k views
How comparable are retatrutide and liraglutide on the evidence available?

Setup, so nobody has to ask: retatrutide · liraglutide. Both of these get recommended confidently by different people, which suggests neither is obviously right. My…

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 liam_bracken 12k · 18 months ago
24 votes 5 answers24k views
Does the SURMOUNT-2 population resemble anyone asking about orforglipron here?

Details up front: SURMOUNT-2 · orforglipron. 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…

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 · 9 months ago
24 votes 5 answers22k views
What does the mechanism of tirzepatide predict that STEP 4 did not test?

The particulars: tirzepatide · STEP 4. 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 dermot_kiely 14k · 22 months ago
24 votes0 answers22k views
What did the placebo arm of SURMOUNT-1 report for nausea?

What I have: SURMOUNT-1 · 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
thyroid
thyroid

Thyroid questions: the rodent C-cell findings behind the labelled warning, human calcitonin data, TSH drift during weight loss, and the…

14 questions
asked by lane_transit 42k · 2.1 years ago
24 votes0 answers22k views
What does REDEFINE-1 tell me about early satiety at the 50 mg dose?

Numbers first: REDEFINE-1 · early satiety · 50 mg. This is presented as though it settles something, and I am not convinced it does. I have two documents that appear…

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 ayo_fadipe 19k · 20 months ago
24 votes 3 answers20k views
What did the registration protocols actually do with participants who could not tolerate a titration step?

Every summary of these trials reports the result as though everyone in the active arm reached the assigned dose. "Semaglutide 2.4 mg produced 14.9 % weight loss." But…

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
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 cap_the_luer 15k · 18 months ago
24 votes0 answers17k views
What is the reported incidence of nausea on oral semaglutide in PIONEER-1?

The case in front of me: nausea · oral semaglutide · PIONEER-1. 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 linnea_wahlberg 14k · 13 months ago
24 votes 2 answers17k views
What does SURMOUNT-OSA tell me about nausea at the 2 mg dose?

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

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 zainab_mustafa 16k · 2.3 years ago
24 votes0 answers15k views
Is FLOW a fair comparison of liraglutide against its comparator arm?

Conditions: FLOW · liraglutide. I want to know whether there is evidence behind this or only repetition. I have checked the obvious registries and monographs without…

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 Dr_Idris_Coulibaly 40k · 8 months ago
24 votes1 answer13k views
Is SURMOUNT-1 a fair comparison of survodutide against its comparator arm?

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

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 bea_castellanos 47k · 7 months ago
24 votes5 answers12k views
What did PIONEER-1 do with participants who could not tolerate a step?

My records go back to the first dose with dates, so I can reconstruct the timeline exactly. The figures are clear enough; the question is what they mean and what they…

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 forty_units 14k · 8 months ago
24 votes 5 answers12k views
What does STEP 4 report at the 2.5 mg dose level?

Details up front: STEP 4 · 2.5 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…

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 t_oyelaran 41k · 4 months ago
24 votes0 answers12k views
Is STEP 3 a fair comparison of orforglipron against its comparator arm?

What I have: STEP 3 · orforglipron. I am asking for verification rather than opinion, ideally with something I can read myself. It is possible the evidence exists and…

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 ahmed_zerouali 19k · 6 months ago