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clinical-trials

Page 17 of 39 · 913 questions tagged clinical-trials.

913 questions · sorted by votes · page 17 of 39

22 votes 5 answers15k views
Is there any published stability data for dulaglutide at room temperature?

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

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 plunger_stop 18k · 10 months ago
22 votes 3 answers14k views
What does SURPASS-2 tell me about hair thinning at the 8 mg dose?

The specifics, since they change the answer: SURPASS-2 · hair thinning · 8 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…

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 kirsi_lahtinen 45k · 5 months ago
22 votes 5 answers13k views
What is the reported incidence of fatigue on ecnoglutide in PIONEER-4?

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

Endocrine changes accompanying substantial weight loss: sex hormone binding globulin, testosterone, oestradiol, cortisol and the reproductive…

14 questions
asked by seamus_brady 17k · 10 months ago
22 votes0 answers11k views
What does REDEFINE-1 report at the 10 mg dose level?

Numbers first: REDEFINE-1 · 10 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 cal_hennessy 14k · 16 months ago
22 votes 5 answers10k views
What does STEP 5 report at the 8 mg dose level?

The case in front of me: STEP 5 · 8 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,…

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 coldpack_88 37k · 8 months ago
22 votes 5 answers9.9k views
Why do two papers on STEP 3 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…

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 helena_vidmar 18k · 11 months ago
22 votes 5 answers9k views
What did the placebo arm of FLOW report for early satiety?

For reference: FLOW · early satiety. 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
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 second_lot 11k · 37 days ago
22 votes4 answers8.7k views
What does PIONEER-1 tell me about constipation at the 15 mg dose?

Details up front: PIONEER-1 · constipation · 15 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
gallbladder
gallbladder

Cholelithiasis and cholecystitis risk during rapid weight loss and on treatment: how much is attributable to the rate of loss versus to the drug,…

14 questions
asked by net_peptide 16k · 39 days ago
22 votes 5 answers8k views
What is the reported incidence of headache on cagrilintide in STEP 2?

Setup, so nobody has to ask: headache · cagrilintide · STEP 2. I would like help reading this properly rather than being told what conclusion to reach. I have 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 felix_araya 17k · 4 months ago
22 votes0 answers7.9k views
Does the STEP 5 population resemble anyone asking about mazdutide here?

Setup, so nobody has to ask: STEP 5 · mazdutide. 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
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 Dr_Fatima_Belkacem 52k · 6 months ago
22 votes 5 answers7.6k views
What does the withdrawal-extension data say about regain trajectory?

Scale weight, waist circumference and a repetition maximum, all logged weekly. I would like help reading this properly rather than being told what conclusion to…

weight-regain
weight-regain

Regain after stopping or reducing: the trajectory reported in the withdrawal extensions, how much is fluid, and what the maintenance arms tell us…

14 questions
discontinuation
discontinuation

Stopping treatment: tapering versus abrupt cessation, what the trial withdrawal arms measured, clinically driven stops, and the practical planning…

21 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 · 6 months ago
22 votes 5 answers7.1k views
Is STEP 2 a fair comparison of survodutide against its comparator arm?

The specifics, since they change the answer: STEP 2 · 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 jana_horakova 15k · 5 months ago
22 votes0 answers5.3k views
What does STEP 3 report at the 60 mg dose level?

The particulars: STEP 3 · 60 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 with…

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 seven_day_half 16k · 4 months ago
21 votes5 answers44k views
What did SURPASS-2 do with participants who could not tolerate a step?

I am asking about the protocol logic rather than about my own case specifically. I can parse the result. I am less sure what it licenses me to conclude. I have…

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 mass_shift_18 14k · 2.1 years ago
21 votes 5 answers42k views
What does the mechanism of oral semaglutide predict that PIONEER-4 did not test?

For reference: oral semaglutide · PIONEER-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 h_villanueva 50k · 2.0 years ago
21 votes 5 answers39k views
What does PIONEER-4 actually establish about semaglutide?

The particulars: PIONEER-4 · semaglutide. I have the document in front of me and I can read the numbers. What I cannot do is interpret them. I am reasonably…

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 tenth_of_a_unit 40k · 20 months ago
21 votes0 answers27k views
What does REDEFINE-1 actually establish about survodutide?

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

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 deamidation_watch 43k · 23 months ago
21 votes0 answers26k views
What is the reported incidence of vomiting at the top studied dose?

It has now persisted for three weeks, which is what moved this from tolerable to worth asking about. This is presented as though it settles something, and I am not…

vomiting
vomiting

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

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
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 wren_calloway 14k · 2.1 years ago
21 votes 5 answers24k views
What did the placebo arm of FLOW report for constipation?

Details up front: FLOW · constipation. 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 syringe_ninety 15k · 2.1 years ago
21 votes 5 answers22k views
What does STEP 8 report at the 60 mg dose level?

The specifics, since they change the answer: STEP 8 · 60 mg. I have the document in front of me and I can read the numbers. What I cannot do is interpret them. 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
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 tess_amankwah 48k · 2.3 years ago
21 votes 4 answers22k views
Is SOUL a fair comparison of liraglutide against its comparator arm?

Concretely: SOUL · 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. Is there data…

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 amara_nwachukwu 41k · 13 months ago
21 votes 4 answers21k views
Is there any published stability data for orforglipron at 4 °C?

Setup, so nobody has to ask: orforglipron · 4 °C. This is asserted often enough that I assumed it was established, and then I went looking for the source. I have…

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 leah_ferrers 15k · 16 months ago
21 votes 5 answers18k views
Why do two papers on SURPASS-3 report different headline figures?

I have the full paper rather than the abstract, and the supplementary appendix. I would like the mechanism, because I want to be able to reason about the cases nobody…

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 halvard_ness 42k · 15 months ago
21 votes5 answers17k views
What is the reported incidence of dizziness on ecnoglutide in REDEFINE-1?

The specifics, since they change the answer: dizziness · ecnoglutide · REDEFINE-1. I have the document in front of me and I can read the numbers. What I cannot do 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
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 felix_araya 17k · 6 months ago