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clinical-trials

Page 14 of 32 · 745 questions tagged clinical-trials.

745 questions · sorted by votes · page 14 of 32

22 votes0 answers11k views
What does REDEFINE-1 report at the 2.4 mg dose level?

Numbers first: REDEFINE-1 · 2.4 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
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 cal_hennessy 17k · 16 months ago
22 votes 5 answers10k views
What does STEP 5 report at the 2 mg dose level?

The case in front of me: STEP 5 · 2 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…

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 coldpack_88 50k · 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…

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 helena_vidmar 8.5k · 11 months ago
22 votes 5 answers9k views
What did the placebo arm of FLOW report for early satiety?

Stated plainly: 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…

745 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…

162 questions
asked by second_lot 9.4k · 37 days ago
22 votes4 answers8.7k views
What does PIONEER-1 tell me about constipation at the 7 mg dose?

Details up front: PIONEER-1 · constipation · 7 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…

745 questions
constipation
constipation

Slowed transit as a consequence of delayed gastric emptying and reduced intake: incidence figures, fibre and hydration evidence, and why it often…

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 net_peptide 12k · 39 days ago
22 votes0 answers7.9k views
Does the STEP 5 population resemble anyone asking about semaglutide here?

Setup, so nobody has to ask: STEP 5 · 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
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
asked by Dr_Fatima_Belkacem 18k · 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…

10 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…

745 questions
asked by felix_araya 6.8k · 6 months ago
22 votes 5 answers7.1k views
Is STEP 2 a fair comparison of semaglutide against its comparator arm?

The specifics, since they change the answer: STEP 2 · semaglutide. 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…

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 jana_horakova 10k · 5 months ago
22 votes 3 answers4.7k views
What does SURMOUNT-2 report at the 10 mg dose level?

What I am working with: SURMOUNT-2 · 10 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
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 haze_check 9.3k · 3 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…

456 questions
clinical-trials
clinical-trials

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

745 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…

162 questions
asked by mass_shift_18 9.7k · 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…

132 questions
clinical-trials
clinical-trials

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

745 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.…

34 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 h_villanueva 70k · 2.0 years ago
21 votes 5 answers41k views
How much of an AHI improvement is neck-circumference change?

I am reading the trial table rather than the press release, which is why the numbers differ. I understand the observation; what I do not understand is the mechanism…

sleep-apnea
sleep-apnea

Obstructive sleep apnoea and the apnoea-hypopnoea index response to weight loss, including the SURMOUNT-OSA dataset and the question of whether…

6 questions
clinical-trials
clinical-trials

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

745 questions
lean-mass
lean-mass

Lean body mass as measured rather than assumed: what DEXA, BIA and air-displacement plethysmography each actually estimate, the body-composition…

127 questions
asked by sample_id 17k · 19 months ago
21 votes 5 answers39k views
What does PIONEER-4 actually establish about oral semaglutide?

The particulars: PIONEER-4 · oral 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…

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
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 tenth_of_a_unit 57k · 20 months ago
21 votes 5 answers32k views
Is 24 mg weekly a defensible maintenance dose for orforglipron?

Numbers first: 24 mg · orforglipron. This is a planning question. I know what my options are; I do not know how to weigh them. What I want is the minimum viable…

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…

54 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
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
asked by rhian_prydderch 23k · 2.0 years 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…

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
gi-side-effects
gi-side-effects

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

162 questions
asked by wren_calloway 23k · 2.1 years ago
21 votes 5 answers24k views
What did the placebo arm of FLOW report for constipation?

What I am working with: FLOW · constipation. 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
constipation
constipation

Slowed transit as a consequence of delayed gastric emptying and reduced intake: incidence figures, fibre and hydration evidence, and why it often…

55 questions
asked by syringe_ninety 12k · 2.1 years ago
21 votes 5 answers22k views
What does STEP 8 report at the 2 mg dose level?

The specifics, since they change the answer: STEP 8 · 2 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…

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 tess_amankwah 22k · 2.3 years ago
21 votes 4 answers22k views
Is SOUL a fair comparison of oral semaglutide against its comparator arm?

The particulars: SOUL · oral semaglutide. 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…

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
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 amara_nwachukwu 20k · 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,…

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
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
asked by leah_ferrers 12k · 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…

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 halvard_ness 69k · 15 months ago
21 votes5 answers17k views
What is the reported incidence of dizziness on cagrilintide in REDEFINE-1?

The specifics, since they change the answer: dizziness · cagrilintide · REDEFINE-1. 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…

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
amylin
amylin

Amylin and its analogues, most prominently cagrilintide, as a satiety mechanism orthogonal to incretin signalling. Includes the pharmacology of…

237 questions
asked by felix_araya 6.8k · 6 months ago
21 votes5 answers17k views
What does TRIUMPH-3 tell me about nausea at the 8 mg dose?

For reference: TRIUMPH-3 · nausea · 8 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…

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 Dr_Nadia_Farsi 104k · 15 months ago
21 votes5 answers15k views
How do I convert the REDEFINE-1 hazard ratio into an absolute risk reduction?

I have the full paper rather than the abstract, and the supplementary appendix. I would rather understand the derivation than memorise the outcome. Two people I asked…

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 vial_five 12k · 15 months ago
21 votes 5 answers15k views
Does the STEP 4 population resemble anyone asking about semaglutide here?

Conditions: STEP 4 · 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, which…

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
asked by Dr_Colm_Fitzhenry 69k · 6 months ago