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clinical-trials

Page 3 of 32 · 745 questions tagged clinical-trials.

745 questions · sorted by votes · page 3 of 32

37 votes 3 answers20k views
Does hitting a plateau mean the dose needs to go up, or is that the wrong inference?

I am on tirzepatide 10 mg and have been flat for seven weeks. The reflex answer everywhere is "titrate up", and 12.5 and 15 mg exist, so the option is there. But I…

plateau
plateau

A stall in progress: distinguishing adaptive thermogenesis from measurement error from adherence drift, how long to observe before changing…

36 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…

103 questions
clinical-trials
clinical-trials

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

745 questions
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
asked by tare_weight 60k · 9 months ago
37 votes3 answers15k views
What proportion of trial participants actually stopped because of GI events, and how does that compare to real-world dropout?

I am trying to calibrate how likely it is that GI side effects end up being the reason someone stops, as opposed to being an unpleasant thing they get through. 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…

162 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
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
asked by ellis_thorne 17k · 13 months ago
36 votes5 answers69k views
What is the reported incidence of hair thinning on oral semaglutide in PIONEER-1?

Setup, so nobody has to ask: hair thinning · oral semaglutide · PIONEER-1. I have read the primary source rather than the summary, which has left me with more…

hair-loss
hair-loss

Telogen effluvium following rapid weight loss versus a drug-attributable effect: the timing signature that distinguishes them, protein and…

50 questions
clinical-trials
clinical-trials

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

745 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 esben_lykke 84k · 2.2 years ago
36 votes 5 answers54k views
What did REDEFINE 1 report against each of its component arms?

The receptor pharmacology I can follow; the in vivo translation is where I lose the thread. I would like help reading this properly rather than being told what…

cagrisema
cagrisema

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

8 questions
clinical-trials
clinical-trials

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

745 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 mz_4113 101k · 2.3 years ago
36 votes 5 answers53k views
What does the mechanism of semaglutide predict that SUSTAIN-6 did not test?

Stated plainly: semaglutide · SUSTAIN-6. The empirical answer seems settled. The explanation does not. If the honest answer is that nobody knows, I would rather hear…

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
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 greta_holzmann 23k · 20 months ago
36 votes 5 answers49k views
What did the placebo arm of ATTAIN-1 report for constipation?

What I have: ATTAIN-1 · constipation. I can parse the result. I am less sure what it licenses me to conclude. I have deliberately not looked at anyone else’s…

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 esther_vandeVelde 52k · 17 months ago
36 votes5 answers45k views
Is 1.7 mg weekly a defensible maintenance dose for dulaglutide?

What I have: 1.7 mg · dulaglutide. 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
dulaglutide
dulaglutide

A once-weekly GLP-1 receptor agonist built on an Fc fusion rather than fatty-acid acylation. Use this tag for questions about the fusion-protein…

200 questions
asked by tare_weight 60k · 16 months ago
36 votes0 answers37k views
What does SUSTAIN-6 tell me about dizziness at the 2.4 mg dose?

Conditions: SUSTAIN-6 · dizziness · 2.4 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…

clinical-trials
clinical-trials

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

745 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 pierce_count 24k · 21 months ago
36 votes5 answers36k views
What is the reported incidence of nausea on retatrutide in TRIUMPH-3?

Conditions: nausea · retatrutide · TRIUMPH-3. The figures are clear enough; the question is what they mean and what they do not. I can supply the numbers if the…

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
clinical-trials
clinical-trials

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

745 questions
retatrutide
retatrutide

An investigational GLP-1, GIP and glucagon receptor tri-agonist, studied in the TRIUMPH programme. Not approved anywhere. Use this tag for…

251 questions
asked by fib4_reader 24k · 22 months ago
36 votes 5 answers35k views
What does ESSENCE report at the 2 mg dose level?

What I have: ESSENCE · 2 mg. I can parse the result. I am less sure what it licenses me to conclude. I have deliberately not looked at anyone else’s interpretation…

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 Dr_Ingrid_Baumgartner 73k · 17 months ago
36 votes5 answers34k views
What does SOUL actually establish about oral semaglutide?

What I have: SOUL · oral semaglutide. 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…

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 bea_forsberg 11k · 20 months ago
36 votes 4 answers33k views
Does the STEP 3 population resemble anyone asking about a GLP-1 receptor agonist here?

Setup, so nobody has to ask: STEP 3 · a GLP-1 receptor agonist. 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…

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 s_kalniete 57k · 2.0 years ago
36 votes 5 answers28k views
Is there any published stability data for oral semaglutide at 30 °C?

The particulars: oral semaglutide · 30 °C. Somebody stated this to me confidently and I would like to check it before repeating it. I would accept a well-reasoned…

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
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 sinead_gaffney 28k · 16 months ago
36 votes 5 answers27k views
What does ESSENCE actually establish about semaglutide?

What I am working with: ESSENCE · 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…

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
asked by tenth_of_a_unit 57k · 2.1 years ago
36 votes5 answers20k views
Is SURMOUNT-5 a fair comparison of tirzepatide against its comparator arm?

Conditions: SURMOUNT-5 · 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…

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 orla_sheridan 18k · 18 months ago
35 votes 5 answers57k views
How comparable are a GLP-1 receptor agonist and cagrilintide on the evidence available?

What I have: a GLP-1 receptor agonist · cagrilintide. I have used one of these for a while and I am considering switching, which requires a reason. What I care about…

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
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 elke_brunner 17k · 2.2 years ago
35 votes 5 answers50k views
How do I convert the SURMOUNT-5 hazard ratio into an absolute risk reduction?

I have three data points across nine months, which I hope is enough to see a trend. I would like the arithmetic checked rather than the conclusion asserted. I have…

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 area_percent 9.9k · 22 months ago
35 votes 5 answers47k views
How comparable are cagrilintide and liraglutide on the evidence available?

Stated plainly: cagrilintide · liraglutide. I have used one of these for a while and I am considering switching, which requires a reason. What I care about 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
amylin
amylin

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

237 questions
liraglutide
liraglutide

A once-daily GLP-1 receptor agonist and the compound that established the class. Still relevant for its shorter half-life, its paediatric and…

235 questions
asked by lucia_marchetti 19k · 21 months ago
35 votes 5 answers44k views
What did the placebo arm of STEP 5 report for early satiety?

The specifics, since they change the answer: STEP 5 · early satiety. 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…

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 pip_okonjo 13k · 14 months ago
35 votes5 answers41k views
Does the SURMOUNT-OSA population resemble anyone asking about tirzepatide here?

Concretely: SURMOUNT-OSA · tirzepatide. 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
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
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 bufferline42 30k · 23 months ago
35 votes5 answers38k views
What does the mechanism of a GLP-1 receptor agonist predict that ESSENCE did not test?

Details up front: a GLP-1 receptor agonist · ESSENCE. I suspect the usual explanation for this is wrong, or at least incomplete. I am aware this may have a boring…

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
asked by juan_esquivel 14k · 23 months ago
35 votes 5 answers37k views
Is 36 mg weekly a defensible maintenance dose for orforglipron?

Numbers first: 36 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 t_oyelaran 79k · 2.4 years ago
35 votes 5 answers34k views
What does TRIUMPH-1 tell me about dizziness at the 8 mg dose?

Setup, so nobody has to ask: TRIUMPH-1 · dizziness · 8 mg. I would like help reading this properly rather than being told what conclusion to reach. I have the full…

clinical-trials
clinical-trials

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

745 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 threadlock7 19k · 19 months ago
35 votes 3 answers32k views
What does PIONEER-4 report at the 14 mg dose level?

For reference: PIONEER-4 · 14 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…

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 valentina_rossi 9.7k · 18 months ago