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clinical-trials

Page 6 of 32 · 745 questions tagged clinical-trials.

745 questions · sorted by votes · page 6 of 32

31 votes 5 answers15k views
Does albuminuria regression translate into hard renal endpoints?

My laboratory results are from the same laboratory each time, drawn fasting, which I gather matters. I want to know whether there is evidence behind this or only…

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.

9 questions
kidney-function
kidney-function

eGFR, creatinine, cystatin C and albuminuria: the acute haemodynamic dip that is not injury, the renal outcome data from the FLOW programme, and…

141 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 tadhg_o_riordan 7.7k · 16 months ago
31 votes4 answers14k views
What did SURMOUNT-3 do with participants who could not tolerate a step?

I have been on a stable schedule for eleven weeks, so this is not a first-week question. I can parse the result. I am less sure what it licenses me to conclude. I…

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 elke_brunner 17k · 13 months ago
30 votes 5 answers55k views
What is the reported incidence of reflux on semaglutide in STEP 3?

What I have: reflux · semaglutide · STEP 3. I can parse the result. I am less sure what it licenses me to conclude. I have deliberately not looked at anyone else’s…

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
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
asked by ivo_paunovic 16k · 22 months ago
30 votes 5 answers54k views
How comparable are oral semaglutide and semaglutide on the evidence available?

What I am working with: oral semaglutide · semaglutide. The comparison I want does not seem to exist anywhere in a form I can evaluate. I have read the arguments for…

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 fresh_bac 9.7k · 2.1 years ago
30 votes 5 answers45k views
What did the placebo arm of STEP 3 report for hair thinning?

For reference: STEP 3 · hair thinning. I want to understand what this actually establishes, as opposed to what it is being used to imply. My concern is that 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
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
asked by zainab_mustafa 21k · 2.0 years ago
30 votes5 answers36k views
What does the mechanism of semaglutide predict that STEP 1 did not test?

Conditions: semaglutide · STEP 1. I want to know whether this is a real physical effect or an artefact of how it is measured. What prompted the question is an…

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 seven_day_half 31k · 15 months ago
30 votes 5 answers36k views
Is 15 mg weekly a defensible maintenance dose for ecnoglutide?

For reference: 15 mg · ecnoglutide. 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…

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
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…

223 questions
asked by sasha_ferreira 9.4k · 23 months ago
30 votes5 answers27k views
What does PIONEER-1 tell me about nausea at the 14 mg dose?

The particulars: PIONEER-1 · nausea · 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…

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 label_claim 30k · 2.2 years ago
30 votes 5 answers23k views
What is the reported incidence of fatigue on semaglutide in STEP 5?

For reference: fatigue · semaglutide · STEP 5. I have the document in front of me and I can read the numbers. What I cannot do is interpret them. I am reasonably…

fatigue
fatigue

Tiredness on treatment: how much is energy deficit, how much is dehydration or electrolyte drift, how much is genuinely drug-attributable, and…

78 questions
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
asked by ahmed_zerouali 15k · 12 months ago
30 votes0 answers20k views
Is 1 mg weekly a defensible maintenance dose for semaglutide?

For reference: 1 mg · semaglutide. I would like to define my thresholds before I have a result, for obvious reasons. I want a plan with explicit stopping rules, not…

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
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 coldbox9 41k · 12 months ago
30 votes5 answers20k views
What did the placebo arm of SURMOUNT-3 report for reflux?

The case in front of me: SURMOUNT-3 · reflux. The figures are clear enough; the question is what they mean and what they do not. I can supply the numbers if the…

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 aine_mulcahy 28k · 13 months ago
30 votes 5 answers17k views
What did the placebo arm of REDEFINE-1 report for reflux?

What I am working with: REDEFINE-1 · reflux. I have read the primary source rather than the summary, which has left me with more questions. I understand the headline.…

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 swirl_dont_shake 10k · 10 months ago
30 votes 5 answers16k views
What AHI reduction did SURMOUNT-OSA report, and from which baseline?

I have three data points across nine months, which I hope is enough to see a trend. I have the document in front of me and I can read the numbers. What I cannot do is…

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
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 tobias_reint 20k · 11 months ago
30 votes0 answers16k views
What is the reported incidence of hair thinning on tirzepatide in SURMOUNT-3?

The case in front of me: hair thinning · tirzepatide · SURMOUNT-3. The figures are clear enough; the question is what they mean and what they do not. I can supply the…

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
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 rune_thoresen 16k · 11 months ago
30 votes 3 answers13k views
What does adding glucagon receptor agonism actually buy, and what does it cost you?

I am trying to understand the logic of putting glucagon receptor agonism into a weight-loss molecule, because on the face of it it sounds like a mistake. Glucagon…

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
survodutide
survodutide

A GLP-1 and glucagon receptor dual agonist with a substantial published MASH dataset. Use this tag for its hepatic endpoints, its dose ladder, and…

225 questions
glucagon-receptor
glucagon-receptor

Glucagon receptor agonism as a deliberate component of dual and tri-agonists: what it adds in energy expenditure and hepatic fat mobilisation, and…

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
asked by s_bhattacharya 31k · 20 months ago
30 votes5 answers12k views
What does FLOW tell me about headache at the 2 mg dose?

What I have: FLOW · headache · 2 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
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 triple_agonist_q 57k · 12 months ago
30 votes 4 answers12k views
What does REDEFINE-1 tell me about injection-site erythema at the 2.4 mg dose?

The case in front of me: REDEFINE-1 · injection-site erythema · 2.4 mg. The figures are clear enough; the question is what they mean and what they do not. I can…

clinical-trials
clinical-trials

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

745 questions
injection-site-reaction
injection-site-reaction

Local reactions: erythema, induration, pruritus and nodules. Their relationship to injection depth, diluent composition, benzyl alcohol…

49 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 · 14 months ago
30 votes 3 answers11k views
What did the placebo arm of SURMOUNT-1 report for vomiting?

Concretely: SURMOUNT-1 · vomiting. The figures are clear enough; the question is what they mean and what they do not. I can supply the numbers if the specifics change…

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 micron22 22k · 11 months ago
30 votes0 answers11k views
What does STEP 1 tell me about dizziness at the 2 mg dose?

Stated plainly: STEP 1 · dizziness · 2 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…

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 bridget_nyathi 12k · 11 months ago
29 votes 5 answers57k views
What does STEP 2 tell me about injection-site erythema at the 2 mg dose?

The case in front of me: STEP 2 · injection-site erythema · 2 mg. The figures are clear enough; the question is what they mean and what they do not. I can supply the…

clinical-trials
clinical-trials

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

745 questions
injection-site-reaction
injection-site-reaction

Local reactions: erythema, induration, pruritus and nodules. Their relationship to injection depth, diluent composition, benzyl alcohol…

49 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 tare_and_weigh 12k · 2.1 years ago
29 votes 5 answers40k views
What does SURMOUNT-1 tell me about reflux at the 10 mg dose?

Stated plainly: SURMOUNT-1 · reflux · 10 mg. I have read the primary source rather than the summary, which has left me with more questions. I understand the headline.…

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
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 one_ml_bac 18k · 21 months ago
29 votes 3 answers36k views
Is there any published stability data for oral semaglutide at minus 80 °C?

The particulars: oral semaglutide · minus 80 °C. I would like to know whether this claim survives contact with evidence. If the answer is "nobody has tested that", I…

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 bac_or_bust 33k · 15 months ago
29 votes 5 answers28k views
How do I convert the SURMOUNT-2 hazard ratio into an absolute risk reduction?

The clinician who ordered the panel was not concerned; I would still like to understand it. The units are where I keep going wrong, so please be explicit about them.…

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 seven_day_half 31k · 20 months ago
29 votes0 answers27k views
What did the placebo arm of SURMOUNT-5 report for dizziness?

Conditions: SURMOUNT-5 · dizziness. 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
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
asked by micron22 22k · 2.3 years ago