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clinical-trials

Page 10 of 39 · 913 questions tagged clinical-trials.

913 questions · sorted by votes · page 10 of 39

28 votes5 answers16k views
Is there any published stability data for a GLP-1 receptor agonist at 40 °C?

Details up front: a GLP-1 receptor agonist · 40 °C. I am asking for verification rather than opinion, ideally with something I can read myself. It is possible the…

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 nkem_obiora 46k · 7 months ago
28 votes 5 answers16k views
What did the placebo arms report for nausea, and why does that matter?

I have three data points across nine months, which I hope is enough to see a trend. This is presented as though it settles something, and I am not convinced it does.…

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
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 u100_marks 38k · 10 months ago
28 votes 5 answers16k views
What did SURPASS-3 do with participants who could not tolerate a step?

I am asking about the protocol logic rather than about my own case specifically. This is presented as though it settles something, and I am not convinced it does. 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…

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 second_lot 11k · 23 months ago
28 votes 3 answers16k views
Is there an honest apples-to-apples comparison of the STEP and SURMOUNT headline results?

Every comparison I find is either a marketing graphic putting -20.9% next to -14.9% with no caveats, or a methodology piece telling me cross-trial comparison is…

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
clinical-trials
clinical-trials

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

913 questions
vendor-comparison
vendor-comparison

Side-by-side comparison of suppliers on measurable axes - independently confirmed purity and content, lead time, cold-chain handling,…

351 questions
mazdutide
mazdutide

A GLP-1 and glucagon receptor dual agonist developed primarily in China, with a distinct dose range and a fast-moving publication record.…

14 questions
asked by zainab_mustafa 16k · 18 months ago
28 votes 5 answers15k views
What does SUSTAIN-6 tell me about early satiety at the 50 mg dose?

What I have: SUSTAIN-6 · early satiety · 50 mg. I can parse the result. I am less sure what it licenses me to conclude. I have deliberately not looked at anyone…

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 g_paskevicius 44k · 8 months ago
28 votes5 answers15k views
What does SURMOUNT-OSA tell me about hair thinning at the 4 mg dose?

Details up front: SURMOUNT-OSA · hair thinning · 4 mg. I can parse the result. I am less sure what it licenses me to conclude. I have deliberately not looked at…

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 Dr_Lena_Ostrowska 42k · 7 months ago
28 votes0 answers14k views
What is the reported incidence of early satiety on liraglutide in STEP 1?

Concretely: early satiety · liraglutide · STEP 1. I would like to know the limits of what can be inferred from this. What I am trying to avoid is over-reading a…

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 swirl_dont_shake 19k · 13 months ago
28 votes 5 answers13k views
What did SURMOUNT-OSA 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. I would like to know the limits of what can be inferred from this. What 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…

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 pierce_count 15k · 13 months ago
28 votes 5 answers10k views
Is 4 mg weekly a defensible maintenance dose for semaglutide?

The specifics, since they change the answer: 4 mg · semaglutide. I would like to define my thresholds before I have a result, for obvious reasons. I want a plan with…

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 anders_vestby 17k · 12 months ago
28 votes0 answers9.7k views
What does STEP 2 report at the 2.5 mg dose level?

Numbers first: STEP 2 · 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, which…

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 mg_per_ml 12k · 10 months ago
27 votes 5 answers60k views
How do I convert the SURMOUNT-OSA hazard ratio into an absolute risk reduction?

This is a question about interpretation, not about whether to act — I will take action questions elsewhere. I want the working, not the result — I need to be able to…

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
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 unit_math 13k · 2.3 years ago
27 votes 4 answers50k views
What does REDEFINE-1 actually establish about tirzepatide?

The case in front of me: REDEFINE-1 · tirzepatide. 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…

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
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…

14 questions
asked by two_two_micron 15k · 2.2 years ago
27 votes 5 answers45k views
What did the placebo arm of ATTAIN-1 report for dizziness?

Conditions: ATTAIN-1 · 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 change…

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 oona_kekkonen 16k · 20 months ago
27 votes3 answers39k views
What is the reported incidence of nausea on liraglutide in SURMOUNT-1?

The case in front of me: nausea · liraglutide · SURMOUNT-1. The figures are clear enough; the question is what they mean and what they do not. I can supply 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 bea_castellanos 47k · 2.1 years ago
27 votes0 answers36k views
What does the mechanism of retatrutide predict that SURMOUNT-4 did not test?

Stated plainly: retatrutide · SURMOUNT-4. 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 cake_collapsed 13k · 2.0 years ago
27 votes 5 answers34k views
What is the reported incidence of headache on oral semaglutide in SURPASS-2?

The case in front of me: headache · oral semaglutide · SURPASS-2. The figures are clear enough; the question is what they mean and what they do not. I can supply 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 rae_oyelowo 21k · 2.2 years ago
27 votes 4 answers32k views
What did the placebo arm of SELECT report for injection-site erythema?

The case in front of me: SELECT · injection-site erythema. I would like to know the limits of what can be inferred from this. What I am trying to avoid 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
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 · 2.2 years ago
27 votes0 answers31k views
What does REDEFINE-1 tell me about vomiting at the 5 mg dose?

Concretely: REDEFINE-1 · vomiting · 5 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…

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 t_oyelaran 41k · 2.3 years ago
27 votes0 answers29k views
What did REDEFINE-1 do with participants who could not tolerate a step?

The label documentation for the agent in question is ambiguous on exactly this point. The figures are clear enough; the question is what they mean and what they do…

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 fresh_bac 13k · 2.0 years ago
27 votes 5 answers29k views
What does SURMOUNT-4 report at the 30 mg dose level?

Conditions: SURMOUNT-4 · 30 mg. 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…

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 coldbox9 13k · 19 months ago
27 votes 5 answers27k views
What does PIONEER-4 report at the 2 mg dose level?

The case in front of me: PIONEER-4 · 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…

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
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…

14 questions
asked by esther_vandeVelde 49k · 2.3 years ago
27 votes0 answers27k views
What is the reported incidence of nausea on tirzepatide in SURMOUNT-2?

The case in front of me: nausea · tirzepatide · SURMOUNT-2. The figures are clear enough; the question is what they mean and what they do not. I can supply 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 pk_curve 12k · 2.3 years ago
27 votes 5 answers27k views
What does SUSTAIN-6 actually establish about oral semaglutide?

The case in front of me: SUSTAIN-6 · oral semaglutide. The figures are clear enough; the question is what they mean and what they do not. I can supply the numbers if…

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
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…

14 questions
asked by cake_collapsed 13k · 9 months ago
27 votes 5 answers26k views
What did STEP 3 do with participants who could not tolerate a step?

This came up because two published schedules for the same agent differ. I would like help reading this properly rather than being told what conclusion to reach. 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…

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 Dr_Malik_Osei 37k · 10 months ago