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clinical-trials

Page 8 of 32 · 745 questions tagged clinical-trials.

745 questions · sorted by votes · page 8 of 32

28 votes0 answers17k views
Semaglutide or tirzepatide for a first course — what does the evidence support?

I have read the medicinal chemistry paper and the pharmacology paper, which helped and did not finish the job. I am trying to choose between two options that are…

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
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 Dr_Elias_Weiss 25k · 12 months ago
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,…

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
asked by nkem_obiora 39k · 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…

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
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 u100_marks 52k · 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…

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 second_lot 9.4k · 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…

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
clinical-trials
clinical-trials

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

745 questions
vendor-comparison
vendor-comparison

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

388 questions
asked by zainab_mustafa 21k · 18 months ago
28 votes 5 answers15k views
What does SUSTAIN-6 tell me about early satiety at the 1 mg dose?

What I have: SUSTAIN-6 · early satiety · 1 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…

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 g_paskevicius 60k · 8 months ago
28 votes0 answers14k views
What incidence of cholelithiasis did the trial programmes report?

I am asking about the pattern rather than about my own management, which is elsewhere. I can parse the result. I am less sure what it licenses me to conclude. I have…

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,…

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
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 Dr_Aoife_Brennan 20k · 19 months ago
28 votes0 answers14k views
What is the reported incidence of early satiety on semaglutide in STEP 1?

Concretely: early satiety · semaglutide · 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…

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 swirl_dont_shake 10k · 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…

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 pierce_count 24k · 13 months ago
28 votes 5 answers10k views
Is 2.4 mg weekly a defensible maintenance dose for semaglutide?

The specifics, since they change the answer: 2.4 mg · semaglutide. I would like to define my thresholds before I have a result, for obvious reasons. I want a plan…

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 anders_vestby 8.5k · 12 months ago
28 votes0 answers9.7k views
What does STEP 2 report at the 2.4 mg dose level?

Numbers first: STEP 2 · 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, which…

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 mg_per_ml 15k · 10 months ago
28 votes 5 answers9k views
What is the reported incidence of fatigue on cagrilintide in REDEFINE-1?

For reference: fatigue · cagrilintide · REDEFINE-1. I want to understand what this actually establishes, as opposed to what it is being used to imply. My concern is…

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
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 net_peptide 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…

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 unit_math 6.2k · 2.3 years ago
27 votes 4 answers50k views
What does REDEFINE-1 actually establish about cagrilintide?

The case in front of me: REDEFINE-1 · cagrilintide. 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
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
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 two_two_micron 9.3k · 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…

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 oona_kekkonen 13k · 20 months ago
27 votes3 answers39k views
What is the reported incidence of nausea on tirzepatide in SURMOUNT-1?

The case in front of me: nausea · tirzepatide · SURMOUNT-1. The figures are clear enough; the question is what they mean and what they do not. I can supply 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
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 bea_castellanos 24k · 2.1 years ago
27 votes 5 answers34k views
What is the reported incidence of headache on tirzepatide in SURPASS-2?

The case in front of me: headache · tirzepatide · SURPASS-2. 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
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
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 rae_oyelowo 17k · 2.2 years ago
27 votes 4 answers32k views
What did the placebo arm of SELECT report for injection-site erythema?

What I have: 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 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
injection-site-reaction
injection-site-reaction

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

49 questions
asked by second_lot 9.4k · 2.2 years ago
27 votes0 answers31k views
What does REDEFINE-1 tell me about vomiting at the 2.4 mg dose?

Concretely: REDEFINE-1 · vomiting · 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
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
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 t_oyelaran 79k · 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…

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 fresh_bac 9.7k · 2.0 years ago
27 votes 5 answers29k views
What does SURMOUNT-4 report at the 5 mg dose level?

Conditions: SURMOUNT-4 · 5 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 the…

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 coldbox9 41k · 19 months ago
27 votes5 answers28k views
Is there any published stability data for orforglipron at room temperature?

Concretely: orforglipron · room temperature. This has the shape of a fact but I cannot find its origin. What I found instead were three secondary sources all citing…

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 mala_venkatesh 22k · 20 months ago
27 votes 5 answers27k views
What does PIONEER-4 report at the 7 mg dose level?

The case in front of me: PIONEER-4 · 7 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
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 esther_vandeVelde 52k · 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…

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
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 pk_curve 30k · 2.3 years ago