Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms
9 Meters Biopharma, Inc.307 participants29 May 2019 to 21 Jul 2022
Celiac Disease
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated
Comparing 2 peptides · Data version 308560
Swipe sideways to see every peptide.
| Peptide | Synthetic analog Larazotide | Synthetic analog Linaclotide | |
|---|---|---|---|
| Identity | |||
| Kind | Synthetic analog | Synthetic analog | |
| Area | Gut and digestion | Gut and digestion | |
| Evidence | |||
| Amount of evidence | 91 | 389 | |
| Evidence level | Has results from studies in people | Has results from studies in people | |
| Safety | |||
| Safety results | 8 (7 in people) | 57 (57 in people) | |
| Status | |||
| Approval | Not recorded | ||
| Sport (WADA) | |||
| Registered trials | 10 | 52 · 7 active8 more mention it but do not test it | |
Shared outcomes
From the regulatory data of each peptide.
The FDA label for Linzess says: “IBS-C in adults and pediatric patients aged 7 years and older”
Outcome groups with study results for at least two of these peptides. Counts include only results from studies that gave the peptide. Bar length is the number of results, on one scale. The bars show how much was studied, not how large an effect was. A peptide with more studies can look stronger here without being stronger. For results, see the randomized results above.
| Outcome group | Larazotide | Linaclotide |
|---|---|---|
| Gastrointestinal protectionGastrointestinal | 441213181 |
PepBank is a research reference. Talk to a doctor before you use any peptide.
362187
| Gastrointestinal functionWhole body | 11 | 3535 |
|---|
| PainNervous system and cognition | 11 | 4321202 |
|---|
| Adverse eventsWhole body | 77 | 2020 |
|---|
| Receptor activity and mechanismWhole body | 1248 | 3061014 |
|---|
| Exercise and physical functionWhole body | 22 | 1010 |
|---|
| Overall treatment effectWhole body | 11 | 22 |
|---|
| Inflammation markersImmune and inflammation | 211 | 321 |
|---|
| MortalityWhole body | 11 | 11 |
|---|
For each outcome that two or more peptides have results for: the best result of a single randomized trial, on the same measure (the same kind of number, the same unit). When a trial has several dose arms, the cell shows the highest dose arm. The trials differ in people, length and dose, so a gap between two cells is not proof that one peptide works better.
No outcome has a randomized-trial result on the same measure for two or more of these peptides yet.
The other peptides have no randomized result on the same measure, so these results cannot be set side by side.
| Outcome | Larazotide | Linaclotide |
|---|---|---|
| Gastrointestinal protectionGastrointestinalCompared as: value in the arm that got the peptide, in % | No comparable result 11 randomized-trial results measure it in another way or another unit. | 15.7% Primary response · linaclotide 145 μg Placebo: 7.6% Dose studied: 145 μg once daily12 weeksn not reported2015 |
| PainNervous system and cognitionCompared as: difference from placebo, in p-value | No comparable result 1 randomized-trial result measure it in another way or another unit. | 0.1028 p-value P value, abdominal discomfort versus placebo Dose studied: 72 μg once daily12 weeksn not reported2018 |
| Receptor activity and mechanismGastrointestinalCompared as: value in the arm that got the peptide, in milliseconds | No randomized trial result 12 results from other study designs. | 19 milliseconds P1 latency change from baseline Placebo: 3 milliseconds Dose studied: 290 µg10 weeksn = 392020 |
| Gastrointestinal functionGastrointestinalCompared as: value in the arm that got the peptide, in % | No randomized trial result 1 result from other study designs. | 21.2% Patients reaching primary CSBM end point · linaclotide 145 μg once daily, Trial 303 Placebo, Trial 303: 3.3% Dose studied: 145 μg once daily12 weeksn not reported2011 |
| Adverse eventsWhole bodyCompared as: value in the arm that got the peptide, in % | No comparable result 6 randomized-trial results measure it in another way or another unit. | 5.7% Discontinuation due to diarrhea · linaclotide 290 µg Placebo: 1.3% Dose studied: 290 µg once daily8 weeksn = 1672020 |
No comparable result
11 randomized-trial results measure it in another way or another unit.
15.7%
Primary response · linaclotide 145 μg
Placebo: 7.6%
Dose studied: 145 μg once daily12 weeksn not reported2015
No comparable result
1 randomized-trial result measure it in another way or another unit.
0.1028 p-value
P value, abdominal discomfort versus placebo
Dose studied: 72 μg once daily12 weeksn not reported2018
No randomized trial result
12 results from other study designs.
19 milliseconds
P1 latency change from baseline
Placebo: 3 milliseconds
Dose studied: 290 µg10 weeksn = 392020
No randomized trial result
1 result from other study designs.
21.2%
Patients reaching primary CSBM end point · linaclotide 145 μg once daily, Trial 303
Placebo, Trial 303: 3.3%
Dose studied: 145 μg once daily12 weeksn not reported2011
No comparable result
6 randomized-trial results measure it in another way or another unit.
5.7%
Discontinuation due to diarrhea · linaclotide 290 µg
Placebo: 1.3%
Dose studied: 290 µg once daily8 weeksn = 1672020
Registered trials, ranked by phase (late phases first), then posted results and enrollment. Status is the registry status. Study results come from published studies. Results posted at ClinicalTrials.gov are shown on each trial page.
Top 3 of 10 trials, ranked by phase, then posted results and enrollment: 2 completed · 1 stopped early · source ClinicalTrials.gov (opens in a new tab)
9 Meters Biopharma, Inc.307 participants29 May 2019 to 21 Jul 2022
Celiac Disease
9 Meters Biopharma, Inc.342 participants7 Nov 2011 to 20 Aug 2013
Celiac Disease
9 Meters Biopharma, Inc.171 participantsAug 2007 to Mar 2009
Celiac Disease
Top 3 of 52 trials, ranked by phase, then posted results and enrollment: 3 completed · 3 with posted results · source ClinicalTrials.gov (opens in a new tab)
Ironwood Pharmaceuticals, Inc.1,743 participantsSept 2008 to Mar 2012
Irritable Bowel Syndrome With Constipation · Chronic Constipation
AstraZeneca1,722 participantsJul 2013 to May 2015
Irritable Bowel Syndrome With Constipation (IBS-C)
Forest Laboratories1,559 participants31 Oct 2008 to 31 Jan 2012
Chronic Constipation · Irritable Bowel Syndrome With Constipation
8 more mention it but do not test it. They only measure it or name it in their text.