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- || aldafermin (NGM282) / NGM Biopharma
Clinical, Journal: Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis. (Pubmed Central) - Jun 30, 2021
P2
In a phase 2 trial of patients with NASH, aldafermin reduced liver fat and produced a trend toward fibrosis improvement. ClinicalTrials.gov no: NCT02443116.
- | aldafermin (NGM282) / NGM Biopharma
Biomarker, Journal: The Commensal Microbe Veillonella as a Marker for Response to an FGF19 Analog in Nonalcoholic Steatohepatitis. (Pubmed Central) - Jun 22, 2021
P2
This study provides an integrated analysis of gut microbiome, serum bile acid metabolome, imaging and histological measurements in clinical trials testing aldafermin for NASH. Our results reveal novel biology and provide better understanding of the intricacies of microbiome-host interactions.
- |||| aldafermin (NGM282) / NGM Biopharma
Aldafermin did not achieve primary endpoint fibrosis improvement but achieved secondary endpoint NASH resolution #livertwitter 🤦🏻♂️ @AlkhouriNaim @schattenbergJ NGM Bio Reports Topline Results from 24-Week Phase 2b ALPINE 2/3 Study of Aldafermin in NASH https://t.co/O55Gog5SFd (Twitter) - May 24, 2021
- | aldafermin (NGM282) / NGM Biopharma
Journal: Potent suppression of hydrophobic bile acids by aldafermin, an FGF19 analogue, across metabolic and cholestatic liver diseases. (Pubmed Central) - Apr 27, 2021
P2
The therapeutic strategy utilising aldafermin may be broadly applicable to other chronic gastrointestinal and liver disorders. The study is registered at Clinicaltrials.govNCT02443116 and NCT02704364.
- || aldafermin (NGM282) / NGM Biopharma
Biomarker, Clinical, Journal: NGM282 Improves Liver Fibrosis and Histology in 12 Weeks in Patients with Nonalcoholic Steatohepatitis. (Pubmed Central) - Apr 15, 2021
Greater reductions in Pro-C3, ELF and cT1, but not in liver fat content, C4 or ALT, were observed in histological responders than in non-responders. In this open-label study, NGM282 improved the histological features of NASH in 12 weeks with significant reductions in NAS and fibrosis scores, accompanied by improvements in non-invasive imaging and serum markers.
- aldafermin (NGM282) / NGM Biopharma
[VIRTUAL] Atherosclerotic cardiovascular risk assessment in a 24-week, randomized, double-blind, placebo-controlled study of aldafermin (Poster area) - Apr 9, 2021 - Abstract #EASLILC2021EASL_ILC_911;
Aldafermin-associated cholesterol increase can be safely managed with a statin. At the end of treatment, an overall favorable cardiovascular risk profile was achieved in the aldafermin arm.
- aldafermin (NGM282) / NGM Biopharma
[VIRTUAL] Aldafermin reduces hydrophobic bile acids in a 24-week, randomized, double-blind, placebo-controlled, multicenter study in patients with nonalcoholic steatohepatitis (Poster area) - Apr 9, 2021 - Abstract #EASLILC2021EASL_ILC_908;
Administration of aldafermin produced significant reductions in bile acids, and the major hydrophobic bile acids in particular. The preferential reduction of the more hydrophobic, glycine-conjugated bile acids, rather than the more hydrophilic, taurine-conjugated, bile acids by aldafermin resulted in a lower G/T ratio and reduced bile acid toxicity.
- aldafermin (NGM282) / NGM Biopharma
[VIRTUAL] The FGF19 analogue aldafermin enriches the lactate-consuming, bile acid-sensitive commensal microbe Veillonella in patients with primary sclerosing cholangitis (Poster area) - Apr 9, 2021 - Abstract #EASLILC2021EASL_ILC_570;
No taxonomic differences were observed except for an increase in the rare genus Veillonella. These results echo our previous findings in non-alcoholic steatohepatitis, suggesting that Veillonella may serve as a microbiome-based marker for response to aldafermin irrespective of disease etiology.
- aldafermin (NGM282) / NGM Biopharma
[VIRTUAL] The liver fibroinflammatory marker cT1 is reduced with aldafermin therapy in a randomized, double-blind, placebo-controlled, multicenter study in patients with nonalcoholic steatohepatitis (Poster area) - Apr 9, 2021 - Abstract #EASLILC2021EASL_ILC_555;
Compared to placebo, aldafermin demonstrated signifi- cant reductions in cT1 values, consistent with its anti-inflammatory and anti-fibrotic effect on the NASH liver. Given the prognostic value of cT1 on clinical outcomes, aldafermin treatment may provide benefits to the at-risk patient population defined as having cT1 >825 ms.
- || aldafermin (NGM282) / NGM Biopharma
New P1 trial: Study of Aldafermin (NGM282) in Healthy Adult Male Japanese and Non-Japanese Subjects (clinicaltrials.gov) - Apr 1, 2021
P1, N=36, Not yet recruiting, Sponsor: NGM Biopharmaceuticals, Inc
- || aldafermin (NGM282) / NGM Biopharma
New P1 trial: Study of Aldafermin (NGM282) in Participants With Impaired Hepatic Function (clinicaltrials.gov) - Apr 1, 2021
P1, N=36, Recruiting, Sponsor: NGM Biopharmaceuticals, Inc
- Ocaliva (obeticholic acid) / Intercept, aldafermin (NGM282) / NGM Biopharma, lanifibranor (IVA337) / Inventiva
[VIRTUAL] A SYSTEMATIC REVIEW AND NETWORK META ANALYSIS FOR COMPARING PHARMACOLOGICAL INTERVENTIONS FOR THE TREATMENT OF NONALCOHOLIC STEATOHEPATITIS (DDW Virtual) - Mar 15, 2021 - Abstract #DDW2021DDW_2905;
These data have important implications for future choice of combination therapy. Therapies that have been shown to improve NASH resolution may be combined with therapies that have an anti-fibrotic effect to further boost treatment response rate in future.
- || elafibranor (GFT505) / Genfit, aldafermin (NGM282) / NGM Biopharmaceuticals, lanifibranor (IVA337) / Inventiva
https://t.co/IjE3pZWiYy #AASLD #AkeroTherapeutics #aldafermin #cirrhosis #DigitalHealth #DrugTrial #EASL #EchoSens #efruxifermin #elafibranor #Elastography #FattyLiver #FDA #FGF21 #FIB4 #FibroScan #ILC2020 #InterceptPharmaceuticals #inventiva #lanifibranor #LeanNASH #Madrigal (Twitter) - Dec 24, 2020
- || aldafermin (NGM282) / NGM Biopharma
Trial completion date, Trial primary completion date: Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study In Subjects With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis (ALPINE 2/3) (clinicaltrials.gov) - Nov 23, 2020
P2b, N=152, Active, not recruiting, Sponsor: NGM Biopharmaceuticals, Inc
Therapies that have been shown to improve NASH resolution may be combined with therapies that have an anti-fibrotic effect to further boost treatment response rate in future. Trial completion date: Dec 2020 --> Sep 2021 | Trial primary completion date: Sep 2020 --> Jun 2021
- |||| aldafermin (NGM282) / NGM Biopharmaceuticals
Clinical: Aldafermin produces fibrosis regression in NASH : Stage 3 patients with >30% MRI PDFF response had greater improvement than F2 patients https://t.co/qDtNFf9TXC (Twitter) - Nov 17, 2020
- aldafermin (NGM282) / NGM Biopharmaceuticals
[VIRTUAL] ALDAFERMIN (NGM282) PRODUCES GREATER ANTI-FIBROTIC RESPONSE IN PATIENTS WITH NONALCOHOLIC STEATOHEPATITIS AND ADVANCED FIBROSIS () - Nov 2, 2020 - Abstract #AASLD2020AASLD_2145;
Compared with placebo, aldafermin had greater effect in improving fibrosis in patients with NASH and advanced fibrosis (F3). These data support further studies of aldafermin in patients with NASH and advanced fibrosis.
- aldafermin (NGM282) / NGM Biopharmaceuticals
[VIRTUAL] LIPID MANAGEMENT IN A 24-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ALDAFERMIN (NGM282) () - Oct 11, 2020 - Abstract #AASLD2020AASLD_1678;
ROS can safely manage the cholesterol increase seen in NASH patients treated with aldafermin, producing an overall favorable lipid, lipoprotein and ASCVD profile. Given the recent revisions in society guidelines, lipid management goals based on the ASCVD risk score, rather than a particular LDL-C target value, should be implemented for future studies.
- aldafermin (NGM282) / NGM Biopharmaceuticals
[VIRTUAL] ALDAFERMIN (NGM282) IMPROVES APRI, FIB-4 AND OTHER NON-INVASIVE MEASURES IN PATIENTS WITH NONALCOHOLIC STEATOHEPATITIS () - Oct 11, 2020 - Abstract #AASLD2020AASLD_1476;
Aldafermin therapy produced improvements in several simple and inexpensive NITs of liver fibrosis, steatosis and cardiovascular risk. Among at-risk patients identified by NITs, a greater proportion of patients in the aldafermin group achieved fibrosis improvement and NASH resolution than placebo.
- aldafermin (NGM282) / NGM Biopharmaceuticals
[VIRTUAL] FINAL ANALYSIS OF A 24-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF ALDAFERMIN (NGM282) IN PATIENTS WITH NONALCOHOLIC STEATOHEPATITIS () - Oct 11, 2020 - Abstract #AASLD2020AASLD_72;
Among patients with NASH, aldafermin treatment resulted in liver fat reduction, fibrosis improvement and NASH resolution. These results are consistent with our previous 12-week studies, demonstrating durable response and accumulation of histological benefit over time.
- || aldafermin (NGM282) / NGM Biopharma
Biomarker, Clinical, P2 data, Journal: Effect of NGM282, a FGF19 analogue, in Primary Sclerosing Cholangitis: a Multicentre, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial. (Pubmed Central) - Sep 24, 2020
These results are consistent with our previous 12-week studies, demonstrating durable response and accumulation of histological benefit over time. In patients with PSC, NGM282 potently inhibited bile acid synthesis and decreased fibrosis markers, without significantly affecting ALP levels.
- || aldafermin (NGM282) / NGM Biopharma, rosuvastatin / Generic mfg.
Biomarker, Clinical, Journal: Rosuvastatin improves the FGF19 analogue NGM282-associated lipid changes in patients with nonalcoholic steatohepatitis. (Pubmed Central) - Sep 23, 2020
In this multi-center study, NGM282-associated elevation of cholesterol was effectively managed with rosuvastatin. Co-administration of rosuvastatin with NGM282 may be a reasonable strategy to optimize cardiovascular risk profile in patients with NASH.
- || aldafermin (NGM282) / NGM Biopharma
Enrollment closed: Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study In Subjects With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis (ALPINE 2/3) (clinicaltrials.gov) - Sep 23, 2020
P2b, N=152, Active, not recruiting, Sponsor: NGM Biopharmaceuticals, Inc
Co-administration of rosuvastatin with NGM282 may be a reasonable strategy to optimize cardiovascular risk profile in patients with NASH. Recruiting --> Active, not recruiting
- |||| aldafermin (NGM282) / NGM Biopharma
Trial completion, Trial completion date, Trial primary completion date: Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Sep 10, 2020
P2, N=254, Completed, Sponsor: NGM Biopharmaceuticals, Inc
Recruiting --> Active, not recruiting Active, not recruiting --> Completed | Trial completion date: Sep 2019 --> Jan 2020 | Trial primary completion date: Sep 2019 --> Dec 2019
- || aldafermin (NGM282) / NGM Biopharmaceuticals
Aldafermin shows promise for treating NASH https://t.co/t5gD9BdKAs @AmCollegeGastro @AASLDtweets (Twitter) - Sep 2, 2020
- ||||| aldafermin (NGM282) / NGM Biopharmaceuticals
Biomarker: 30-fold increase in Veillonella as a Marker for Response to a FGF19 (aldafermin): 3 mg subcutaneous dose in NASH https://t.co/svctEaDyb6 (Twitter) - Aug 26, 2020
- |||||| aldafermin (NGM282) / NGM Biopharmaceuticals
Clinical: Phase 2 study by @DrLoomba et al: effect of Aldafermin (#FGF analog) on #gut #microbiota ✳️ Pts with biopsy confirmed #NASH + #fibrosis + elevated liver fat ✳️ 12 weeks of drug vs placebo ✳️ Aldafermin cohort had ⬆️Veillonella correlating w/ ⬇️bile acids https://t.co/3Dtf6rQ1P2 (Twitter) - Aug 17, 2020
- | aldafermin (NGM282) / NGM Biopharmaceuticals
Journal: Therapeutic FGF19 promotes HDL biogenesis and transhepatic cholesterol efflux to prevent atherosclerosis. (Pubmed Central) - Jun 19, 2020
Administration of NGM282 to healthy volunteers for seven days resulted in a 26% increase in HDL-C levels compared with placebo. These findings outline a previously unrecognized role for FGF19 in the homeostatic control of cholesterol and may have direct impact on the clinical development of FGF19 analogues.
- || PF-05231023 / Pfizer, LY2405319 / Eli Lilly, aldafermin (NGM282) / NGM Biopharmaceuticals
Clinical, Journal: Fibroblast growth factors in control of lipid metabolism: from biological function to clinical application. (Pubmed Central) - Jun 10, 2020
Clinical trials with FGF-based drugs report beneficial effects in lipid and bile acid metabolism, with clinical improvements in dyslipidemia, steatosis, weight loss, and liver damage. In contrast, glucose-lowering effects, as observed in preclinical models, are currently lacking.
- aldafermin (NGM282) / NGM Biopharmaceuticals
[VIRTUAL] Aldafermin (NGM282) reduces the cross-linked pro-peptides of type III collagen PRO-C3X, a novel biomarker, in non-alcoholic steatohepatitis and primary sclerosing cholangitis patients (Poster Area) - May 30, 2020 - Abstract #EASLILCI2020EASL-ILC-I-1155;
Aldafermin significantly reduces PRO-C3X, a novel noninvasive marker of cross-linked type III collagen, across metabolic and cholestatic liver disease. Given that liver fibrosis progression and HCC growth are associated with matrix stiffness and cross-linking of collagens, these results may support an anti-tumor activity, in addition to the anti-fibrotic activity, of aldafermin in chronic liver disease.
- aldafermin (NGM282) / NGM Biopharmaceuticals
[VIRTUAL] Correlation of serum bile acids and pruritus with aldafermin (NGM282) therapy in patients with primary sclerosing cholangitis (Poster Area) - May 30, 2020 - Abstract #EASLILCI2020EASL-ILC-I-1058;
Given that liver fibrosis progression and HCC growth are associated with matrix stiffness and cross-linking of collagens, these results may support an anti-tumor activity, in addition to the anti-fibrotic activity, of aldafermin in chronic liver disease. Reductions in serum GCA and GCDCA correlated with reductions in 5D-itch score in PSC patients treated with aldafermin, suggesting that these BA species may serve as markers of pruritus response to aldafermin treatment.
- aldafermin (NGM282) / NGM Biopharmaceuticals
[VIRTUAL] The FGF19 analogue aldafermin improves non-invasive tests in patients with non-alcoholic steatohepatitis (Poster Area) - May 30, 2020 - Abstract #EASLILCI2020EASL-ILC-I-944;
Aldafermin therapy produced improvements in several simple and inexpensive NITs of liver fibrosis, steatosis and cardiovascular risk. These NITs may be useful for monitoring early treatment response to aldafermin.
- aldafermin (NGM282) / NGM Biopharmaceuticals
[VIRTUAL] Veillonella as a bile acid-sensitive bacteria and a microbiome-based biomarker for aldafermin (NGM282) in patients with non-alcoholic steatohepatitis (Poster Area) - May 30, 2020 - Abstract #EASLILCI2020EASL-ILC-I-590;
Veillonella appear to be sensitive to BAs, and especially the more hydrophobic, toxic BA species. Given that levels of lactate are elevated in patients with cirrhosis and predict organ failure and mortality, the ability of aldafermin to enrich lactate-consuming Veillonella in the gut could have a protective effect in advanced liver disease.
- aldafermin (NGM282) / NGM Biopharmaceuticals
[VIRTUAL] Positive topline results from a 24-week, randomised, double-blind, placebo-controlled, multicentre, phase 2 study of the FGF19 analogue aldafermin (NGM282) in patients with non-alcoholic steatohepatitis (Channel 1) - May 30, 2020 - Abstract #EASLILCI2020EASL-ILC-I-341;
A greater proportion of patients treated with aldafermin achieved both histological endpoints of fibrosis improvement and NASH resolution compared to PBO. Aldafermin 1mg maintained a durable response for 24 weeks with a favorable tolerability and safety profile.
- || aldafermin (NGM282) / NGM Biopharma
Trial initiation date: Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4) (clinicaltrials.gov) - Apr 29, 2020
P2b, N=150, Recruiting, Sponsor: NGM Biopharmaceuticals, Inc
Aldafermin 1mg maintained a durable response for 24 weeks with a favorable tolerability and safety profile. Initiation date: Dec 2019 --> Mar 2020
- || aldafermin (NGM282) / NGM Biopharma
Trial completion, Trial completion date: Study of Aldafermin (NGM282) in Participants With Impaired Renal Function (clinicaltrials.gov) - Apr 27, 2020
P1, N=48, Completed, Sponsor: NGM Biopharmaceuticals, Inc
Initiation date: Dec 2019 --> Mar 2020 Recruiting --> Completed | Trial completion date: Jun 2020 --> Dec 2019
- | aldafermin (NGM282) / NGM Biopharmaceuticals
Journal: NGM282, an FGF19 analogue, in primary sclerosing cholangitis: A nebulous matter. (Pubmed Central) - Mar 14, 2020
Recruiting --> Completed | Trial completion date: Jun 2020 --> Dec 2019 No abstract available
- ||| aldafermin (NGM282) / NGM Biopharma
Enrollment open: Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4) (clinicaltrials.gov) - Feb 26, 2020
P2b, N=150, Recruiting, Sponsor: NGM Biopharmaceuticals, Inc
No abstract available Not yet recruiting --> Recruiting
- aldafermin (NGM282) / NGM Biopharmaceuticals
The fgf19 analogue aldafermin improves non-invasive tests in patients with nonalcoholic steatohepatitis (Poster Area) - Feb 2, 2020 - Abstract #EASLILC2020EASL-ILC_1515;
- aldafermin (NGM282) / NGM Biopharmaceuticals
Correlation of serum bile acids and pruritus with aldafermin (ngm282) therapy in patients with primary sclerosing cholangitis (Poster Area) - Feb 2, 2020 - Abstract #EASLILC2020EASL-ILC_1357;
- aldafermin (NGM282) / NGM Biopharmaceuticals
Aldafermin (ngm282) reduces the cross-linked pro-peptides of type iii collagen pro-c3x, a novel biomarker, in nonalcoholic steatohepatitis and primary sclerosing cholangitis patients (Poster Area) - Feb 2, 2020 - Abstract #EASLILC2020EASL-ILC_1299;
- aldafermin (NGM282) / NGM Biopharmaceuticals
Veillonella as a bile acid-sensitive bacteria and a microbiome-based biomarker for aldafermin (ngm282) in patients with non-alcoholic steatohepatitis (Poster Area) - Feb 2, 2020 - Abstract #EASLILC2020EASL-ILC_811;
- | aldafermin (NGM282) / NGM Biopharmaceuticals
Journal: FGF19 Analogue as a Surgical Factor Mimetic that Contributes to Metabolic Effects Beyond Glucose Homeostasis. (Pubmed Central) - Dec 25, 2019
P2
In contrast, administration of NGM282 resulted in rapid, robust and sustained reduction in liver fat content and histology in patients with non-alcoholic steatohepatitis, faithfully replicating another key benefit of bariatric surgery. Our work identifies a strategy for replacing the surgery by an equally effective, but less invasive, treatment for non-alcoholic steatohepatitis (This trial is registered with clinicaltrials.gov, number NCT01943045).
- ||||| aldafermin (NGM282) / NGM Biopharma
New P2b trial: Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4) (clinicaltrials.gov) - Dec 24, 2019
P2b, N=150, Not yet recruiting, Sponsor: NGM Biopharmaceuticals, Inc
- || aldafermin (NGM282) / NGM Biopharma
New P1 trial: Study of Aldafermin (NGM282) in Participants With Impaired Renal Function (clinicaltrials.gov) - Nov 27, 2019
P1, N=48, Recruiting, Sponsor: NGM Biopharmaceuticals, Inc
- NGM282 / NGM Biopharmaceuticals
12 WEEKS OF NGM282 THERAPY PRODUCED SIGNIFICANT AND SUSTAINED REDUCTION IN cT1 IN PATIENTS WITH NONALCOHOLIC STEATOHEPATITIS (Hynes Convention Center, Hall B) - Sep 29, 2019 - Abstract #AASLD2019AASLD_3109;
Early and sustained cT1 reduction provides additional data attesting liver health improvement with NGM282 therapy. The use of cT1 as a non-invasive imaging tool may have value for monitoring and assessing long-term response to NGM282.
- NGM282 / NGM Biopharmaceuticals
BILE ACIDS AND LIVER FIBROSIS: SHARED ANTI-FIBROTIC EFFECTS OF NGM282, AN FGF19 ANALOGUE, IN PRIMARY SCLEROSING CHOLANGITIS AND NON-ALCOHOLIC STEATOHEPATITIS (Hynes Convention Center, Hall B) - Sep 29, 2019 - Abstract #AASLD2019AASLD_2827;
Changes in circulating levels of BAs highly correlated with changes in Pro‐C3 in patients treated with NGM282 irrespective of disease etiology. Dysregulated BA homeostasis appears to be a shared molecular mechanism, and therapeutic target, underlying fibrosis and disease progression across cholestatic and metabolic liver disease.
- NGM282 / NGM Biopharmaceuticals
NGM282, AN FGF19 ANALOGUE, REDUCES NET DEPOSITION OF COLLAGEN III IN NON-ALCOHOLIC STEATOHEPATITIS AND PRIMARY SCLEROSING CHOLANGITIS (Hynes Convention Center, Hall B) - Sep 29, 2019 - Abstract #AASLD2019AASLD_1536;
Net collagen deposition is robustly reduced in patients treated with NGM282, irrespective of NASH or PSC disease etiology. These results further support the anti-fibrotic activity of NGM282 in a spectrum of chronic liver disease.
- NGM282 / NGM Biopharmaceuticals
STABLE GUT MICROBIOME COMPOSITION AND DIVERSITY WITH NGM282 THERAPY IN PATIENTS WITH NON-ALCOHOLIC STEATOHEPATITIS (Hynes Convention Center, Hall B) - Sep 29, 2019 - Abstract #AASLD2019AASLD_968;
No taxonomic differences were observed between BL and W12 except for an increase in the low abundance genus Veillonella. This is one of the largest stool microbiome profiling report on the response to a therapeutic agent in patients with NASH.
- | aldafermin (NGM282) / NGM Biopharma
Enrollment closed: Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Aug 15, 2019
P2, N=250, Active, not recruiting, Sponsor: NGM Biopharmaceuticals, Inc
This is one of the largest stool microbiome profiling report on the response to a therapeutic agent in patients with NASH. Recruiting --> Active, not recruiting
- | NGM282 / NGM Biopharmaceuticals
Clinical, P2 data, Journal: Effects of NGM282, an FGF19 variant, on colonic transit and bowel function in functional constipation: a randomized phase 2 trial. (Pubmed Central) - Aug 8, 2019
NGM282 significantly impacts GE and colonic transit, consistent with the observed clinical symptoms. The specific mechanism of prokinetic activity requires further research.