A Phase 2, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, and Efficacy of Increasing Optimal Doses of GSBR-1290 in Participants Living With Obesity (Body Mass Index ≥ 30 kg/m2) or Overweight (Body Mass Index ≥ 27 kg/m2) With at Least One Weight-related Comorbidity (ACCESS II)

Phase 2 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of various GSBR-1290 dose regimens compared with placebo in participants living with obesity or overweight with ≥ 1 weight-related comorbidity, in addition to diet and exercise, over a 36-week period.

Start Date20 Dec 2024

Sponsor / Collaborator

Gasherbrum Bio, Inc.

NCT06693843

/ Active, not recruitingPhase 2

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose-range Finding Study of the Efficacy and Safety of Multiple Doses of Aleniglipron (GSBR-1290) in Participants Living With Obesity (Body Mass Index ≥ 30 kg/m2) or Overweight (Body Mass Index ≥ 27 kg/m2) With at Least One Weight-related Comorbidity

This study is a randomized, double-blind, placebo-controlled, dose-range finding study of the efficacy, safety, tolerability, PK, and PD of multiple doses of aleniglipron in participants living with overweight or obesity with at least one weight-related comorbidity. Participants will be randomized to aleniglipron or placebo in a ratio of 3:1 within each Cohort receiving multiple-ascending, QD doses of aleniglipron or placebo in titration steps of 4 weeks duration for a total of 36 weeks of treatment. At the end of the study (after completing 36 weeks of treatment), participants will be offered to continue with an open-label extension (OLE) where they will receive aleniglipron for an additional 36 weeks.

Start Date17 Oct 2024

Sponsor / Collaborator

Gasherbrum Bio, Inc.

CTIS2024-512578-83-00

/ Not yet recruitingPhase 1

- GSBR-1290-07

Start Date24 Jun 2024

Sponsor / Collaborator

Structure Therapeutics, Inc.

100 Clinical Results associated with Aleniglipron

100 Translational Medicine associated with Aleniglipron

100 Patents (Medical) associated with Aleniglipron

News (Medical) associated with Aleniglipron

07 Aug 2025

·endpoints.news

Novo keeps the lead in obesity pill battle against Lilly

Eli Lilly’s injectable obesity drug Zepbound has been proven more effective than Novo Nordisk’s Wegovy. But in the battle of the pills, it appears to be the other way around. Lilly on Thursday disclosed that its oral product orforglipron had disappointed in the first of two pivotal trials, with weight loss of around 11% after 72 weeks. This trails Novo’s oral version of Wegovy, which scored weight loss of 13% in a roughly comparable trial. But the pills, both of which are GLP-1 agonists, are not the only ones in development. Roche, Viking Therapeutics and Structure Therapeutics are some of the companies also working on oral obesity candidates, and some results, though early, look very promising. Lilly and Novo will have the battleground to themselves for some time. No other pills have started Phase 3 trials in obesity, and only a handful have mid-stage data. Structure’s aleniglipron is one, having achieved a decrease in weight of 6.2% at three months in a Phase 2a trial. Aleniglipron, formerly called GSBR-1290, is now in two Phase 2b obesity studies called ACCESS and ACCESS II, assessing lower and higher doses, respectively. Patients in both studies will receive the GLP-1 for around eight months, and topline weight loss data ought to come this year, CEO Ray Stevens recently told Endpoints News. He said he hoped that the ACCESS trials might yield weight loss of about 15%. Another company with three-month Phase 2a data is Shanghai-based Regor Therapeutics. According to a presentation at the American Diabetes Association’s meeting in June, RGT-075, as its product is known, produced weight loss of 5.4%, versus 0.5% with placebo. RGT-075 is currently being evaluated in a global Phase 2b study called COMO-1, in which the pill will be given to patients with obesity or overweight with weight-related comorbidities for around eight months. Topline data are expected at the end of 2025. Novo has another iron in the fire, though it’s not an incretin. Monlunabant is an inverse agonist of the CB1 receptor that was acquired via Novo’s purchase of Inversago Pharma for up to about $1 billion in 2023. In Phase 2, patients taking a 10 mg daily dose of monlunabant for four months managed weight loss of 7.1 kg, compared with 0.7 kg for those taking the placebo. At the higher doses of 20 mg and 50 mg, Novo said there was “limited additional weight loss.” Since the average baseline weight of patients in the trial was 110.1 kg, which translates to about 243 pounds, those given 10 mg of Novo’s drug lost around 6.4% of their weight. Monlunabant remains in Novo’s pipeline, but it is unclear whether any studies are ongoing. Another large pharma with an obesity pill is Roche. CT-996 was one of a suite of obesity assets that came to the Swiss giant from the $2.7 billion acquisition of Carmot Therapeutics in 2023. It helped Phase 1 subjects lose up to 7.3% of their weight within one month. At the time this was reported last September, this was the best weight loss seen with a pill at such an early timepoint. That record did not last long. The oral form of Viking Therapeutics’ VK2735 posted a weight loss figure of 8.2% at one month in its Phase 1 trial, which read out in November. Data from a Phase 2 trial are imminent and carry high expectations. Also closely-watched is yet another Novo asset, the GLP-1 and amylin agonist amycretin. This, too, exists in both shot and pill forms. The oral version yielded weight loss of 13.1% after four months in a Phase 1 trial, although this necessitated taking two pills a day. Oral amycretin remains at the Phase 1 stage in obesity, according to Novo’s pipeline. While these early-stage assets are promising, several of these companies will be unable to bring them to market without a larger partner. And oral drugs must be dosed higher than shots, making pills more expensive to manufacture. Even so, obesity pills are expected to be immensely lucrative, and this space will evolve at a furious pace in the months and years to come.

Clinical ResultPhase 2Phase 1AcquisitionPhase 3

21 Jun 2025

·pipelinereview.com

Structure Therapeutics Announces Two Late-Breaking Poster Presentations at the American Diabetes Association 85th Scientific Sessions Including New Preclinical Data for Oral Small Molecule Amylin Agonist, ACCG-2671

SAN FRANCISCO, CA, USA I June 20, 2025 I Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, today announced two upcoming late-breaking poster presentations at the American Diabetes Association 85 th Scientific Sessions, being held from June 20-23 in Chicago, IL. “The amylin receptor is rapidly gaining clinical validation as a key target in obesity, driven by encouraging data from injectable peptide programs. We believe ACCG-2671 is well-positioned and differentiated as an oral small molecule frontrunner that is expected to enter clinical development by the end of 2025,” said Raymond Stevens, Ph.D., Founder and CEO of Structure Therapeutics. “The preclinical data being presented at ADA include the robust weight-loss effects of ACCG-2671 alone and in combination with a GLP-1 receptor agonist underscoring ACCG-2671’s potential as a future small molecule backbone treatment for obesity. In addition, we will present data demonstrating the neuroprotective effects of GLP-1 receptor agonism in preclinical models of Parkinson’s disease, reinforcing the broad role of the GLP-1 receptor across different diseases.” Presentation Details: Title: Novel Oral Small Molecule ACCG-2671: A Dual Amylin and Calcitonin Receptor Agonist Development Candidate for Obesity Therapy Poster #: 2184-LB Session: Late Breaking Poster Session Date: Sunday, June 22 Time: 12:30 p.m. – 1:30 p.m. CT Summary: ACCG-2671 demonstrated high binding affinity and balanced potency in human calcitonin receptor (CTR) and amylin receptor (AMY3R) functional assays. In diet-induced obese rats, oral administration of ACCG-2671 resulted in significant, dose-dependent body weight reductions. Combination therapy with semaglutide (both as add-on and concurrent treatment) resulted in superior weight loss compared to monotherapy. Title: Oral Small Molecule GLP-1 Receptor Agonist Demonstrates Beneficial Effects in Parkinson’s Disease–Like Model Using Humanized GLP-1R Mice Poster #: 1985-LB Session: Late Breaking Poster Session Date: Sunday, June 22 Time: 12:30 p.m. – 1:30 p.m. CT Summary: In a Parkinson’s disease mouse model, oral administration of GSBR-5595, a small molecule GLP-1 receptor agonist distinct from Structure Therapeutics’ clinical asset aleniglipron (GSBR-1290), significantly improved motor coordination and movement in both the rotarod and open field tests. Additionally, histopathological analyses revealed a significant increase in dopaminergic neurons. These findings suggest this GLP-1 receptor agonist showed neuroprotective effects by mitigating motor deficits and preserving dopaminergic neurons, highlighting a potential benefit in Parkinson’s disease. About Structure Therapeutics Structure Therapeutics is a science-driven clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic and cardiopulmonary conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, the Company has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage oral small molecule compounds designed to surpass the scalability limitations of traditional biologic and peptide therapies and be accessible to more patients around the world. For additional information, please visit www.structuretx.com . SOURCE: Structure Therapeutics

20 Dec 2024

·www.globenewswire.com

Structure Therapeutics Announces Selection of Lead Oral Small Molecule Amylin Receptor Agonist ACCG-2671 for the Treatment of Obesity

Preclinical studies with ACCG-2671 demonstrate potent target engagement, robust weight loss, favorable safety profile and PK properties supportive of once-daily dosing in humans ACCG-2671 is the most advanced oral small molecule amylin-based drug candidate, with Phase 1 study initiation expected by year end 2025 Company to host conference call today at 4:30 p.m. Eastern Time Dec. 17, 2024 -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, today announced the selection of its lead oral small molecule amylin receptor agonist, ACCG-2671. Amylin is a hormone that plays an important role in regulating glycemia and energy balance and is recognized as a promising therapeutic target for obesity and related diseases due to its effects on reducing food intake and slowing the rate of gastric emptying. ACCG-2671 was designed as an oral small molecule Dual Amylin and Calcitonin Receptor Agonist (DACRA) and is expected to enter Phase 1 clinical development by year end 2025. “We believe amylin-based therapies are an important next-generation component of the treatment landscape for obesity and related conditions due to their potential for significant weight loss, favorable tolerability profile, and lean muscle mass preservation,” said Raymond Stevens, Ph.D., Founder and Chief Executive Officer of Structure Therapeutics. “As an oral small molecule, we envision ACCG-2671 as an additional backbone therapy to improve scalability, combinability and ultimately expand patient access to amylin-based weight loss medicines. We are in a unique position to have a potentially best in class GLP-1 oral small molecule with GSBR-1290 and now the most advanced amylin oral small molecule, both intended for use as monotherapies and as backbones for fixed dose oral combinations.” In preclinical studies, ACCG-2671 demonstrated potent and balanced in vitro activities toward the key amylin receptor and the calcitonin receptor. ACCG-2671 also further demonstrated robust in vivo efficacy and a pharmacokinetic (PK) and safety profile supporting once-daily oral dosing in humans. “The preclinical data demonstrate cagrilintide-like efficacy with an oral small molecule profile, underscoring ACCG-2671’s potential as a meaningfully differentiated oral treatment for obesity and related conditions,” said Xichen Lin, Ph.D., Chief Scientific Officer of Structure Therapeutics. “Our proven GPCR structure-based drug discovery platform enabled us to rapidly advance ACCG-2671 as the lead amylin receptor agonist. We are now developing a series of amylin-based drug candidates using our technology platform to maintain our leadership in this exciting space.” Structure Therapeutics will host a conference call and webcast today, December 17, 2024 at 4:30 p.m. Eastern Time. A live webcast of the call will be available on the Investor Relations page of Structure Therapeutics’ website at https://ir.structuretx.com/events-presentations/events. To access the call by phone, participants can use the dial-in numbers listed below: US-based Investors: 1-844-826-3033 International Investors: 1-412-317-5185 Conference Call ID: 10195088 The webcast will be made available for replay on Structure Therapeutics’ website beginning approximately two hours after the live event. The replay of the webcast will be available for 90 days. Amylin is co-secreted with insulin from pancreatic beta cells in response to nutrient ingestion. Amylin has important physiological effects including reducing appetite, increasing satiety, leptin sensitivity and energy expenditure. Preclinical data from current amylin-based treatments in development suggest a potential for amylin to reduce fat mass and preserve lean mass. Two types of amylin-based treatments for the treatment of obesity are currently being developed: dual amylin and calcitonin receptor agonists (DACRAs) that target both the amylin and calcitonin receptors; and selective amylin receptor agonists (SARAs) that preferentially target the amylin receptor. Structure Therapeutics is developing a series of both DACRAs and SARAs, as both approaches have demonstrated potential as obesity and chronic weight management treatment. Structure’s lead amylin-based molecule, ACCG-2671, is a DACRA that is being evaluated for use either alone or in combination with GLP-1R agonists to treat obesity and associated diseases. ACCG-2671 is the first disclosed oral small molecule amylin-based development candidate, with Phase 1 study initiation expected by year end 2025. Structure Therapeutics is a science-driven clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic and cardiopulmonary conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, Structure Therapeutics has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage small molecule compounds designed to surpass the scalability limitations of traditional biologic and peptide therapies and be accessible to more patients around the world. For additional information, please visit www.structuretx.com. The content above comes from the network. if any infringement, please contact us to modify.

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Indication	Highest Phase	Country/Location	Organization	Date
Obesity	Phase 2	United States	Gasherbrum Bio, Inc.	17 Oct 2024
Diabetes Mellitus, Type 2	Phase 2	United States	Gasherbrum Bio, Inc.	09 Jan 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05762471 (ADA2024) Manual	Phase 1/2	Diabetes Mellitus, Type 2 \| Obesity, Metabolically Benign \| Overweight ... View more	118	GSBR-1290 + GSBR-1290 HOV	jpcpgrxiez(hahajfihyo) = There were no study discontinuations (d/c) due to adverse events (AEs). Most AEs were mild and GI-related, consistent with GLP-1RAs. Phase 2a T2DM: Two participants d/c from the study due to an AE (1 attributed to study drug: 2.8% d/c rate). For all phase 2a, AEs were mild-moderate and GI-related. avlndxdmmw (djnizrqyua ) View more	Positive	21 Jun 2024
				GSBR-1290 45 mgGSBR-1290 45 mg + GSBR-1290 45 mgGSBR-1290T2DM
NCT05762471 (Company_Website) Manual	Phase 2	Obesity	64	GSBR-1290	prmxaluprn(jotxybwelw) = As expected for the GLP1-RA drug class, leading adverse events (AEs) were gastrointestinal (GI)-related and the two most common AEs were nausea and vomiting. GI-related adverse events were generally observed early in treatment and attenuated after titration was completed. lizhykjcbr (mattajhzoq ) View more	Positive	03 Jun 2024
				Placebo
NCT05762471 (Biospace) Manual	Phase 1	-	18	GSBR-1290 (Japanese)	zlnlxxtjnq(okbrccrzvu) = bmepkrpjia vcbepklzlt (hcmpvcmqqj ) View more	Positive	18 Dec 2023
				Placebo (Japanese)	zlnlxxtjnq(okbrccrzvu) = hmgtsylmaa vcbepklzlt (hcmpvcmqqj ) View more
Biospace Manual	Phase 2	Diabetes Mellitus, Type 2 \| Obesity	94	GSBR-1290 (45 mg)	snsmhllhrd(hygzcstiot) = spnufyazrh ncottygohr (vhctpczkaw ) View more	Positive	18 Dec 2023
				GSBR-1290 (90 mg)	snsmhllhrd(hygzcstiot) = ncuefjbfzn ncottygohr (vhctpczkaw ) View more
NCT05762471 (PipelineReview) Manual	Phase 1	Overweight \| Obesity	22	Placebo	arkkzjbzjj(nhftxflnpb) = jcffiiaviu qmougbzcqu (tnvjhgozvk ) View more	Positive	29 Sep 2023
				GSBR-1290 30 mgGSBR-129030 mg	arkkzjbzjj(nhftxflnpb) = icqvvxgtfa qmougbzcqu (tnvjhgozvk ) View more

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