Investigation of Tolerability, Safety, and Pharmacokinetic Properties of a Single Oral Dose of Monlunabant in Male Japanese and Caucasian Participants With Normal Body Weight

The study is testing a new study drug in healthy normal weight Japanese and Caucasian participants after a single dose. The aim of this study is to see if the new medicine is safe and how it works in the participants body. Oral monlunabant is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. The participant will either get monlunabant or placebo or a combination of both. Which treatment the participant get is decided by chance. The study will last for about 49 days in total.

Start Date09 Aug 2024

Sponsor / Collaborator

Novo Nordisk A/S

NCT05891834

/ CompletedPhase 2

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Pharmacokinetics of 3 Doses of INV-202 With an Optional Open-Label Extension in Patients With Obesity and Metabolic Syndrome

The study is designed to assess the efficacy, safety, tolerability, and transformation within the human body of INV-202 investigational drug in the treatment of adult participants with obesity and metabolic syndrome.

Start Date08 Sep 2023

Sponsor / Collaborator

Inversago Pharma, Inc.

NCT05514548

/ CompletedPhase 2

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Pharmacokinetics of Two Doses of INV-202 in Patients With Diabetic Kidney Disease

Start Date19 Oct 2022

Sponsor / Collaborator

Inversago Pharma, Inc.

[+1]

100 Clinical Results associated with Monlunabant

100 Translational Medicine associated with Monlunabant

100 Patents (Medical) associated with Monlunabant

Literatures (Medical) associated with Monlunabant

01 Jun 2026·KIDNEY INTERNATIONAL

A double-blind, randomized, placebo-controlled, phase 2 trial examined the efficacy and safety of monlunabant in adults with diabetic kidney disease

Article

Author: Poirier, Dre Lysane ; Wanner, Christoph ; Bonefeld, Karen ; Frenkel, Ofir ; Skhiladze, Eka ; Mazza, Giuseppe ; Wheeler, David C. ; Cherney, David Z.I. ; Beglarashvili, Lela ; Dwyer, Jamie P. ; Mamasakhlisi, Ana ; Dumas, Richard ; Palardy, Jean ; Svanadze, Zviad ; Lalonde, Karine ; Okropiridze, Nana ; Pachulia, Kokosha ; Furberg, Julie F. ; Kunos, George ; Crater, Glenn ; Amashukeli, Medea ; Knop, Filip K. ; Mukhashavri, Irakli

INTRODUCTION:

Diabetic kidney disease (DKD) is a significant complication of diabetes, and an unmet need remains for new therapeutic options. Here, we investigated the efficacy and safety of monlunabant, a second-generation cannabinoid receptor 1 inverse agonist, in individuals with DKD.

METHODS:

This phase 2, randomized, double-blind, placebo-controlled, multicenter study, enrolled adults with DKD. Participants were randomized (1:1:1) to receive oral tablets of monlunabant 10 mg or 25 mg, or placebo once daily for 16 weeks. The primary endpoint was the change in urine albumin-to-creatinine ratio (UACR) from baseline to week 16. Secondary endpoints included changes in urine protein-to-creatinine ratio (UPCR) and estimated glomerular filtration rate (eGFR).

RESULTS:

In total, 254 participants formed the full analysis set (85, 86, and 83 in the 10 mg, 25 mg, and placebo groups, respectively). At week 16, the estimated geometric least squares mean ratios to baseline for UACR were 0.58, 0.51, and 0.71 in the 10 mg, 25 mg, and placebo groups, respectively. Monlunabant 25 mg did not show statistically significant differences compared to placebo (estimated treatment ratio [ETR] 0.72, 95% confidence interval (0.46 to 1.14)). Therefore, formal testing was not performed for 10 mg compared to placebo (ETR 0.82 (0.53 to 1.27)). Secondary endpoints showed similar trends, with no differences in UPCR or eGFR, when compared to placebo. The most frequently reported adverse events were mild to moderate gastrointestinal disorders, driven by nausea, vomiting, and diarrhea. Participant withdrawals increased with monlunabant dose.

CONCLUSIONS:

Our study failed to establish proof of concept of monlunabant in DKD, as the effect on UACR at week 16 was not significantly different from placebo. However, greater than anticipated variability and a large placebo response affect interpretation.

TRIAL REGISTRATION:

Registered at ClinicalTrials.gov with study number NCT05514548.

01 May 2026·DIABETES OBESITY & METABOLISM

Monlunabant in adults with obesity and metabolic syndrome: Open‐label extension of a phase 2a trial

Letter

Author: Dicker, Dror ; Kunos, George ; Aronne, Louis ; Holst‐Hansen, Thomas ; Knop, Filip K. ; Frenkel, Ofir ; Paquette, Jean‐Sebastien ; Crater, Glenn ; Lalonde, Karine ; Birkhan, Oscar

01 Nov 2025·Lancet Diabetes & Endocrinology

Efficacy and safety of monlunabant in adults with obesity and metabolic syndrome: a double-blind, randomised, placebo-controlled, phase 2a trial

Article

Author: Dicker, Dror ; Kunos, George ; Holst-Hansen, Thomas ; Frenkel, Ofir ; Aronne, Louis ; Lee, Jisoo ; Lalonde, Karine ; Crater, Glenn ; Paquette, Jean-Sebastien ; Knop, Filip K

BACKGROUND:

Monlunabant, a novel cannabinoid receptor 1 (CB1R) inverse agonist, has shown encouraging weight loss efficacy and tolerability. We aimed to evaluate the efficacy and safety of monlunabant in individuals with obesity and metabolic syndrome.

METHODS:

This 16-week, randomised, double-blind, placebo-controlled, dose-ranging phase 2a trial, conducted at 25 outpatient research centres in Canada, enrolled adults with obesity and metabolic syndrome. Participants were randomly assigned (1:1:1:1) by means of an interactive response system to once-daily oral tablets of monlunabant 10 mg, 20 mg, 50 mg, or placebo. The participants, site staff, sponsor, and contract research organisation were masked to treatment allocation. The primary endpoint was mean bodyweight (kg) change from baseline at week 16 versus placebo, assessed in all eligible randomised participants, whereas the safety analysis was done in all randomised participants who received at least one dose of trial product. The estimator for the primary estimand was analysed using a mixed model for repeated measures, assuming missing data are missing at random. This trial is registered with ClinicalTrials.gov (NCT05891834) and is complete.

FINDINGS:

From Sept 8, 2023, to Jan 26, 2024, 409 individuals were screened for eligibility. In total, 243 individuals were randomly assigned to monlunabant 10 mg (n=61), monlunabant 20 mg (n=61), monlunabant 50 mg (n=60), and placebo (n=61); 242 participants received treatment, including 167 (69%) females and 75 (31%) males. 183 (76%) of 242 participants completed the trial: 50 (82%) of 61 received monlunabant 10 mg, 42 (70%) of 60 received monlunabant 20 mg, 34 (57%) of 60 received monlunabant 50 mg, and 57 (93%) of 61 received placebo. At week 16, participants receiving monlunabant showed statistically significant weight loss compared with those receiving placebo (least squares mean difference vs placebo of -6·4 kg [95% CI -8·0 to -4·9] for monlunabant 10 mg, -6·9 kg [-8·5 to -5·3] for monlunabant 20 mg, and -8·0 kg [-9·7 to -6·4] for monlunabant 50 mg). Adverse events were mostly mild to moderate gastrointestinal and psychiatric disorders and were seen in 42 (69%) of 61 participants in the monlunabant 10 mg group, 47 (78%) of 60 participants in the monlunabant 20 mg group, 55 (92%) of 60 participants in the monlunabant 50 mg group, and 42 (69%) of 61 participants in the placebo group. Withdrawals due to adverse events appeared dose-dependent, occurring in eight (13%) participants who received monlunabant 10 mg, 16 (27%) who received monlunabant 20 mg, 25 (42%) who received monlunabant 50 mg, and none who received placebo, driven by nausea, anxiety, diarrhoea, irritability, and sleep disorder. No deaths were reported.

INTERPRETATION:

Participants receiving monlunabant showed statistically significant and clinically meaningful weight loss compared with those receiving placebo for all tested doses. Only slightly greater weight loss was observed at higher doses, whereas adverse events appeared dose dependent. Further investigation is needed to assess the safety and efficacy of lower doses of monlunabant, to evaluate its potential as a medication for obesity.

FUNDING:

Inversago Pharma (a Novo Nordisk company).

News (Medical) associated with Monlunabant

05 Aug 2026

·www.fiercebiotech.com

Novo CEO accepts ‘couple of setbacks’ in R&D as CagriSema posts more mixed data

Novo Nordisk’s CEO admitted the Danish pharma has had “a couple of setbacks” in the wake of mixed data for CagriSema and its cardiovascular hopeful ziltivekimab, while stressing that the company is already on the hunt for bolt-on deals . The drugmaker’s blockbuster hopes for ziltivekimab, an antibody against the IL‑6 ligand, hit reality last week when the asset failed to demonstrate a significant reduction in major adverse cardiovascular events in a phase 3 study of patients with atherosclerotic cardiovascular disease, chronic kidney disease and inflammation. It leaves Novo pinning its hopes for the candidate on readouts next year for trials in people with heart failure or following an acute heart attack. This morning, Novo also revealed that CagriSema—a combination of the amylin analog cagrilintide with the company’s well-known GLP-1 quantity semaglutide—missed one of the endpoints of a phase 3 study in patients with Type 2 diabetes. While the head-to-head study showed that CagriSema was non-inferior to tirzepatide—marketed by Eli Lilly as Mounjaro or Zepbound for diabetes or weight loss, respectively—when it came to weight loss, the trial failed to hit its other primary endpoint of matching the blood sugar control of Lilly’s blockbuster. When looking specifically at patients who adhered to their treatment regimen, CagriSema reported an average 15.2% weight loss at 68 weeks, compared to 15.8% for those on tirzepatide. Meanwhile, the CagriSema cohort saw HbA1c reduction of 1.9 percentage points, compared to 2.2 percentage points for those on tirzepatide. The results came from the Reimagine-4 study. Novo recently announced top-line results from other studies in the Reimagine series, including the Reimagine-1 trial in patients with Type 2 diabetes—which showed a 1.8% reduction in HbA1c and average 13.8% weight loss at 40 weeks. The latest readouts come after CagriSema was previously tied to 23% weight loss after 84 weeks of treatment in a phase 3 trial of patients without diabetes, while still struggling to hold its own against Lilly’s own next-gen metabolic hopeful, the triple agonist retatrutide. Regardless of whether CagriSema can demonstrate a clear lead over the competition, Novo has already submitted the candidate for FDA approval and is hopeful of launching next year. “CagriSema remains a highly efficacious medicine,” Novo CEO Mike Doustdar told journalists on a press call this morning. “CagriSema creates a meaningful value versus the standard of care that exists today, and we will launch the product hopefully soon in [the] next year,” he added. “We will, of course, get into the details of the launch planning and the position of it as we get closer to that.” Referencing the failed ziltivekimab study, Doustdar acknowledged the company has had “a couple of setbacks recently on R&D.” “That's the nature of this industry,” he added. “Our hope, of course, is that for every one of those setbacks, we're able to demonstrate that we can progress multiple times more the innovations and bring them into the hands of the patients.” But while reaffirming that Novo has a “very robust pipeline and fantastic R&D,” Doustdar said the company “believes strongly that we need bolt-on acquisitions to complement what we are doing ourselves.” “As we're speaking to you, we have our staff looking into multiple different assets,” the CEO added. Novo also used its earnings release to confirm that the company has finally dropped monlunabant—bringing to an end the company’s unsuccessful acquisition of Inversago Pharma in a $1.1 billion deal back in 2023. The Canadian biotech had been focused on drugs that block the cannabinoid CB1 receptor. The lead asset, monlunabant, failed a phase 2 diabetic kidney disease trial last year that included reports of mild to moderate neuropsychiatric side effects. That safety data reawoke concerns about past CB1 blockers, with European authorities having withdrawn the approval of Sanofi’s own CB1 obesity drug back in 2009 after studies found it doubled the risk of psychiatric disorders. While monlunabant remained in Novo’s pipeline, the company would go on to scrap a next-generation CB1 receptor from Inversago later in 2025, although the molecule’s safety profile was not in doubt. Now, the Big Pharma has finally called time on the Inversago experiment. “The Inversago acquisition didn't pan out as we hoped for, and now we've discontinued all activities that we got from that acquisition,” Novo’s Chief Financial Officer Karsten Munk Knudsen told Fierce on this morning’s call. “We had a hypothesis around an attractive risk-benefit balance for these assets,” the CFO added. “Unfortunately, what we saw was attractive efficacy on the compound, but the safety profile was not acceptable in this class of products.”

AcquisitionClinical ResultPhase 3Phase 2

05 Aug 2026

·www.genohopebio.com

Novo Nordisk Reports Adjusted Operating Profit Of DKK 33,389 Million For Q2 2026 And Raises Full-year Outlook

Aug 05, 2026 View: 105 Leave a message Bagsværd, 4 August 2026 - Financial report for the period 1 January 2026 to 30 June 2026 Financial performance Q2 2026 reported sales increased by 3% at CER, with growth negatively impacted by a DKK 2.6 billion rebate provision reversal related to the 340B Drug Pricing Program in the US in Q2 2025. Q2 2026 adjusted sales increased by 7% at CER, driven by GLP-1 volume growth across geographies and favourable US rebate adjustments in the quarter. Q2 2026 reported operating profit decreased by 16% at CER, with growth negatively impacted by the US 340B rebate provision reversal in Q2 2025 as well as non-cash impairment charges of DKK 6.3 billion in Q2 2026 related to intangible pipeline assets, including monlunabant (DKK 4.0 billion). Q2 2026 adjusted operating profit increased by 11% at CER. Commercial highlights Wegovy® pill continues its uptake in the US, and for the week ending 17 July, total weekly prescriptions exceeded 265,000. Measured by new patient starts, the Wegovy® franchise remains the market leader among branded obesity medications in the US. Wegovy® pill was launched in the UAE in June and in the UK in July, with encouraging early uptake observed. In the coming quarters, additional Wegovy® pill launches in other select markets are planned. Wegovy® HD was launched in the US in April, and Wegovy® 7.2 mg single-dose pen in the UK in June. The roll-out of Wegovy® 7.2 mg single-dose pen across the EU is planned in the second half of 2026. Pipeline progress Within obesity, Wegovy® 7.2 mg single-dose pen received EMA approval in July based on the STEP UP data providing up to 20.7% mean weight loss. Also within obesity, Wegovy® pill received EMA approval in July based on the OASIS 4 data providing up to 16.6% mean weight loss. In cardiovascular disease, the ZEUS phase 3 trial with ziltivekimab did not meet the primary endpoint. Outlook Adjusted sales growth for 2026 is now expected to be 0% to -6% at CER and adjusted operating profit growth is now expected to be 0% to -6% at CER. The improved outlook is driven by increased expectations for GLP-1 product sales. GenoHope Biotech Ltd. A leading manufacturer of GLP-1 API Approal by FDA Welcome any Inquiry WhatsApp/Tel:+8613833133635 Email:info@genohopebio.com Send Inquiry

Drug ApprovalPhase 3Financial StatementClinical Result

05 Aug 2026

·www.biospace.com

Novo CEO sees innovation as a matter of survival amid pipeline setbacks

iStock, Blueastro Novo Nordisk CEO Maziar Mike Doustdar on a second quarter earnings call argued that failure is par for the course in the drug development business. The Danish pharma is focused on building out its pipeline to move past recent clinical roadblocks. To bounce back from a series of clinical stumbles, Novo Nordisk is leaning heavily on its innovation engine and an early-stage pipeline that could set the pharma up for long-term growth. “We stay alive—or not—based on our ability to innovate,” Doustdar told reporters during a press call early Wednesday morning to present the Danish pharma’s second quarter earnings results . He additionally alluded to “really good early signs” of innovation but declined to provide further details “because they’re early pipeline products.” Still, Doustdar appeared to be highly confident in these up-and-coming prospects. “In terms of the magnitude of the assets and areas we would like to operate in—as well as the speed of operations—we will be second to none,” he said. ezstandalone.cmd.push(function () { ezstandalone.showAds(129); }); These assertions come just days after Novo suffered a surprise late-stage blow when the IL-6 inhibitor ziltivekimab failed the Phase 3 ZEUS trial , unable to significantly lower the risk of major adverse cardiovascular events in patients with atherosclerotic cardiovascular disease, chronic kidney disease and inflammation. Ziltivekimab is a key part of Novo’s strategy of branching out to obesity-adjacent indications, looking to stand out in the cardiometabolic arena as key rival Eli Lilly cements its leadership status in the weight loss game. Immunology and inflammation Novo’s late-stage IL-6 stumble shakes inflammation space Novo Nordisk was banking on the inflammatory benefits of its investigational therapy ziltivekimab to improve cardiovascular outcomes. Last week’s Phase 3 failure dashed not just the Danish pharma’s hopes but that of other drugmakers working on the same pathway. August 3, 2026 · 2 min read · Tristan Manalac Read more In February, Novo suffered back-to-back defeats at the hands of Lilly, with two head-to-head trials pointing to the superiority of the Indiana pharma’s assets. The Phase 3 REDEFINE 4 trial, for instance, showed that Novo’s next-generation obesity candidate CagriSema elicited weaker weight loss than the FDA-approved Zepbound. Then, the late-stage ACHIEVE-3 study demonstrated that Lilly’s Foundayo led to better blood sugar control and weight reduction than Novo’s oral semaglutide. Doustdar on Wednesday’s call didn’t seem too bothered by these events. “It’s true that we have had a couple of setbacks recently on R&D,” he told reporters. “But that’s part of, and the nature of, this industry. If you don’t like setbacks and you don’t like failure, don’t get into the pharma industry. “We need to learn from the failures and reinvent ourselves again,” Doustdar continued, noting that for each of these setbacks, Novo is working to “demonstrate that we can progress multiple times more the innovations and bring them into the hands of the patients.” To this end, the CEO on the call also confirmed that Novo is on the lookout for external opportunities. “I believe strongly that we need bolt-on acquisitions to complement what we are doing ourselves,” he said. In house, the Danish giant had some clean up to do around the edges of the pipeline. The pharma revealed that it had ended work on the oral cannabinoid receptor blocker monlunabant, which was in mid-stage development for obesity . The drug came from Novo’s $1 billion acquisition of Inversago Pharma in August 2023. In September 2024, Novo revealed that the drug had spurred weight loss in a Phase 2a trial but also reported mild- to- moderate neuropsychiatric side effects . In the second quarter, Novo reported net sales of DKK 78.5 billion ($12.1 billion), representing a 3% year-on-year increase and landing ahead of analysts’ expectations. Delivering a narrow miss, however, was oral Wegovy, which made DKK 3.22 billion ($496 million) in the quarter, 2% below consensus. U.S.-listed shares of the company slid nearly 6% before the opening bell on Wednesday to $44.28. Nevertheless, Novo’s strong performance in the first half of the year, particularly within the GLP-1 franchise, emboldened the pharma to lift its full-year outlook. The Danish drugmaker now expects sales to remain flat or drop by just 6%, as opposed to prior guidance of a 4% to 12% decrease. Earnings Novo dips 6% on Wegovy pill stumble despite Q2 earnings beat Novo Nordisk’s shares fell 6% on Tuesday afternoon after its second quarter earnings report showed a slight miss for the Wegovy pill vs. consensus. August 4, 2026 · 1 min read · Annalee Armstrong Read more

AcquisitionPhase 3Clinical ResultPhase 2Financial Statement

100 Deals associated with Monlunabant

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metabolic Syndrome	Phase 2	Canada	Inversago Pharma, Inc.	08 Sep 2023
Obesity	Phase 2	Canada	Inversago Pharma, Inc.	08 Sep 2023
Diabetic Nephropathies	Phase 2	Canada	Inversago Pharma, Inc.	19 Oct 2022
Diabetic Nephropathies	Phase 2	Hungary	Inversago Pharma, Inc.	19 Oct 2022
Diabetic Nephropathies	Phase 2	Israel	Inversago Pharma, Inc.	19 Oct 2022
Diabetic Nephropathies	Phase 2	Mexico	Inversago Pharma, Inc.	19 Oct 2022
Diabetic Nephropathies	Phase 2	Serbia	Inversago Pharma, Inc.	19 Oct 2022
Glucose Intolerance	Phase 1	Canada	Inversago Pharma, Inc.	01 Mar 2022
Hypertriglyceridemia	Phase 1	Canada	Inversago Pharma, Inc.	01 Mar 2022
Obesity, Abdominal	Phase 1	Canada	Inversago Pharma, Inc.	01 Mar 2022

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05514548 (Pubmed \| Kidney Int)	Phase 2	Diabetic Nephropathies	254	Monlunabant 10 mg	supmdyqzdw(tpiqgdijqt) = ovhmhzkbnk zerulcfqit (imfveratdj ) View more	Negative	01 Jun 2026
				Monlunabant 25 mg	supmdyqzdw(tpiqgdijqt) = txhukothoz zerulcfqit (imfveratdj ) View more
NCT05514548 (NEWS) Manual	Phase 2	Diabetic Nephropathies	254	Monlunabant	hnhpvozkha(gckcrcjkdc) = The result caused the trial to miss its primary endpoint. buvaalewue (ifpjlunceg ) Not Met	Negative	05 Feb 2025
				Placebo
NCT05891834 (NEWS) Manual	Phase 2	Obesity	-	Monlunabant 10mg	sfeyszwtnl(cwtkcdmnfl) = fpggyfzctf qwoywflvpz (ifndyanwcs )	Positive	20 Sep 2024
				Placebo	sfeyszwtnl(cwtkcdmnfl) = oiruzjnwmm qwoywflvpz (ifndyanwcs )
NCT05282446 (Corporate Publications) Manual	Phase 1	Metabolic Syndrome	37	Monlunabant	ufegfkjwio(iuozlhaxgr) = oyekdyvfkz ynuwvdvccj (lcfkngunzo )	Positive	07 Mar 2024
				Placebo	ufegfkjwio(iuozlhaxgr) = vzcgbbshui ynuwvdvccj (lcfkngunzo )
NCT05282446 (ADA2023)	Phase 1	Metabolic Syndrome	37	INV-202 25 mg	wlcmoqtyyh(qmkvuktbpv) = improvements edvmlyyacz (ngdlcghhzq ) View more	-	20 Jun 2023
				Placebo

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