UBT251 / United Laboratories, Novo Nordisk - LARVOL DELTA

Phase III Study of UBT251 Injection in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin ± Sulfonylurea/SGLT2 Inhibitor Therapy (UNIGUIDE-2) (clinicaltrials.gov) - P3 | N=956 | Recruiting | Sponsor: The United Bio-Technology (Hengqin) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Phase III Study of UBT251 Injection in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Diet and Exercise Alone（UNIGUIDE-1） (clinicaltrials.gov) - P3 | N=360 | Recruiting | Sponsor: The United Bio-Technology (Hengqin) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

United Laboratories Begins Phase III Dosing of Obesity Drug UBT251 in China (The Globe and Mail) - "The study will enroll 600 participants with obesity or overweight plus at least one weight-related comorbidity, measuring percentage weight change and the proportion achieving at least 5 percent weight loss after 52 weeks of treatment."

Trial status • Obesity

UNISHAPE-OSA-2: UBT251 Injection Phase Ⅲ Study (OSA-PAP) (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: The United Bio-Technology (Hengqin) Co., Ltd.

New P3 trial • Genetic Disorders • Obesity • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Safety, Pharmacokinetics and Pharmacodynamics of the GLP-1/GIP/GCG Receptor Agonist UBT251 Injection: A Randomized, Placebo-Controlled Phase 1a/1b Study. (PubMed, Diabetes Obes Metab) - P1 | "UBT251 demonstrated an acceptable safety profile and predictable pharmacokinetic properties, accompanied by substantial weight reduction and meaningful metabolic improvements. These findings strongly support the continued clinical development of UBT251 as a potential therapeutic option for obesity and type 2 diabetes."

Clinical • First-in-human • Journal • P1 data • PK/PD data • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus • GCG

UBT251, a triple hormone receptor agonist in adults with overweight or obesity: a multicentre, double-blind, placebo-controlled, randomised, Phase 2 trial (EASD 2026) - P2 | "In adults with overweight or obesity, UBT251 showed significant and dose-dependent weight loss up to 19.7%, and was generally well-tolerated."

Clinical • P2 data • Metabolic Disorders • Obesity • GCG

UBT251, a triple GLP-1, GIP, and GCG receptor agonist in patients with type 2 diabetes: a multicentre, double-blind, placebo- and active-controlled, randomised, Phase II trial (EASD 2026) - P2 | "Materials and This phase II trial enrolled Chinese patients aged 18-75 years with T2D, HbA1c of 7.0-10.5% and BMI of 23.0- 40.0 kg/m 2 , who were managed with lifestyle intervention or stable-dose metformin for at least 3 months before screening. Eligible patients were randomly assigned (2:1:1:2:2:2) to receive once-weekly subcutaneous UBT251 (2.0 mg, 4.0 mg [initial dose {ID}, 0.5 mg], 4.0 mg [ID, 1.0 mg] and 6.0 mg), semaglutide (1.0 mg) or placebo for 24 weeks... UBT251 demonstrated promising and clinically relevant improvements in glycaemic control and weight reduction in patients with T2D, with an acceptable safety profile."

Clinical • P2 data • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus • GCG

A Research Study Looking Into How UBT251 Works With Birth Control Tablets and Emptying of the Stomach in Women With Excess Body Weight Not Able to Become Pregnant (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Long-acting Reversible Contraceptives • Obesity

Phase I Drug-Drug Interaction Study of UBT251 Injection in Participants With Overweight or Obesity (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: The United Bio-Technology (Hengqin) Co., Ltd.

New P1 trial • Genetic Disorders • Obesity

A Research Study on How UBT251 Affects Levels of Midazolam, Caffeine and Warfarin in the Blood of Participants With Excess Body Weight (clinicaltrials.gov) - P1 | N=44 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

UNISHAPE-OSA-1: Phase III Trial of UBT251 in Moderate-to-Severe OSA With Obesity: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study. (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: The United Bio-Technology (Hengqin) Co., Ltd.

New P3 trial • Genetic Disorders • Obesity • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of UBT251 in Overweight/Obese Patients (ChiCTR) - P1 | N=60 | Completed | Sponsor: The Third Xiangya Hospital Central South University; The Third Xiangya Hospital Central South University

New P1 trial • Obesity

A Research Study on How UBT251 Affects Levels of Midazolam, Caffeine and Warfarin in the Blood of Participants With Excess Body Weight (clinicaltrials.gov) - P1 | N=44 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New P1 trial • Genetic Disorders • Obesity

A Research Study Looking Into How UBT251 Works With Birth Control Tablets and Emptying of the Stomach in Women With Excess Body Weight Not Able to Become Pregnant (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New P1 trial • Genetic Disorders • Long-acting Reversible Contraceptives • Obesity

A Research Study Comparing How Well Different Doses of the Medicine UBT251 Lower Blood Sugar in People With Type 2 Diabetes (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • CST3

A Research Study Comparing How Well Different Doses of the Medicine UBT251 Lower Blood Sugar in People With Type 2 Diabetes (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • CST3

Phase III Study of UBT251 Injection in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Diet and Exercise Alone（UNIGUIDE-1） (clinicaltrials.gov) - P3 | N=360 | Not yet recruiting | Sponsor: The United Bio-Technology (Hengqin) Co., Ltd.

New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Phase III Study of UBT251 Injection in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin ± Sulfonylurea/SGLT2 Inhibitor Therapy (UNIGUIDE-2) (clinicaltrials.gov) - P3 | N=956 | Not yet recruiting | Sponsor: The United Bio-Technology (Hengqin) Co., Ltd.

New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

UBT251, a Triple Hormone Receptor Agonist in Adults with Overweight or Obesity: A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Phase 2 Trial (ADA 2026) - P2 | "In adults with overweight or obesity, UBT251 showed significant and dose-dependent %WL up to 19.7%, and was generally well-tolerated."

Clinical • Late-breaking abstract • P2 data • Metabolic Disorders • Obesity

UBT251 Injection Phase Ⅲ Study (Overweight or Obesity) (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: The United Bio-Technology (Hengqin) Co., Ltd.

New P3 trial • Genetic Disorders • Obesity

UBT251 Injection Phase II (Type 2 Diabetes Mellitus) Study (clinicaltrials.gov) - P2 | N=211 | Completed | Sponsor: The United Bio-Technology (Hengqin) Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

UBT251 Injection Phase II Study (Overweight or Obesity) (clinicaltrials.gov) - P2 | N=205 | Completed | Sponsor: The United Bio-Technology (Hengqin) Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

Novo Nordisk recently initiated a global phase 1b/2a trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of different doses of UBT251 for up to 28 weeks in around 330 people living with overweight or obesity. (GlobeNewswire) - "Topline data from that trial is expected in 2027. Novo Nordisk also expects to initiate a phase 2 trial with UBT251 in people with type 2 diabetes in the second half of 2026."

New P2 trial • P1/2 data • Obesity • Type 2 Diabetes Mellitus

Novo Nordisk: Triple agonist UBT251 delivers up to 19.7% mean weight loss after 24 weeks in phase 2 trial in China (GlobeNewswire) - "From a baseline mean body weight of 92.2 kg, the highest mean weight loss observed for people treated with UBT251 was 19.7% (-17.5 kg) compared to 2.0% (-1.6kg) in the placebo group after 24 weeks of treatment...Moreover, all dose groups of UBT251 showed statistically significant improvements relative to placebo on key secondary endpoints, including waist circumference, blood glucose, blood pressure and lipids...'We look forward to reporting data from a global trial with UBT251 conducted by Novo Nordisk next year.'...United Biotechnology will present detailed data from the Chinese phase 2 trial at a medical congress later this year. Based on the results of this trial, the company is planning to initiate a phase 3 trial in Chinese patients with overweight or obesity."

New P3 trial • P2 data • Obesity

Novo Nordisk Expands Obesity Pipeline With New Phase 2 Trial for UBT251 (TipRanks) - "This is a Phase 2 interventional trial where participants are randomly assigned to different groups. It uses a parallel design, meaning groups are treated at the same time, and it is double-blinded so neither patients nor doctors know who gets UBT251 or placebo, with the main goal being treatment of overweight and obesity."

Trial status • Obesity