Safety and Efficacy of NA-931 and Tirzepatide in Adults Who Are Overweight or Obese

Biomed Industries

Status and phase: Not yet enrolling; Phase 2

Conditions: Obesity and Overweight

Treatments: Drug: NA-931 150 mg + no Tirzepatide; Drug: NA-931; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06732245

NA-931-200

Details and patient eligibility

About

A phase 2 study to assess the efficacy of NA-931 alone or in addition to Tirzepatide to assess efficacy and safety in overweight or obese men and women

Full description

This Phase 2 study investigates if NA-931 in addition to Tirzepatide can demonstrate synergic effects by enhancing efficacy and reducing adverse events including preserve/increase muscle mass in the presence of weight and/or fat mass loss.

Enrollment: 224 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A written informed consent must be obtained before any study-related assessments are performed.

• Men and women between 18 and 80 years, inclusive; women of child-bearing potential (defined as those who are not post-menopausal or post-surgical sterilization) must meet both of the following criteria:

  • Two negative pregnancy tests (at screening and at randomization, prior to dosing)
  • Use of intrauterine device, from at least 3 months before the baseline visit through at least 4 months after the last dose of NA-931/placebo oral, and an additional contraceptive (barrier) method from screening through at least 4 months after the last dose of NA-931/placebo oral.

• Body mass index (BMI) ≥ 30 or BMI ≥ 27 with one or more obesity-associated comorbidities (e.g., hypertension, insulin resistance, sleep apnea, or dyslipidemia)

• Stable body weight (± 5 kg) within 90 days of screening, and body weight <150 kg

• Have a history of at least one self-reported unsuccessful behavioral effort to lose body weight

• Able to communicate well with the Investigator, comply with the study requirements and adhere to the diet and activity programs for the study duration

Exclusion criteria

• • History of, or known hypersensitivity to, monoclonal antibody drugs or a contraindication to Tirzepatide (Zepbound® or Mounjaro®)

  • Use of other investigational drugs at the time of enrollment or within 30 days or 5 half-lives of enrollment, whichever is longer, or longer if required by local regulations
  • Treatment with any medication for the indication of obesity within the past 30 days before screening
  • Diagnosis of diabetes requiring current use of any antidiabetic drug or HbA1c ≥ 6.5% Note: Metabolic syndrome is not an exclusion, even if managed with an anti-diabetic drug such as metformin or an SGLT2 inhibitor. A diagnosis of prediabetes or impaired glucose tolerance managed exclusively with non-pharmacologic approaches (e.g., diet and exercise) is not an exclusion.
  • Any chronic infections likely to interfere with study conduct or interpretation such as hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV). History of hepatitis A or hepatitis C successfully treated is not exclusionary. Active COVID-19 infection.
  • Donation or loss of 400 mL or more of blood within 8 weeks prior to initial dosing, or longer if required by local regulation, or plasma donation (> 250 mL) within 14 days prior to the first dose
  • Any disorder, unwillingness, or inability not covered by any of the other exclusion criteria, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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224 participants in 9 patient groups, including a placebo group

Placebo Comparator: Placebo

Placebo Comparator group

Description:

Placebo Comparator: Placebo to oral NA-931 120 mg daily + no Tirzepatide Participants will receive oral placebo at baseline and at Weeks 4, 12, and 24, 36, and 48 during the core treatment period and will switch during the extension period to receive NA-931 60 mg daily at Weeks 60 and 72.

Treatment:

Drug: NA-931

Drug: NA-931

Drug: NA-931

Drug: NA-931

Drug: NA-931

Drug: NA-931

Placebo + Tirzepatide 5 mg

Placebo Comparator group

Description:

Other: Placebo + Tirzepatide 5 mg Participants will receive oral placebo at baseline and at Weeks 4, 12, and 24, 36, and 48, and s.c. Tirzepatide 5 mg weekly per the dose escalation schedule.

Treatment:

Drug: NA-931

Drug: NA-931

Drug: NA-931

Drug: NA-931

Drug: NA-931

Drug: NA-931

Placebo + Tirzepatide 10 mg

Placebo Comparator group

Description:

Placebo + Tirzepatide 10 mg Participants will receive oral placebo at baseline and at Weeks 4, 12, and 24, 36, and 48 and s.c. Tirzepatide 10 mg weekly per the dose escalation schedule.

Treatment:

Drug: NA-931 150 mg + no Tirzepatide

NA-931 60mg to NA-931 150 mg + no Tirzepatide

Experimental group

Description:

Experimental: NA-931 60mg to NA-931 150 mg + no Tirzepatide Participants will receive oral NA-931 60 mg at baseline and at Weeks 4, 12, and 24, 36, and 48 during the core treatment period and will switch during the extension period to receive NA-931 60 mg at Weeks 60 and 72.

Treatment:

Drug: NA-931

Drug: NA-931

Drug: NA-931

Drug: NA-931

Drug: NA-931

Drug: NA-931

NA-931 60 mg + Tirzepatide 5 mg

Active Comparator group

Description:

NA-931 60 mg + Tirzepatide 5 mg Participants will receive oral NA-931 60 mg at baseline and at Weeks 4, 12, and 24, 36, and 48 and s.c. Tirzepatide 5 mg weekly per the dose escalation schedule.

Treatment:

Drug: NA-931

Drug: NA-931

Drug: NA-931

Drug: NA-931

Drug: NA-931

Drug: NA-931

NA-931 120 mg + Tirzepatide 5 mg

Active Comparator group

Description:

NA-931 120 mg + Tirzepatide 5 mg Participants will receive oral NA-931 60 mg at baseline and at Weeks 4, 12, and 24, 36, and 48 and s.c. Tirzepatide 5 mg weekly per the dose escalation schedule.

Treatment:

Drug: NA-931

Drug: NA-931

Drug: NA-931

Drug: NA-931

Drug: NA-931

Drug: NA-931

NA-931 150 mg + no Tirzepatide

Experimental group

Description:

Experimental: NA-931 150 mg + no Tirzepatide Participants will receive oral NA-931 150 mg at baseline and at Weeks 4, 12, 24, 36 and 48

Treatment:

Drug: Tirzepatide

Drug: Tirzepatide

NA-931 150 mg + Tirzepatide 2.5 mg

Active Comparator group

Description:

NA-931 150 mg + Tirzepatide 2.5 mg Participants will receive oral NA-931 150 mg at baseline, and at Weeks 4, 12, and 24, 36, and 48 and s.c. Tirzepatide 2.5 mg weekly per the dose escalation schedule.

Treatment:

Drug: Tirzepatide

Drug: Tirzepatide

NA-931 150 mg + Tirzepatide 5 mg

Active Comparator group

Description:

NA-931 150 mg + Tirzepatide 5 mg Participants will receive oral NA-931 150mg at baseline and at Weeks 4, 12, and 24, 36, and 48 and s.c. Tirzepatide 5 mg per the dose escalation schedule.

Treatment:

Drug: NA-931

Drug: NA-931

Drug: NA-931

Drug: NA-931

Drug: NA-931

Drug: NA-931